www.canada.ca Open in urlscan Pro
2600:141b:1c00:248b::fe9  Public Scan

Form analysis
1 forms found in the DOM

Name: cse-search-box — GET /en/sr/srb.html

<form action="/en/sr/srb.html" method="get" name="cse-search-box" role="search">
  <div class="form-group wb-srch-qry">
    <label for="wb-srch-q" class="wb-inv">Search Canada.ca</label>
    <input id="wb-srch-q" list="wb-srch-q-ac" class="wb-srch-q form-control" name="q" type="search" value="" size="34" maxlength="170" placeholder="Search Canada.ca">
    <datalist id="wb-srch-q-ac">
    </datalist>
  </div>
  <div class="form-group submit">
    <button type="submit" id="wb-srch-sub" class="btn btn-primary btn-small" name="wb-srch-sub"><span class="glyphicon-search glyphicon"></span><span class="wb-inv">Search</span></button>
  </div>
</form>

Text Content

 * Skip to main content
 * Skip to "About government"
 * Switch to basic HTML version


LANGUAGE SELECTION

 * Français fr

/ Gouvernement du Canada


SEARCH

Search Canada.ca
Search

--------------------------------------------------------------------------------


MENU

Main Menu
 * Jobs and the workplace
   * Jobs: home
   * 
   * Find a job
   * Training
   * Hiring and managing employees
   * Starting a business
   * Workplace standards
   * Pensions and retirement
   * Employment Insurance benefits and leave
   * 
   * Most requested
     * View your records of employment
     * Submit a record of employment - employers
     * Apply for a Social Insurance Number (SIN)
     * Hire a temporary foreign worker
     * Immigrate as a skilled worker
 * Immigration and citizenship
   * Immigration and citizenship: home
   * 
   * My application
   * Visit
   * Immigrate
   * Work
   * Study
   * Citizenship
   * New immigrants
   * Canadians
   * Refugees and asylum
   * Enforcement and violations
   * 
   * Most requested
     * Sign in to your IRCC account
     * Check your application status
     * Check application processing times
     * Find an application form
     * Pay your fees
     * Find out if you need an eTA or a visa to visit Canada
     * Have questions? Find answers in the Help Centre
 * Travel and tourism
   * Travel and tourism: home
   * 
   * Travel advice and advisories
   * COVID-19: Travel, testing and borders
   * Visit Canada
   * Travel outside Canada
   * Air travel
   * Return to Canada
   * Canadian passports and travel documents
   * Canadian attractions, events and experiences
   * Assistance outside Canada
   * Stay connected
   * 
   * Most requested
     * Emergency assistance abroad
     * Find out if you need a visa to travel to Canada
     * Apply for an eTA
     * Apply for NEXUS
     * Register as a Canadian abroad
     * Travel insurance
 * Business and industry
   * Business and industry: home
   * 
   * Starting a business
   * Business grants and financing
   * Business taxes
   * Federal corporations
   * Hiring and managing employees
   * International trade and investment
   * Permits, licences and regulations
   * Doing business with government
   * R&D and innovation
   * Research and business intelligence
   * Intellectual property and copyright
   * Maintaining your business
   * Protecting your business
   * Insolvency for business
   * 
   * Most requested
     * Find a corporation
     * Report your imported goods
     * Search for trademarks
     * Review custom tariffs for importing goods
     * Find a patent
     * Import and export from Canada
     * Name a business
     * Make changes to your corporation (Online Filing Centre)
 * Benefits
   * Benefits: home
   * 
   * Employment Insurance benefits and leave
   * Dental coverage
   * Family and caregiving benefits
   * Public pensions
   * Grants and funding opportunities
   * Student aid and education planning
   * Housing benefits
   * Disability benefits
   * Benefits by audience
   * Benefits payment dates
   * Benefits finder
   * Notify the government of a death
   * 
   * Most requested
     * Apply for Employment Insurance
     * Apply for student loans and grants
     * Sign in to a Government of Canada online account
     * Set up or change direct deposit
     * Submit your EI report
     * Child and family benefits calculators
 * Health
   * Health: home
   * 
   * Food and nutrition
   * Diseases and conditions
   * Vaccines and immunization
   * Drug and health products
   * Product safety
   * Health risks and safety
   * Healthy living
   * Indigenous health
   * Health system and services
   * Science, research and data
   * 
   * Most requested
     * Canada's food guide
     * Recalls and safety alerts
     * Mental health support: Get help
     * Measles
 * Taxes
   * Taxes: home
   * 
   * Income tax
   * GST/HST
   * Payroll
   * Business number
   * Savings and pension plans
   * Tax credits and benefits for individuals
   * Excise taxes, duties, and levies
   * Charities and giving
   * 
   * Most requested
     * My Account
     * My Business Account
     * Represent a Client
     * File a GST/HST return (NETFILE)
     * Make a payment to the Canada Revenue Agency
     * Find the next benefit payment date
 * Environment and natural resources
   * Environment and natural resources: home
   * 
   * Weather, climate and hazards
   * Energy
   * Natural resources
   * Agriculture
   * Fisheries
   * Wildlife, plants and species
   * Pollution and waste management
   * Environmental conservation and protection
   * 
   * Most requested
     * Local weather forecast
     * Fuel-efficient vehicles
     * Home energy efficiency
     * Species at risk
     * Prepare for severe weather
 * National security and defence
   * National security and defenceDefence: home
   * 
   * National security
   * Canadian Armed Forces
   * Defence equipment purchases and upgrades
   * Transportation security
   * Securing the border
   * Cyber security
   * Jobs in national security and defence
   * Services and benefits for the military
   * 
   * Most requested
     * Jobs in the Canadian Armed Forces
     * Military ranks
     * Defence equipment
     * Current list of terrorist entities
     * Join the Cadet Program
     * Canada's Defence policy
 * Culture, history and sport
   * Culture, history and sport: home
   * 
   * Funding - Culture, history and sport
   * Events, celebrations and commemorations
   * Cultural landmarks and attractions
   * Canadian identity and society
   * Sport
   * History and heritage
   * Arts and media
   * Cultural youth programs
   * Cultural trade and investment
   * 
   * Most requested
     * Visit the Canadian Virtual War Memorial
     * Anthems and symbols of Canada
     * Find a CRTC decision
     * Research your family history
     * Search census records
     * Landmarks and attractions in Canada's capital
 * Policing, justice and emergencies
   * Policing, justice and emergencies: home
   * 
   * Policing
   * Justice
   * Emergencies
   * Corrections
   * Parole, record suspension, expungement and clemency
   * Victims of crime
   * 
   * Most requested
     * Apply/Renew a firearms licence
     * Get a criminal records check
     * Apply for a criminal record suspension
     * What to do during an emergency
     * Know the law on impaired driving
     * Help solve a crime
 * Transport and infrastructure
   * Transport and infrastructure: home
   * 
   * Aviation
   * Marine transportation
   * Road transportation
   * Rail transportation
   * Dangerous goods
   * Infrastructure
   * 
   * Most requested
     * Zero-emission vehicles
     * Drone safety
     * What you can't bring on an airplane
     * Register your vessel
     * Child car seat safety
     * Transporting dangerous goods - Regulations
     * Canadian Aviation Regulations
 * Canada and the world
   * Canada and the world: home
   * 
   * International offices and emergency contacts
   * Study, work and travel worldwide
   * Information by countries and territories
   * Stories
   * International relations
   * Global issues and international assistance
   * Funding for international initiatives
   * International trade and investment
   * 
   * Most requested
     * Find a Canadian scholarship as an international student
     * International treaties signed by Canada
     * Find international study or research opportunities in Canada
     * Contact an embassy or consulate
     * Contact a foreign representative in Canada
     * Authenticate a document
 * Money and finances
   * Money and financesFinance: home
   * 
   * Managing your money
   * Debt and borrowing
   * Savings and investments
   * Education funding
   * Pensions and retirement
   * Protection from frauds and scams
   * Financial tools and calculators
   * Financial literacy programs
   * Consumer affairs
   * Insolvency
   * Taxes
   * Government finances
   * Business grants and financing
   * Financial and money services regulation
   * 
   * Most requested
     * Find a bankruptcy or insolvency record
     * Student loans
     * Set up or change direct deposit
     * Mortgages
     * Credit report and scores
     * Make a budget
     * Rates and contribution limits
 * Science and innovation
   * Science and innovation: home
   * 
   * Research funding and awards
   * Science subjects
   * Open data, statistics and archives
   * Research institutes and facilities
   * R&D and innovation
   * Intellectual property and copyright
   * Directory of scientists and research professionals
   * Science education resources
   * 
   * Most requested
     * National building codes
     * Official times across Canada
     * Check sunrise and sunset times
     * Grants for technological innovation (IRAP)
     * Federal Science Libraries Network
     * Live view of northern lights cam


