The Access Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore's Health Sciences Authority (HSA), the Swiss Agency for Therapeutic Products (Swissmedic) of Switzerland and the Medicines and Healthcare products Regulatory Authority(MHRA) of the United Kingdom1. Regulatory authorities face very similar challenges, such as increasing workload and increasing complexities in the medicinal applications that are being regulated, thus contributing to increasing pressure on available resources. The purpose of the consortium is to build synergies and share knowledge amongst the regulatory authorities thereby enhanced efficiency of regulatory systems.
The Access Consortium consists of several working groups with various objectives and projects that aim to help meet the challenges faced by regulatory authorities, including timely access to safe therapeutic products within a limited resource capacity. The working groups use a network of bilateral confidentiality agreements and Memoranda of Understanding to conduct their work.
The Consortium explores opportunities for information and work-sharing initiatives in areas including2:
assessing therapeutic product manufacturing sites
post-market surveillance of therapeutic product safety
assessment reports for medicinal products
development of technical guidelines and regulatory standards
collaboration on information technology (IT)
1The MHRA will officially commence working with Consortium partners as a full member from 1 January 2021, with a period of shadowing before then.
2Exchange of confidential information is consistent with the provisions of existing agreements and compliant with each agency's legislative framework for sharing such information with other regulatory authorities.
The International Regulators Consortium has initiated a pilot generic medicines work-sharing programme.
The generic medicines industry is growing rapidly and becoming increasingly globalised, and generic medicines themselves – defined by Swiss law as medicines with a known active ingredient that are not the result of innovation – are becoming increasingly complex. For these reasons, the consortium has selected the approvals process for medicines with a known active ingredient that are not the result of innovation as a priority area for exploring opportunities for international collaboration. This collaboration aims to aid regulators in meeting the growing challenges, maximising use of existing specialist expertise, and ensuring a consistent, contemporary approach to assessing the safety and efficacy of generics.
The objectives of the program are to:
compare and better align regulatory requirements and approaches
use available resources more efficiently
reduce duplication and the number of regulatory hurdles
increase the predictability of evaluation time frames
increase consumer access to high-quality, safe, and effective generic medicines.
The pilot program will include:
sharing reviews
staff exchanges
identifying opportunities for regulatory alignment.
Such work will be consistent with and limited to the scope of the existing agreements under each agency's legislative framework for sharing information with other regulatory authorities.
The group has developed a new innovative authorisation procedure for "known active substances without innovation". This Generic Medicines Work Sharing Initiative (GMWSI) is comparable with the EU's decentralised procedure (DCP):
The Generic Medicines Working Group (GMWG) meets bi-annually and also holds regular teleconferences to advance the work. For more information about the proceedings and notable outcomes from the face-to-face meetings, please refer to the Public Statements:
The New Active Substance (NAS) Working Group has been set up to harmonise regulatory approaches and technical requirements in such a way that they open up new regulatory options. This was the basic idea behind the launch of an innovative project on work sharing.
New Active Substance Work Sharing Initiative (NASWSI)
The work-sharing project is a novel form of transnational cooperation between regulatory authorities and the pharmaceutical industry. The aim is to share the work associated with reviewing in a coordinated system.
Work sharing is suitable for companies that submit an authorisation application for a new chemical or biological active substance or for an additional indication simultaneously in at least two members of the ACSS Consortium.
Initially launched as a pilot project, the work sharing idea was discussed repeatedly and eventually established, as a result of which the product was renamed an initiative.
NASWSI procedure
3 - 6 months before the target submission date, the applicant expresses its interest in the initiative using the Expression of Interest (EOI) form.
Early contact with the regulatory authorities is important for finding out whether the application qualifies for the initiative, for ease of planning and for coordinating the subsequent course of action.
The expression of interest form should be submitted 6 months in advance particularly if the fast-track authorisation procedure (FTP) is requested, or if a Presubmission Meeting is to be arranged.
Both the standard procedure and the fast-track authorisation procedure are available for the submission.
The same procedure must be applied for from all regulatory authorities, i.e. only the standard procedure or only FTP. Mixing of these two procedures is not possible.
For an FTP, a corresponding application must be submitted in advance to all regulatory authorities and approved. The process and decision for the fast-track authorisation procedure are separate for each authority.
Since the processes for the approval of an FTP differ for each authority, the applicant may need to observe additional lead times before submitting the dossier for work sharing purposes.
If different decisions are made, the applicant must decide whether to continue the procedure only with those regulatory authorities that have approved the FTP, or whether to submit the application to all regulatory authorities in the standard procedure.
The consent of all participating regulatory authorities is required for the work sharing option.
The regulatory authorities inform the applicant of their decision as soon as possible, normally within 6 weeks of receipt of the EOI.
At this point, the partner authorities also agree on which country takes the lead role and which module (3 to 5) is evaluated by which authority, and then inform the applicant of the most important milestones.
Throughout the procedure, the regulatory authorities communicate with the applicant in a coordinated manner.
The applicant submits identical dossiers (while taking country-specific aspects into account) to those authorities responsible for authorisation in the work sharing initiative.
Each submission must include the country-specific module 1 for the corresponding authority.
If the information in modules 2 to 5 differs between the individual regulatory authorities, the applicant must disclose this in the EOI form.
The dossier should, if possible, be submitted to the various authorities within a time frame of two weeks.
In certain cases, earlier submission of the application may be required for certain regulatory authorities since the formal control phases may differ.
Each authority reviews the module or modules 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. Modules will be peer reviewed by those participating authorities that have not conducted the respective main review. The authorities will then discuss the results in a teleconference and prepare a consolidated response to be communicated to the applicant.
The responsibility for checking modules 3, 4 and 5 can vary from application to application and is shared among the regulatory authorities on a case-by-case basis.
At the end of the procedure, each individual regulatory authority reaches its own independent decision (approval or rejection).
While a synchronised date for the official decision is sought, this may not be possible due to national processes.
Country-specific evaluation
The national guidelines should be consulted for information on the country-specific requirements. Some examples of scenarios requiring a country-specific review are listed below:
Application for FTP
Content of the labelling (e.g. wording of the indication, pregnancy section)
GMP
RMP
Stability
Time limits
The regulatory authorities try to reach their own country-specific decision within the agreed time limits listed below.
Standard procedure:
Day -45 to -30: Formal control
Day 1: Formal control completed
Day 120: List of questions
Day 150 or 180: Reply to List of Questions (applicant chooses between 30 and 60 days at the start)
Day 205 or 235: Preliminary decision
Day 220 or 250: Reply to preliminary decision
National phase (labelling)
Day 300: Official decision
Fast-track authorisation procedure:
Day -25: Formal control
Day 1: Formal control completed
Rolling questions
Day 130: Preliminary decision
Day 140: Reply to preliminary decision
National phase (labelling)
Day 180: Official decision
Advantages for industry
The advantages for the pharmaceutical industry are, in particular:
A less time-consuming procedure thanks to the submission of a joint dossier
Processing periods specified in advance
Shorter processing periods
Simultaneous market access in several countries
Opportunity to make a contribution to innovation in the area of regulation
Next steps
The ACSS NAS Working Group is actively exploring work-sharing options with the pharmaceutical industry. Applicants who are interested in taking part in this initiative are encouraged to submit the Expression of Interest form and/or contact the regulatory authority of their country:
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