Last updated: 1 August 2024
See updates below.
This post is an attempt to provide basic information about the Access Consortium, a collaborative initiative of regulatory agencies.
Click on the ‘+’ sign next to each heading to access the information under each heading.
| Date | Update |
|---|---|
| 1 Aug 2024 | Under the section Generic Medicines Work Sharing Initiative, a new sub-section, Further Information has been added. It provides a link to the Access Consortium Operational procedures for the Generic Medicines Work-Sharing Initiative (GMWSI) document which outlines the operational steps, target milestones and recommendations for the planning and the filing of the application. The latest version of the document is V4.0 of August 2024. |
| 26 Feb 2024 | New section, Terms of Reference added |
| 13 December 2023 | 1) New section added entitled Promise Pilot pathway ( (New Access Work-Sharing Pathway for Priority Procedures)) 2) In the section New Active Substance and Biosimilar Work Sharing Initiatives, sub-section About the procedure, the link to the Operational Procedures document in the last bullet point has been updated to reflect the latest version of the document Ver 1.1 of December 2023 |
| 6 Nov 2023 | New heading Advanced Therapy Medicinal Products Working Group plus relevant content added. |
| 25 April 2023 | Section entitled Joint pipeline meetings added, with relevant content. |
The Access Consortium is a collaborative initiative of the following governmental authorities that regulate human medicines and other health products:
• Therapeutic Goods Administration, Australia
• Health Canada, Canada
• Health Sciences Authority, Singapore
• Swissmedic, Switzerland
• Medicines and Healthcare products Regulatory Agency, United Kingdom
The UK is the most recent member of the consortium. Further information is available on the MHRA website here and on the Swissmedic website here.
The Consortium is committed to maximising collaboration by aligning regulatory and policy approaches, reducing duplication, and facilitating population access to high quality, safe and effective health products.
The original group (excluding the UK MHRA) was referred to as the ACSS (Australia, Canada, Switzerland and Singapore). With the addition of the UK MHRA, the Consortium changed its name to Access, reflecting the principal goal of increasing population access to health products through international collaboration and work-sharing. The Access Consortium now represents a collective population base of 150 million.
You can view the terms of reference for the Access Consortium here. The Terms of Reference document was last updated in November 2023 (Ver 1.2).
The information below is from the UK MHRA published guidance on the Access Consortium New Active Substance and Biosimilar Work Sharing Initiatives.
About the initiative
Several medicines have already been successfully approved through this international collaboration via the New Active Substance Work Sharing Initiative (NASWSI). It continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
About the procedure
- The applicant should first express interest in the initiative by using the NAS Expression of Interest (EOI) or Biosimilar Expression of Interest (EOI) form. This should be done 3 – 6 months before the target submission date.
- Identical dossiers must then be submitted (taking into account, country-specific aspects ) to the relevant participating agencies. Ideally, this should be done within a time frame of two weeks.
- The application to the MHRA must be in eCTD format and in accordance with UK regulatory requirements.
- Modules 2-5 do not have to be identical across countries. However, it is preferable that the same dossier is submitted to all the participating regulators. Where there are differences, the ‘Summary of Differences between dossiers’ (included in the EOI form) should be completed outlining the differences in information provided to each regulator.
- The Operational Procedures document for the New Active Substance Work Sharing Initiative (NASWSI) contains further details on this procedure.
Which regulatory agency(ies) review(s) the dossier?
Each agency in the consortium reviews the module(s) allocated to it for the main review. As soon as the main review of all modules is concluded, the evaluation reports will be shared via a secure IT platform.
Which regulatory agency(ies) peer review(s) the dossier?
Modules will be peer reviewed by those participating agencies that have not conducted the initial main review.
Where will the decision date for the joint review be provided?
The decision date for the joint review will be provided in the evaluation timeline, and is as agreed by the participating regulators and then communicated with the applicant.
What happens once the review and peer review are completed?
The regulatory agencies will discuss the results in a teleconference and prepare a consolidated response to be communicated to the applicant.
Will product labelling be a part of in the joint review process?
No, it will not be a part of the joint review process. There may be discussions among regulators about it during the assessment phase. However the regulators will review and determine this on a national basis, due to diverging regulatory and legal requirements.
What are the next steps if the application follows a standard review pathway?
- Clarification questions will be consolidated and sent to all local affiliates simultaneously.
- The timelines for this will be dependent on the milestones for the review agreed by the participating regulators.
- Questions specific to a given jurisdiction, such as those related to labelling, will be sent as needed and only to the local affiliate.