YOU ARE HERE:

 1. Canada.ca
 2. Departments and agencies
 3. Health Canada
 4. Drugs and health products
 5. Health products international activities
 6. Access Consortium


OPERATIONAL PROCEDURES FOR THE GENERIC  MEDICINES WORK-SHARING INITIATIVE

Download the alternative format (PDF format, 354 KB, 26 pages)

Document change log

Version Description of Change Author Effective Date v 1.0 Original publication
ACSS Generic Medicines WG 2016-05-20 v 2.0 Updated following the first
application with the GMWST ACSS Generic Medicines WG 2017-10-05 v 3.0 Updated to
include process enhancements based on experiences with the work sharing model,
recent developments (e.g., addition of UK's MHRA to the Access Consortium) and
feedback received from stakeholders. Access Generic Medicines WG 2022-10-30 v
4.0 Updated to include Appendix 1 and 2 to include more detail on acceptance of
foreign comparator products in bioequivalence studies in each Access Country
Access Generic Medicines WG 2024-08-01


TABLE OF CONTENTS

 * Introduction
 * Scope
 * Application considerations
 * Operational approach
   * Pre-submission meeting/teleconference (minimum 2 months in advance)
   * Submitting application (less than 15 days)
   * Accepting application (15 days)
 * Round 1 assessment
   * Initial assessment by the RRA (60 days)
   * Peer review by CRAs (25 days)
   * Finalising ARs and LoQs (5 days)
   * Submitting responses to the LoQ by applicant (30 or 60 days)
 * Round 2 assessment
   * Assessing responses to LoQ (30 days)
   * Peer review by CRAs (15 days)
   * Finalising ARs and additional LoQ (5 days)
   * Submitting responses to the additional LoQ (if applicable) (15 days)
 * Round 3 assessment (if applicable)
   * Assessing responses to the additional LoQ (15 days)
   * Peer review of responses by the CRAs, finalising the ARs and additional LoQ
     (if applicable) (5 days)
 * National steps
 * Related links
 * Appendix 1: Access countries that will accept a previously conducted
   bioequivalence (BE) study using a Foreign Comparator Product (FCP)
 * Appendix 2: Current regulatory requirements regarding the acceptance of
   Foreign Comparator Products (FCPs)


