RE:EU Legislative proposals aims to expedite new medicinesIn addition to the EU's adoption of the new medicines proposals April 11, 2024, - on February 27, 2023, the UK government and the European Commission announced a political agreement in principle to replace the Northern Ireland Protocol with a new set of arrangements, the Windsor Framework. This new framework fundamentally changes the existing system under the Northern Ireland Protocol, including the regulation of medicines in the UK. In particular, the MHRA will be responsible for approving all medicines destined for the UK market (that is, Great Britain and Northern Ireland), and the European Medicines Agency (EMA) will no longer have a role in approving medicines destined for Northern Ireland. The MHRA will grant a single UK-wide marketing authorization for all medicinal products sold in the UK, enabling medicines to be sold in a single pack and under a single authorization throughout the UK. The Windsor Framework was approved by the EU-UK Joint Committee on March 24, 2023, meaning the UK government and the EU will enact legislative measures to bring it into law.
Furthemore, implementation of the International Recognition Procedure (IRP), effective January 1, 2024, in the UK, which replaces the European Commission Decision Reliance Procedure, allows the MHRA to consider the expertise and decision-making of medicines regulators in Australia, Canada, the EU, Japan, Singapore, Switzerland, and the US when approving a new medicine. The decentralized and mutual recognition reliance procedure (MRDCRP), which allows the MHRA to have regard for approvals in the EU, will be incorporated under the umbrella of the IRP.
This collaborated effort to reduce international "red-tape" and facilitate collective international regulatory decision-making for the approval of new medicines that treat orphan diseases and those with 'unmet treatment needs", further helps advance the expedited approval of new medicines like ONCY's pelareorep in the United States, the UK, and the European Union.