The UK Medicines and Healthcare products Regulatory Agency (MHRA) has rejoined the International Council for Harmonisation (ICH) Assembly as a member, giving it a full say in the activities of the organization for the first time since Brexit.
Before Brexit, MHRA participated in ICH activities as part of the EU delegation, enabling it to sit on working groups and influence international standards. Leaving the EU forced the UK to reapply, initially as an observer. ICH admitted the UK regulator as an observer last summer. Traditionally, observers have needed to attend three out of four consecutive biannual ICH meetings to achieve full membership.
ICH adopted an expedited process for regulatory authorities that have implemented at least 75% of its guidelines in 2020, offering MHRA a shorter path to membership. MHRA has now completed the process, leading ICH to accept the agency as a new member. The change allows MHRA to resume contributing to and voting on ICH activities.
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