INTRODUCTION

This document outlines operational procedures and recommendations for planning
and implementing the Generic Medicines Work-sharing Initiative (GMWSI) for the
regulatory agencies within the Access Consortium. The agencies are:

 * Therapeutic Goods Administration (TGA), Australia
 * Health Canada (HC), Canada
 * Health Sciences Authority (HSA), Singapore
 * Swissmedic (SMC), Switzerland
 * Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
   (UK)

The initiative is based on Europe's decentralized procedure, where 1 agency acts
as a reference regulatory agency (RRA) and will evaluate Modules 2 to 5. Each
participating agency acts as a concerned regulatory agency (CRA) and, with the
RRA, evaluates their respective module 1. The CRAs peer review the assessment
reports (ARs) and the proposed List of Questions (LoQ) provided by the RRA on
Modules 2 to 5, consult the modules where necessary and provide supplementary
comments as needed.

Each agency makes its own decision based on the recommendations made in the ARs.
If, during the process, the participating agencies are unable to reconcile
issues with the data, the agencies may seek additional information and undertake
further independent review.


SCOPE

To be considered for this initiative, the proposed product should be regarded as
a generic product by all the participating agencies. All pharmaceutical (dosage)
forms are eligible.


APPLICATION CONSIDERATIONS

An applicant wishing to participate in this innovative work-sharing initiative
must submit an Expression of Interest (EoI) form to each agency proposed for
this initiative. The applicant should submit this form at least 3 months before
the planned submission date.

Applications for this initiative should be submitted at the same time to at
least 2 of the Access Consortium members.

The applicant should submit the same Modules 2 to 5 to all of the agencies
involved in the initiative. However, there may be minor differences in the
applications submitted to the various agencies participating in the initiative.
For example, there may be differences in packaging formats such as bottles
versus unit dose blisters. Major differences between applications may make the
work-sharing process more complicated, which may delay the assessment process.
For example, submitting multiple studies using different comparator products
would be considered a major difference.

If there are minor differences between datasets, the applicant should provide a
'Summary of Differences' table. This table is part of the EoI form. The table
should outline the differences in the quality and bioequivalence study
information provided to each participating agency. The Access agencies will
discuss these differences and determine if the application is suitable for
GMWSI.

Please note that all Access agencies accept the use of foreign comparator
products in bioequivalence studies. Therefore, for submissions requiring
clinical equivalence (whether pharmacokinetic bioequivalence or therapeutic
equivalence), it may be possible to use a single comparator product, along with
country-specific justifications for using the foreign comparator product. For
further information on the acceptability of a foreign comparator product in each
Access jurisdiction please see Appendix 1: Access countries that will accept a
previously conducted bioequivalence (BE) study using a Foreign Comparator
Product (FCP), and Appendix 2: Current regulatory requirements regarding the
acceptance of Foreign Comparator Products. Additional information and references
are also included in the section Related Links below.

Also note that Module 1 is specific to each Access agency. Thus, it will
continue to be different for the applications filed in the different Access
jurisdictions (as per national requirements).

Although an applicant may propose a preferred RRA, the Access agencies will
ultimately determine the RRA and CRAs for any submission. The agencies base
their decision on factors such as the Access Consortium's operational needs.

In general, 1 agency (the RRA) will perform the evaluation and the other
participating agencies will act as CRAs. However, in some cases, the application
may be split up, with multiple agencies doing the initial assessment. The roles
of each participating agency will be determined in line with operational
requirements.

In the EoI, the applicant should indicate their preferred timeframe for
submitting their responses to the LoQs provided by the agencies. The timeframe
should be either 30 or 60 calendar days.

Applications should fully address the requirements of all jurisdictions to be
included in the procedure. Applicants should also acknowledge that they will
need to work collaboratively with the agencies. While a single application that
covers broader issues for more than 1 agency may seem more onerous, it will
ultimately reduce the overall regulatory burden.


OPERATIONAL APPROACH

The process needs to work concurrently within the regulatory systems of the
participating agencies. This section outlines the steps and issues that need to
be considered when implementing the procedure.

All timelines/days are based on calendar days. If a milestone falls on a weekend
or a national holiday, the milestone is the preceding business day. Please note
that the following timeframes are target timeframes and may be adjusted
depending on the complexity of the application.


PRE-SUBMISSION MEETING/TELECONFERENCE (MINIMUM 2 MONTHS IN ADVANCE)

Once the participating agencies receive an EoI form, they will work together to
discuss the application, its suitability for inclusion in the work-sharing
initiative, the RRA and CRAs, and next steps.

A pre-submission meeting/teleconference between the applicant and their local
Access agency, or all participating agencies if possible (may not be granted due
to operational and resource challenges), is strongly recommended. This meeting
is used to discuss the technical aspects of the submission, and to confirm the
logistics and expectations related to requirements, timelines for assessment and
the process. The meeting also gives agencies a chance to respond to any
additional questions the applicant may have.

The teleconference should take place at least 2 months before the agreed-upon
submission date of the application. The applicant must follow the usual
procedures of their local agency when requesting a pre-submission meeting.

