Strategic Plan of "Access Consortium" published

Recommendation

20/21 February 2024
Munich, Germany

GMP meets Regulatory Affairs
Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective

The "Access Consortium", a consortium of the regulatory authorities from Australia (TGA), Canada (HBFB), Switzerland (Swissmedic), Singapore (HSA) and now also the United Kingdom (MHRA), published a three-year plan in the summer of 2021 regarding planned common approaches and goals.

This joint body has existed since 2007, initially under the name "ACSS". In 2020, the MHRA initially joined as a so-called "observer" and has been a full member of the consortium since January 2021. The international association of authorities is intended to support a uniform regulatory and more efficient approach and to strengthen cooperation in the area of approval.

The representatives of the authorities have now drawn up and published an "Access Strategic Plan". It lists the tasks and strategic goals of the consortium for the years 2021 to 2024 and also presents the challenges, also against the background of the Covid-19 pandemic.

The following points identify the three main goals of the plan:

• Strengths of the initiative:
  On the one hand, the submission of marketing authorizations via the "access" strategy is to be made even more attractive for marketing authorization holders; on the other hand, the resulting division of work among the authorities is to be strengthened.
  
  
• Expanding the lifecycle approach:
  The expansion of collaboration across the entire lifecycle of products is to be strengthened hereafter, focusing on the areas of clinical trials, risk management and pharmacovigilance.
  
  
• Innovative medicines/new technologies:
  According to this, regulatory capacities in the area of new technologies and innovative medicines are to be increased and international cooperation strengthened.

Here you can find the complete "Access Strategic Plan"  and further information on the "Access Consortium".