Access Consortium

Generic Medicines Working Group (GMWG)

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):

Meetings and Communications

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 to at least two members of the Access 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

The procedure is described in the “Operational Procedures” document.

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 Fast Track Procedure (Priority pathway)(Guidance document Fast track authorisation procedure)
  
• Content of the labelling (e.g. wording of the indication, pregnancy section) (Guidance document Product information for human medicinal products)
  
• GMP (Guidance document GMP compliance for foreign manufacturers)
  
• RMP (Guidance document RMP ICH E2E information submission)
  

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

Expression of interest

The Access 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:

• Australia: streamlinedsubmission@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

Expression of Interest (EOI) Form

Access consortium work sharing authorisations

Applications that have successfully received market approval through the Access Consortium “New Active Substance Work Sharing Initiative” (NASWSI) in Switzerland:

The Biosimilar Working Group (BSWG) has been set up to harmonise regulatory approaches and technical requirements in such a way that they open new regulatory options for biosimilars. This led to the launch of a work sharing pilot project.

Biosimilar Work Sharing Initiative (BSWSI)
Work sharing is suitable for companies that submit an authorisation application for a biosimilar in at least two members of the Access Consortium.

BSWSI procedure
The BSWSI follows essentially the same procedure as NASWSI (see title: New Active Substance (NAS) Working Group). Please note, however, that the priority review pathway is only applicable for the NASWSI. An outline of the key information for industry in filing a work sharing submission for a biosimilar can be found here:

The applicant should first express interest in the initiative by sending the

to the relevant authorities. This should be done at least 3 months before the intended filing date. The EOI for Switzerland should be send to Access@swissmedic.ch, and the subject line should contain “Access Consortium – Biosimilars Work Sharing”.