What are the next steps if the application follows a priority review pathway?
- Any clarification questions that are raised during the assessment period will be sent to the respective local affiliate for a response.
- The clarification questions will also be shared with the partnering regulator and their local affiliate. This is to allow for a subsequent eCTD sequence to be sent to ensure that the application is complete for all participating regulators.
How will the participating agencies make a final regulatory decision?
- Each regulator will maintain its independence in making a final decision.
- Marketing authorisation approval or refusal by one regulator may therefore not affect the decision or the timing of the decision of the remaining participating regulators.
Can an authorisation be granted for GB or the UK via the Access consortium route?
Can a marketing authorisation be granted in GB or the UK via the Access consortium route?
A marketing authorisation can be granted in GB or the UK GB although the likelihood of a GB authorisation is greater as most products authorised via this route would also quite likely be assessed by the EMA via the centralised procedure, so if an authorisation were to be granted, then Northern Ireland would be included.
Will national procedures still apply for the participating countries when posting an external summary of the application?
Yes they will e.g. UK Public Assessment Report (PAR), AusPAR, Canadian Summary Basis of Decision, SwissPAR.
What fees will apply for the procedure?
National fees will apply.
Source: MHRA
The Access Consortium working group for new active substances has established an aligned process for priority review, which includes the decision on priority status.
- In order to facilitate the process for applicants, common timelines for the priority review request have been established, and the request is evaluated in a collaborative way, seeking a consensus decision.
- In creating the Promise Pilot Pathway, the Access partners sought commonality in their respective criteria for priority review. Applications for new active substances fulfilling the following criteria are eligible for the Promise Pilot Pathway:
- diagnoses, treats or prevents a condition that is serious, life-threatening or severely debilitating and for which no other treatment is currently registered and marketed in participating jurisdictions for the proposed indication
The scope of the Promise Pathway will be further reviewed after the pilot.
Further details are available in the updated Operational Procedures document (v 1.1 December 2023) which can be downloaded here.
Sources: Swissmedic, TGA, MHRA
The information below is from the UK MHRA published guidance on the Access Consortium, Generic Medicines Work Sharing Initiative.
About the initiative:
The initiative is a work sharing model for the co-ordinated assessment of a generic application that has been filed with multiple Access Consortium agencies.
How will the procedure work?
- Applicants to the Access Consortium should express an interest in the initiative using the Expression of Interest (EOI) form. This should be done 3 – 6 months before the target submission date. The form will be provided in due course.
- Identical dossiers must be submitted (taking into account, country-specific aspects ) to the relevant agencies participating. The MHRA application must be in eCTD format, in accordance with UK regulatory requirements.
- Modules 2-5 – Whilst these do not have to be identical across countries, it is preferable that the same dossier (common information) is submitted to all the participating regulators. Where there are differences, the ‘Summary of Differences between dossiers’ (included in the EOI form) should be completed, clearly identifying and outlining the differences.
- Module 1-Submitted to each of the identified regulatory agencies should be country-specific for the respective regulatory agency.
Which will be the Reference Regulatory Agency (RRA)?
The lead agency is designated as the Reference Regulatory Agency (RRA).
It will prepare:
- the assessment reports following a full review of the dossier
- the consolidated List of Questions (LOQ) on Modules 2‐5.
Which will be the Concerned Regulatory Agencies (CRAs)?
The other participating agencies will act as the Concerned Regulatory Agencies (CRAs). They will perform a peer review of the assessment reports and the application and provide supplementary comments (as needed).
What task will the RRA and the CRAs both perform?
The RRA and the CRAs will forward the consolidated LOQ on Modules 2‐5 and their respective LOQ on Module 1 (including questions on product information and labelling) to the local affiliate.
How will the participating agencies make a final regulatory decision?
- Each agency will make its own sovereign decision based on the recommendations contained in the assessment reports.
- Marketing authorisation approval or refusal by one regulator may not affect the decision or the timing of the decision of the remaining participating regulators.
- If it becomes apparent during the process that there are insurmountable issues with the data such that the participating agencies are unable to reconcile, the agencies have the option to seek additional information and undertake further review. Such a situation is not usually anticipated.
Can a marketing authorisation be granted in GB or the UK via the Access consortium route?
A marketing authorisation can be granted in GB or the UK GB although the likelihood of a GB authorisation is greater as most products authorised via this route would also quite likely be assessed by the EMA via the centralised procedure, so if an authorisation were to be granted, then Northern Ireland would be included.