The applicant will be asked to provide their questions at least 2 weeks before
the pre-submission teleconference. Within 2 weeks of this teleconference, the
applicant must provide a record of the meeting, summarizing the points that have
been agreed to.


SUBMITTING APPLICATION (LESS THAN 15 DAYS)

Applications should be submitted to each participating agency at the same time
or as agreed with the participating agencies. The process begins as soon as all
agencies have received the applications. This is "Day -15" of the process.

If applicable, the Active Substance Master File/Drug Master File must be
submitted to each participating agency before the application is filed, with the
appropriate local forms.


ACCEPTING APPLICATION (15 DAYS)

Once the participating agencies receive the application, the RRA and CRAs screen
and validate the technical and administrative information. They check that their
national legislation and data requirements (for example, application forms, user
fees) have been met and that the application can be accepted for assessment.

The RRA and CRAs then inform the applicant if their application has been
accepted for assessment. If accepted, the applicant is also given a summary of
the target timeframes for each step in the process. The day of acceptance of the
application for assessment by the RRA is "Day 0" of the process. The CRAs will
make efforts to accept the application on the same day as the RRA.


ROUND 1 ASSESSMENT


INITIAL ASSESSMENT BY THE RRA (60 DAYS)

The RRA evaluates Modules 2 to 5 and prepares an AR and an LoQ. At the same
time, the RRA and CRAs evaluate their national Module 1 and prepare an LoQ for
this module. The RRA then shares the AR and LOQ on Modules 2 to 5 with the CRAs.

While a consolidated LoQ is the preferred option, the RRA may instead send
rolling questions to the local applicant to seek clarification during the
assessment process. If applicable, the responses to these clarification
questions have a short timeframe (for example, 5 days). The RRA then shares
these responses with the CRAs.


PEER REVIEW BY CRAS (25 DAYS)

As part of the peer review process, the CRAs:

 * conduct a peer review of the AR and LoQ
 * consult the modules (as needed)
 * share comments and additional questions on Modules 2 to 5 with the RRA


FINALISING ARS AND LOQS (5 DAYS)

The RRA and CRAs discuss the LoQ and any additional questions. The RRA prepares
the consolidated LoQ on Modules 2 to 5. The RRA and each CRA forward the
consolidated LoQ, as well as their questions on Module 1 (includes questions on
product information and labelling), to their local applicant.


SUBMITTING RESPONSES TO THE LOQ BY APPLICANT (30 OR 60 DAYS)

The applicant prepares and sends the same responses to the LoQ on Modules 2 to 5
to the RRA and CRAs by way of the respective local applicants. At the same time,
the local applicant sends responses to the Module 1 questions to their
respective agencies.

As stated, the applicant should indicate in the EoI their preferred timeframe
for submitting responses to the LoQ (either 30 or 60 days). However, the
applicant will be able to respond any time after 30 days and before 60 days.


ROUND 2 ASSESSMENT


ASSESSING RESPONSES TO LOQ (30 DAYS)

The RRA prepares an AR of the responses on the consolidated LoQ for Modules 2 to
5 and shares it with the CRAs. At the same time, the RRA and CRAs prepare an AR
of the responses to their respective country-specific questions on Module 1.


PEER REVIEW BY CRAS (15 DAYS)

The CRAs conduct a peer review of the AR of the responses to Modules 2 to 5 and
provide feedback. If necessary, the RRA prepares an additional LoQ, which each
agency sends to the local applicant. The 15-day timeframe includes the time for
peer review and for any coordination between the RRA and the CRAs.


FINALISING ARS AND ADDITIONAL LOQ (5 DAYS)

If an additional LoQ (in general, this corresponds to the preliminary decision
in Switzerland) is not necessary, each agency makes a final decision. The
agencies also undertake the necessary administrative steps to finalise the
process for their country.


SUBMITTING RESPONSES TO THE ADDITIONAL LOQ (IF APPLICABLE) (15 DAYS)

The applicant prepares and sends responses to the additional LoQ (if applicable)
to the RRA and CRAs.


ROUND 3 ASSESSMENT (IF APPLICABLE)


ASSESSING RESPONSES TO THE ADDITIONAL LOQ (15 DAYS)

The RRA prepares an AR of the responses to the additional LoQ following the
process described for round 2.


PEER REVIEW OF RESPONSES BY THE CRAS, FINALISING THE ARS AND ADDITIONAL LOQ (IF
APPLICABLE) (5 DAYS)

The CRAs conduct a peer review of the responses and provide feedback in order
for the RRA to finalise the AR.


NATIONAL STEPS

Each agency makes a final decision (or seeks further clarification on issues
separately before making a final decision) and undertakes the necessary
administrative steps to finalise the process nationally. Depending on each
agency's assessment outcome, an authorisation letter or additional questions is
issued.

These communications may not necessarily happen at the same time.

