Working Group Summaries
The Generic Medicines Working Group (GMWG)
The Generic Medicines Working Group (GMWG) has been active since 2012 and is one of the more established and advanced initiatives under the Access umbrella. This group is creating opportunities and benefits for regulatory programmes through:
- greater alignment of regulatory approaches and technical requirements,
- efficient use of resources through information and work sharing, and
- establishment of an effective network among trusted, like-minded regulatory authorities.
The New Active Substances Working Group (NASWG)
The New Active Substances Working Group (NASWG) coordinates the New Active Substance work-sharing initiative. This unique global collaboration involves the joint review of innovative medicines including new chemical entity or new biological entity applications, or new indication applications.
This initiative continues to foster cooperation and strong relationships between its Access partners.
Advanced therapy medicinal products working group (ATMPWG)
In 2023, the Access Consortium established a working group for advanced therapy medicinal products (ATMPs). ATMP is a term used in the legislative framework implemented by the European Union to regulate cell therapies, gene therapies and tissue engineering products.
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
Information Technology (IT) Working Group (ITWG)
The objective of the Information Technology (IT) Working Group's priorities are to establish a secure platform for the exchange of confidential business information and share information on IT architecture, planned activities and ongoing projects.
Clinical Trials Working Group
The Clinical Trials Working Group was established to enable the member authorities to exchange regulatory information on a case-by-case basis for clinical trials of interest to Access countries, as well as to establish consensus agreement on general considerations for clinical trials.