![]() The MHRA notes “ hrough this new dual approach, we will contribute to the UK’s ambition to be a global science superpower, by making the UK one of the best places in the world to bring life-changing healthcare products to patients safely.” This includes the MHRA’s own Innovative Licensing and Access Pathway. The announcement highlights that this route will sit alongside the MHRA’s other routes for approval. ![]() Therefore, even if another regulator has approved a medicinal product, the MHRA retains the authority to reject an application if it does not consider it sufficiently robust. From Q1 of 2024 the MHRA intends to recognize approvals of medicinal products from:Īs for all other MAs granted in the UK, the MHRA will still remain the sovereign regulator and will remain responsible for approving all applications under the recognition route. The MHRA’s May announcement sets out its plans for this new route. It would also provide funding to the MHRA to implement this route (discussed in on previous blog here). In its Spring Budget, the UK Government said it intended to introduce a new international reliance route. How will the New International Reliance Route work? They are due to expire at the end of 2023. However, these routes are only temporary.
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