Regulatory

UK MHRA is all set to join regulatory consortium post-Brexit

United Kingdom has planned to join Australia, Canada, Singapore and Switzerland in a regulatory consortium after it separates from the EU (post-Brexit) possibly during the inception of next year, hence enabling companies to access all five markets through a single application. MHRA will commence its working in the group from 1st January, 2021 and this group will be known as Access Consortium.

Due to Brexit there was concern for delay in the access of new medicines for UK patients. But UK-MHRA has responded to the concerns by joining the Australia-Canada-Singapore-Switzerland Consortium. Motto of this consortium is to provide timely access and high quality medicines with highest possible safety and efficacy to those countries covering round 145 million people. The pharmaceutical industries willing to apply for to any of the above countries or all the countries will get the benefits of getting their application reviewed simultaneously in all the countries within minimal evaluation time.

After this collaboration MHRA will be a full Access member to take part in such cooperative assessments and also for the other activities. Due to this joining UK MHRA will have the responsibilities of reviewing the submissions, as it did earlier with other EU regulators, and thus enhance access of certain medicines for UK market. This could enhance the use of the initiatives, particularly in the case of Australia-Canada-Singapore-Switzerland Consortium (ACSS). This involvement will ultimately increase the market viability as the population of UK itself is as large as the total population of all the 4 countries combined.

For more detail please refer below link:

https://www.gov.uk/government/news/uk-medicines-regulator-joins-up-with-australia-canada-singapore-and-switzerland-regulators

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