MHRA joins Consortium of Regulators - without EU

Recommendation

Thursday, 17 December 2020 15.00 - 16.30 h

Webinar: GMP Update 2020/2021

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium.

The ACSS consortium was formed in 2007 and comprised the national regulatory authorities of Australia, Canada, Singapore and Switzerland. Now, after MHRA has joined, the group's name was changed to 'Access'. The MHRA will commence work-sharing applications with Access partners from 1 January 2021. The members aim to promote greater regulatory collaboration and alignment of regulatory requirements. In this context he Access Consortium explores opportunities for information and work-sharing in areas including:

• generic medicines registration
• assessment reports for new prescription medicines
• information sharing and investigations into post-market medicine safety
• alignment of IT systems for information sharing
• development of technical guidelines.