Will national procedures still apply when posting an external summary of the application?
Yes they will e.g. UK Public Assessment Report (PAR), AusPAR, Canadian Summary Basis of Decision, SwissPAR.
What fees will apply for the procedure?
National fees will apply.
Further information
Further information is provided in the Access Consortium Operational procedures for the Generic Medicines Work-Sharing Initiative (GMWSI) document which outlines the operational steps, target milestones and recommendations for the planning and the filing of the application.
The latest edition of this document is V4.0 (Aug 2024). It was updated to include:
- 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)
Source: MHRA
In 2023, the Access Consortium established a working group for advanced therapy medicinal products (ATMPs)
The main goals of this group are to:
- foster interdisciplinary (quality, non-clinical, clinical) scientific discussions on emerging innovative therapeutic concepts and technologies
- establish an interdisciplinary forum for Access members to discuss ATMP-specific topics with a focus on assessing benefits and risks and on regulatory decision-making
- encourage mutual exchange and harmonization on the regulatory assessment of ATMPs
- explore potential synergies and opportunities for work-sharing, reliance and providing joint scientific advice
- publish guidance and recommendations on common areas where the group has established a harmonized approach, where appropriate
The Access Consortium Strategic Plan 2021-2024 was endorsed by the five regulatory authorities (Consortium members) and published in June 2021.
The Access Consortium is a collaborative initiative of the following governmental authorities that regulate human medicines and other health products:
• Therapeutic Goods Administration, Australia
• Health Canada, Canada
• Health Sciences Authority, Singapore
• Swissmedic, Switzerland
• Medicines and Healthcare products Regulatory Agency, United Kingdom
The UK is the most recent member of the consortium. Further information is available on the MHRA website here and on the Swissmedic website here.
The Consortium is committed to maximising collaboration by aligning regulatory and policy approaches, reducing duplication, and facilitating population access to high quality, safe and effective health products.
The original group (excluding the UK MHRA) was referred to as the ACSS. With the addition of the UK MHRA, the Consortium changed its name to Access, reflecting the principal goal of increasing population access to health products through international collaboration and work-sharing. The Access Consortium now represents a collective population base of 150 million.
The main strategic objectives for 2021-2024 to guide the Access Consortium in achieving its vision and mission are as follows:
- Strengthening Access work-sharing initiatives in the following three areas:
- Generic Medicines Work Sharing
- New Active Substances Work Sharing Initiative
- Biosimilars Work Sharing
- Expanding lifecycle approach – This involves maximising collaboration throughout the health product lifecycle in various ways including the following:
- Consider collaboration on clinical trials design and/or sponsor advice
- Explore the use of real-world data and real-world evidence in clinical trial design and regulatory approaches
- Establish collaboration and scientific information sharing within Access on risk management, pharmacovigilance and post-market safety
- Regulatory innovation that integrates a healthcare systems approach – This involves Increasing regulatory capacity while collaborating with key national healthcare systems partners to facilitate uptake of innovative health products. It is achieved in a number of ways including:
- Strengthening and leveraging regulatory scientific capacity within Access for emerging technologies and innovative products
- Exploring collaboration with national health technology assessment organisations (and similar)
The Access goal to become regulators of choice will be measured by the following indicators of success:
- Increase in:
- applications to Access at the same time or soon after being filed with other major medicines regulators
- number of products made available to patients via Access
- diversity of products assessed via Access
- number of ICH guidelines implemented through Access collaboration
- Decrease in average time to market for products assessed under Access
- Reduced effort and duplication for both regulators and industry
- Increased collaboration on:
- the alignment of products with healthcare system needs that are made available to patients via Access
- global GxP inspections
Sources:
Pipeline meetings between the MHRA and pharmaceutical and biotechnology companies are an opportunity to exchange information on new developments and collaborate on new possibilities.
The meetings will also help Access regulators plan and prepare for future work-share applications.
Stakeholders must submit a request for a pipeline meeting.
Topics for discussion at these meetings may include any of the following:
- potential candidates for Access submissions, such as:
- biosimilars
- advanced therapy medicinal products
- generic developments for complex technologies
- new active substance candidates for standard or priority review
- requirements for future submissions involving upcoming trends, new technologies and added complexities
- for example, real world evidence, complex trials
- collective indications
- for example, tropical diseases
- early identification of challenges or possible technical barriers for harmonized submissions
- submission strategy for novel therapeutic approaches
Source: MHRA
Links are provided below to the information on the Access Consortium on the websites of the participating regulatory agencies.