UK MHRA To Have Its Say Again In ICH Activities
Executive Summary
The UK drug regulator has rejoined the International Council for Harmonisation as a fully active member with voting rights.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has become a member of the International Council for Harmonisation and has regained the voice it had in the ICH before Brexit, when it was a member as part of the EU delegation.
The agency, which lost its ICH membership after the UK left the EU, will again be able to actively participate in the council’s activities and will now also have voting rights.
Formed in 1990, the ICH works on harmonizing the requirements for the development and registration of pharmaceuticals globally via a process of scientific consensus with regulatory and industry experts working side by side.
As a member, the MHRA will have a say in the guidelines the council develops to help ensure the quality, safety and efficacy of medicines worldwide.
Its membership was announced during last month’s ICH Assembly hybrid meeting in Athens, Greece, according to a statement released last week by the council.
Before becoming a member in its own right, the MHRA joined the ICH as an observer in June 2021 and applied for membership using an expedited procedure that the ICH adopted in November 2020. This fast-track mechanism enables regulatory authorities who have become ICH observers to submit an application for membership in an expedited manner, provided they have attended one assembly meeting and have implemented at least 75% of ICH guidelines. (Also see "UK Regulator Eyes Expedited Process For Securing Full ICH Membership" - Pink Sheet, 21 Jun, 2021.)
Achieving membership will give the agency the opportunity to have its say on the technical and policy environment of the future, according to the ICH. All members participate in the consensus-building and decision-making in the ICH Assembly. They can also propose new topics, participate in the selection of topics for harmonization, and nominate technical experts to contribute to current harmonization activities. Where consensus cannot be reached, the regulatory members of the council have the right to vote on items such as the endorsement of draft ICH guidelines and the adoption of final ICH guidelines.
The ICH now has a total of 20 members, which include, among others, regulators from Brazil, China, the EU, Japan and the US, and industry associations.
It also has a total of 35 observers, with the newest one, Algeria’s National Agency for Pharmaceutical Products (ANPP), also announced during the ICH Assembly meeting.