Total maximum elapsed timeframe from when the application is accepted (day 0) to
the start of the national steps:

 * 170 to 200 calendar days (including the applicant's response time and if only
   1 list of questions is required) or
 * 205 to 235 calendar days (if an additional list of questions is required)

Figure 1: Schematic representation of the expected milestones and timelines for
the various steps in the process Text description

Figure 1 shows the process milestones and timelines for the application
lifecycle. First, the applicant submits the Expression of Interest form. 3 or
more months later, a pre-submission meeting may be held. 2 or more months later,
the application for market authorization is filed to the participating Access
agencies. After another 15 days, the agencies accept the application into
review. 90 days later, the List of Questions stemming from the application
assessment are issued to the applicant. 30-60 days later, the applicant submits
their response to the List of Questions. After 50 days of reviewing the response
to the List of Questions, the agencies issue additional Lists of Questions, a
preliminary decision, or perform the national steps towards a final decision.
Within 15 days, the applicant then submits responses to the additional List of
Questions, or preliminary decision, as applicable. 20 days later, the agencies
have assessed the responses to the additional List of Questions or preliminary
decision, as applicable, and perform the national steps towards the final
decision.

Any further questions about this initiative can be directed to the local
regulatory authority:

 * Australia: PMABinternationalevaluations@health.gov.au
 * Canada: collaboration@hc-sc.gc.ca
 * Singapore: HSA_TP_Enquiry@hsa.gov.sg
 * Switzerland: Access@swissmedic.ch
 * United Kingdom: Access-MHRA@mhra.gov.uk

Communications by e-mail should include "Access Consortium - GMWSI" in the
subject line.


APPENDIX 1: ACCESS COUNTRIES THAT WILL ACCEPT A PREVIOUSLY CONDUCTED
BIOEQUIVALENCE (BE) STUDY USING A FOREIGN COMPARATOR PRODUCT (FCP)

BE study used a Comparator Product (CP) from? Access Country Potentially
Acceptable Key CriteriaFootnote 1 Key Exceptions/other commentsFootnote 2 Europe
(EMA Country) Australia Yes FCP and local CP are identical in appearanceFootnote
3, are from the same global company and have similar dissolution. Only applies
to oral dosage forms. Contact the TGA for other dosage forms. Canada Yes The
formulation of the FCP and the local CP are qualitatively and quantitatively the
sameFootnote 1 and are from the same innovator company or corporate entity. The
medicinal ingredient is considered to have high solubility. Depending on the
drug product, comparative dissolution data, comparative physicochemical property
data, in-vitro performance data or device attribute data may also be required.
Modified release products (exceptions may apply). Immediate release drug
products that contain Critical Dose Drugs or a drug substance that is not
considered to have high solubility. Singapore Yes FCP is from the same global
company as Singapore reference product (SRP) or marketed in its country of
origin through a licensing arrangement with the Singapore Product Registrant.
Comparative dissolution data are only required if the FCP is not manufactured at
the same drug product manufacturing site as the SRP. FCP which are narrow
therapeutic index drugs and not manufactured at the same drug product
manufacturing site as the SRP will not be accepted. Switzerland Yes
Pharmaceutical bridging between FCP and local RP is eligible as long as the
criteria listed in the respective guidance documentFootnote 1 are fulfilled.
These criteria cover, among others, composition, aspects concerning the
pharmaceutical form including dimension/weight as well as release mechanism, and
dissolution profiles. No exceptions. United Kingdom Yes Part of same Global
Marketing Authorisation (GMA) as United Kingdom approved Reference Medicinal
Product (RMP). Will also accept use of the concept of the European Reference
Product (ERP) in particular cases. If the ERP to be used, advise to discuss in
advance with MHRA. In some cases, it may be accepted to perform studies using
another CP, product X, that was itself submitted as an application referring to
the RMP (eg new indications, strength, route of administration, pharmaceutical
form), but is not part of the same GMA as the RMP. Additional non-clinical
and/or clinical studies would have been submitted in support of product X.
Applicants are advised to discuss the dossier requirements in such situations
with the MHRA. Great BritainFootnote 4 Yes Part of same GMA as United
Kingdom/Great Britain approved RMP. In some cases, it may be accepted to perform
studies using another CP, product X, that was itself submitted as an application
referring to the RMP (eg new indications, strength, route of administration,
pharmaceutical form), but is not part of the same GMA as the RMP. Additional
non-clinical and/or clinical studies would have been submitted in support of
product X. Applicants are advised to discuss the dossier requirements in such
situations with the MHRA. United States of America Australia Yes FCP and local
CP are identical in appearanceFootnote 3, are from the same global company and
have similar dissolution. Only applies to oral dosage forms. Contact the TGA for
other dosage forms. Canada Yes The formulation of the FCP and the local CP are
qualitatively and quantitatively the sameFootnote 1 and are from the same
innovator company or corporate entity. The medicinal ingredient is considered to
have high solubility. Depending on the drug product, comparative dissolution
data, comparative physicochemical property data, in-vitro performance data or
device attribute data may also be required. Modified release products
(exceptions may apply). Immediate release drug products that contain Critical
Dose Drugs or a drug substance that is not considered to have high solubility.
Singapore Yes FCP is from the same global company as Singapore reference product
(SRP) or marketed in its country of origin through a licensing arrangement with
the Singapore Product Registrant.
Comparative dissolution data are only required if the FCP is not manufactured at
the same drug product manufacturing site as the SRP. FCP which are narrow
therapeutic index drugs and not manufactured at the same drug product
manufacturing site as the SRP will not be accepted. Switzerland Yes
Pharmaceutical bridging between FCP and local RP is eligible as long as the
criteria listed in the respective guidance documentFootnote 1 are fulfilled.
These criteria cover, among others, composition, aspects concerning the
pharmaceutical form including dimension/weight as well as release mechanism, and
dissolution profiles. No exceptions. United Kingdom No N/A EU requirements apply
to applications submitted to United Kingdom Great BritainFootnote 4 Yes The
non-Great Britain CP would normally be expected to be:
 * part of the same GMA as the RMP, or
 * marketed in the country of origin through a licensing arrangement with the
   innovator company or corporate entity that currently markets the medicine in
   the Great Britain.

The non-Great Britain CP used is required to be representative of the RMP, but
it is not required to be identical to it. This means that certain minor
differences between both products may be accepted if justified, provided this is
supported by bridging data (see published guidance on data requirements).
Applies to BE, PK and TE studies provided in support of generic/hybrid
applications. In case of complex products, it is recommended that MHRA are
consulted for specific advice.
In some cases, it may be accepted to perform studies using another CP, product
X, that was itself submitted as an application referring to the RMP (eg new
indications, strength, route of administration, pharmaceutical form), but is not
part of the same GMA as the RMP. Additional non-clinical and/or clinical studies
would have been submitted in support of product X. Applicants are advised to
discuss the dossier requirements in such situations with the MHRA. Canada
Australia Yes FCP and local CP are identical in appearanceFootnote 3, are from
the same global company and have similar dissolution. Only applies to oral
dosage forms. Contact the TGA for other dosage forms. Canada Yes Canadian
Comparator Product always accepted ----- Singapore Yes FCP is from the same
global company as Singapore reference product (SRP) or marketed in its country
of origin through a licensing arrangement with the Singapore Product Registrant.
Comparative dissolution data are only required if the FCP is not manufactured at
the same drug product manufacturing site as the SRP. FCP which are narrow
therapeutic index drugs and not manufactured at the same drug product
manufacturing site as the SRP will not be accepted. Switzerland Yes
Pharmaceutical bridging between FCP and local RP is eligible as long as the
criteria listed in the respective guidance documentFootnote 1 are fulfilled.
These criteria cover, among others, composition, aspects concerning the
pharmaceutical form including dimension/weight as well as release mechanism, and
dissolution profiles. No exceptions. United Kingdom No N/A EU requirements apply
to applications submitted to United Kingdom Great BritainFootnote 4 Yes The
non-Great Britain CP would normally be expected to be:
 * part of the same GMA as the RMP, or
 * marketed in the country of origin through a licensing arrangement with the
   innovator company or corporate entity that currently markets the medicine in
   the Great Britain.

The non-Great Britain CP used is required to be representative of the RMP, but
it is not required to be identical to it. This means that certain minor
differences between both products may be accepted if justified, provided this is
supported by bridging data (see published guidance on data requirements).
Applies to BE, PK and TE studies provided in support of generic/hybrid
applications. In case of complex products, it is recommended that MHRA are
consulted for specific advice.

In some cases, it may be accepted to perform studies using another CP, product
X, that was itself submitted as an application referring to the RMP (eg new
indications, strength, route of administration, pharmaceutical form), but is not
part of the same GMA as the RMP. Additional non-clinical and/or clinical studies
would have been submitted in support of product X. Applicants are advised to
discuss the dossier requirements in such situations with the MHRA.

Australia Australia Yes Australian Comparator Product always accepted ------
Canada Yes The formulation of the FCP and the local CP are qualitatively and
quantitatively the sameFootnote 1 and are from the same innovator company or
corporate entity. The medicinal ingredient is considered to have high
solubility. Depending on the drug product, comparative dissolution data,
comparative physicochemical property data, in-vitro performance data or device
attribute data may also be required. Modified release products (exceptions may
apply). Immediate release drug products that contain Critical Dose Drugs or a
drug substance that is not considered to have high solubility. Singapore Yes FCP
is from the same global company as Singapore reference product (SRP) or marketed
in its country of origin through a licensing arrangement with the Singapore
Product Registrant.
Comparative dissolution data are only required if the FCP is not manufactured at
the same drug product manufacturing site as the SRP. FCP which are narrow
therapeutic index drugs and not manufactured at the same drug product
manufacturing site as the SRP will not be accepted. Switzerland Yes
Pharmaceutical bridging between FCP and local RP is eligible as long as the
criteria listed in the respective guidance documentFootnote 1 are fulfilled.
These criteria cover, among others, composition, aspects concerning the
pharmaceutical form including dimension/weight as well as release mechanism, and
dissolution profiles. No exceptions. United Kingdom No N/A EU requirements apply
to applications submitted to United Kingdom Great BritainFootnote 4 Yes The
non-Great Britain CP would normally be expected to be:
 * part of the same GMA as the RMP, or
 * marketed in the country of origin through a licensing arrangement with the
   innovator company or corporate entity that currently markets the medicine in
   the Great Britain.

The non-Great Britain CP used is required to be representative of the RMP, but
it is not required to be identical to it. This means that certain minor
differences between both products may be accepted if justified, provided this is
supported by bridging data (see published guidance on data requirements).
Applies to BE, PK and TE studies provided in support of generic/hybrid
applications. In case of complex products, it is recommended that MHRA are
consulted for specific advice.

In some cases, it may be accepted to perform studies using another CP, product
X, that was itself submitted as an application referring to the RMP (eg new
indications, strength, route of administration, pharmaceutical form), but is not
part of the same GMA as the RMP. Additional non-clinical and/or clinical studies
would have been submitted in support of product X. Applicants are advised to
discuss the dossier requirements in such situations with the MHRA.

Singapore Australia Yes FCP and local CP are identical in appearanceFootnote 3,
are from the same global company and have similar dissolution. Only applies to
oral dosage forms. Contact the TGA for other dosage forms. Canada Yes The
formulation of the FCP and the local CP are qualitatively and quantitatively the
sameFootnote 1 and are from the same innovator company or corporate entity. The
medicinal ingredient is considered to have high solubility. Depending on the
drug product, comparative dissolution data, comparative physicochemical property
data, in-vitro performance data or device attribute data may also be required.
Modified release products (exceptions may apply). Immediate release drug
products that contain Critical Dose Drugs or a drug substance that is not
considered to have high solubility. Singapore Yes Singaporean Comparator Product
always accepted ----- Switzerland Yes Pharmaceutical bridging between FCP and
local RP is eligible as long as the criteria listed in the respective guidance
documentFootnote 1 are fulfilled. These criteria cover, among others,
composition, aspects concerning the pharmaceutical form including
dimension/weight as well as release mechanism, and dissolution profiles. No
exceptions. United Kingdom No N/A EU requirements apply to applications
submitted to United Kingdom Great BritainFootnote 4 Yes The non-Great
Britain CP would normally be expected to be:
 * part of the same GMA as the RMP, or
 * marketed in the country of origin through a licensing arrangement with the
   innovator company or corporate entity that currently markets the medicine in
   the Great Britain.

The non-Great Britain CP used is required to be representative of the RMP, but
it is not required to be identical to it. This means that certain minor
differences between both products may be accepted if justified, provided this is
supported by bridging data (see published guidance on data requirements).
Applies to BE, PK and TE studies provided in support of generic/hybrid
applications. In case of complex products, it is recommended that MHRA are
consulted for specific advice.
In some cases, it may be accepted to perform studies using another CP, product
X, that was itself submitted as an application referring to the RMP (eg new
indications, strength, route of administration, pharmaceutical form), but is not
part of the same GMA as the RMP. Additional non-clinical and/or clinical studies
would have been submitted in support of product X. Applicants are advised to
discuss the dossier requirements in such situations with the MHRA. Switzerland
Australia Yes FCP and local CP are identical in appearanceFootnote 3, are from
the same global company and have similar dissolution. Only applies to oral
dosage forms. Contact the TGA for other dosage forms. Canada Yes The formulation
of the FCP and the local CP are qualitatively and quantitatively the
sameFootnote 1 and are from the same innovator company or corporate entity. The
medicinal ingredient is considered to have high solubility. Depending on the
drug product, comparative dissolution data, comparative physicochemical property
data, in-vitro performance data or device attribute data may also be required.
Modified release products (exceptions may apply). Immediate release drug
products that contain Critical Dose Drugs or a drug substance that is not
considered to have high solubility. Singapore Yes FCP is from same global
company as Singapore reference product (SRP) or marketed in its country of
origin through a licensing arrangement with the Singapore Product Registrant.
Comparative dissolution data are only required if the FCP is not manufactured at
the same drug product manufacturing site as the SRP. FCP which are narrow
therapeutic index drugs and not manufactured at the same drug product
manufacturing site as the SRP will not be accepted. Switzerland Yes Swiss
Comparator Product always accepted ----- United Kingdom No N/A EU requirements
apply to applications submitted to United Kingdom Great BritainFootnote 4 Yes
The non-Great Britain CP would normally be expected to be:
 * part of the same GMA as the RMP, or
 * marketed in the country of origin through a licensing arrangement with the
   innovator company or corporate entity that currently markets the medicine in
   the Great Britain.

The non-Great Britain CP used is required to be representative of the RMP, but
it is not required to be identical to it. This means that certain minor
differences between both products may be accepted if justified, provided this is
supported by bridging data (see published guidance on data requirements).
Applies to BE, PK and TE studies provided in support of generic/hybrid
applications. In case of complex products, it is recommended that MHRA are
consulted for specific advice.
In some cases, it may be accepted to perform studies using another CP, product
X, that was itself submitted as an application referring to the RMP (eg new
indications, strength, route of administration, pharmaceutical form), but is not
part of the same GMA as the RMP. Additional non-clinical and/or clinical studies
would have been submitted in support of product X. Applicants are advised to
discuss the dossier requirements in such situations with the MHRA. Great Britain
(United Kingdom other than Northern Ireland) Australia Yes FCP and local CP are
identical in appearanceFootnote 3, are from the same global company and have
similar dissolution. Only applies to oral dosage forms. Contact the TGA for
other dosage forms. Canada Yes The formulation of the FCP and the local CP are
qualitatively and quantitatively the sameFootnote 1 and are from the same
innovator company or corporate entity. The medicinal ingredient is considered to
have high solubility. Depending on the drug product, comparative dissolution
data, comparative physicochemical property data, in-vitro performance data or
device attribute data may also be required. Modified release products
(exceptions may apply). Immediate release drug products that contain Critical
Dose Drugs or a drug substance that is not considered to have high solubility.
Singapore Yes FCP is from same global company as Singapore reference product
(SRP) or marketed in its country of origin through a licensing arrangement with
the Singapore Product Registrant.
Comparative dissolution data are only required if the FCP is not manufactured at
the same drug product manufacturing site as the SRP. FCP which are narrow
therapeutic index drugs and not manufactured at the same drug product
manufacturing site as the SRP will not be accepted. Switzerland Yes     United
Kingdom Yes Great Britain comparator product accepted if part of same GMA as the
cited RMP. Recommended to discuss with MHRA in advance.

In some cases, it may be accepted to perform studies using another CP, product
X, that was itself submitted as an application referring to the RMP (eg new
indications, strength, route of administration, pharmaceutical form), but is not
part of the same GMA as the RMP. Additional non-clinical and/or clinical studies
would have been submitted in support of product X. Applicants are advised to
discuss the dossier requirements in such situations with the MHRA.

Great BritainFootnote 4 Yes Great Britain comparator product always accepted In
some cases, it may be accepted to perform studies using another CP, product X,
that was itself submitted as an application referring to the RMP (eg new
indications, strength, route of administration, pharmaceutical form), but is not
part of the same GMA as the RMP. Additional non-clinical and/or clinical studies
would have been submitted in support of product X. Applicants are advised to
discuss the dossier requirements in such situations with the MHRA.

Footnote 1

Further information can be found in Appendix 2 below and the Access Country
specific guidelines. Australia: The Australian Regulatory Guidelines for
Prescription Medicines (ARGPM) presents both a decision tree and checklist to
establish the requisite evidence Canada: Guidance Document: Use of a
Foreign-sourced Reference Product as a Canadian Reference Product (2018).
Singapore: Appendix 10 Product Interchangeability and Biowaiver Request for
Chemical Generic Drug Applications (April 2022) Switzerland:Guidance document:
Authorisation of human medicinal product with known active pharmaceutical
substance HMV4 United Kingdom: EU regulations apply Great Britain: Comparator
products in Bioequivalence/Therapeutic Equivalence studies - GOV.UK
(www.gov.uk).

Return to footnote 1 referrer

Footnote 2

Additional exceptions to the criteria outlined in Appendix 1 may exist; as a
result, the appropriate Access regulator should be consulted.

Return to footnote 2 referrer

Footnote 3

Same appearance means same size, mass, shape, colour and markings.

Return to footnote 3 referrer

Footnote 4

Great Britain is the United Kingdom without Northern Ireland. The use of a FCP
other than one sourced from the EU is allowed for such applications, but the
market is limited.

Return to footnote 4 referrer


APPENDIX 2: CURRENT REGULATORY REQUIREMENTS REGARDING THE ACCEPTANCE OF FOREIGN
COMPARATOR PRODUCTS (FCPS)

The following table summarises the current criteria for accepting FCPs among the
Access countries.

Core requirements for accepting foreign comparator products (Yes: Permitted; No:
Not permitted)

Foreign Comparator Criteria TGA HC HSA Swissmedic MHRA* Drug substance
properties Narrow Therapeutic Index/Critical Dose Yes No Yes# Yes (Yes)**
Complicated PK, variable/incomplete absorption, substantial first pass
metabolism Yes (Yes)** Yes Yes (Yes)** Low solubility Yes No Yes Yes Yes Drug
product properties Immediate-release Yes Yes Yes Yes Yes Modified-release
(delayed and sustained) Yes (No)** Yes Yes (Yes)** Inhalation products Yes Yes
Yes Yes (Yes)** Nasal products Yes Yes Yes Yes (Yes)** Similar drug product
physical characteristics
(e.g. size, weight, shape, colour, scoring, coating) Yes Yes Yes Yes (Yes)***
Similar excipient composition Yes Yes Yes Yes Yes Comparable physicochemical
testing other than dissolution Yes Yes Yes Yes Yes * Please note that
applications to Northern Ireland or the whole of the United Kingdom (including
Northern Ireland) require compliance with EU legislation at present, i.e.
require use of a comparator product approved in the EU/EEA. Foreign comparator
products may therefore only be used for applications made in Great Britain.
** Pre-application discussion with MHRA or Health Canada is recommended in these
cases to confirm acceptability of approach.
*** Certain minor differences between both products may be accepted if
justified, provided this is supported by bridging data.
# FRPs can be accepted only if they were manufactured at the same drug product
manufacturing site as the Singapore reference product.


RELATED LINKS

 * A survey of the regulatory requirements for the acceptance of foreign
   comparator products by participating regulators and organizations of the
   International Generic Drug Regulators Programme
 * Biopharmaceutic studies (TGA guidance)
 * Comparator products in bioequivalence/therapeutic equivalence studies (MHRA
   guidance)
 * Guidance document: Use of a foreign-sourced reference product as a Canadian
   reference product (HC guidance)
 * Guidance on therapeutic product registration in Singapore: Product
   interchangeability and biowaiver request for chemical generic drugs
   application (HSA guidance)
 * Guidance document: Authorisation of human medicinal product with known active
   pharmaceutical substances HMV4 (SMC guidance)


PAGE DETAILS

Date modified: 2024-07-31





ABOUT THIS SITE


HEALTH CANADA

 * Contact us


GOVERNMENT OF CANADA

 * All contacts
 * Departments and agencies
 * About government

THEMES AND TOPICS

 * Jobs
 * Immigration and citizenship
 * Travel and tourism
 * Business
 * Benefits
 * Health
 * Taxes
 * Environment and natural resources
 * National security and defence
 * Culture, history and sport
 * Policing, justice and emergencies
 * Transport and infrastructure
 * Canada and the world
 * Money and finance
 * Science and innovation
 * Indigenous peoples
 * Veterans and military
 * Youth


GOVERNMENT OF CANADA CORPORATE

 * Social media
 * Mobile applications
 * About Canada.ca
 * Terms and conditions
 * Privacy