MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit

In the event of a no-deal Brexit, reference medicinal products (RMP) for new generic medicines or abridged marketing authorisation applications will be required to comply with the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs). Comparator products (CP) used in these applications will need to be representative of the RMP. Read more “MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit”

The MHRA have published new guidance on Paediatric Investigation Plans (PIP), requests for waivers, deferrals and compliance in the event of a no-deal Brexit

The new guideline outlines the required format and content of applications for agreement or modification of a Paediatric Investigation Plan (PIP) and requests for waivers or deferrals. Read more “The MHRA have published new guidance on Paediatric Investigation Plans (PIP), requests for waivers, deferrals and compliance in the event of a no-deal Brexit”

Are you aware of the Department of Health and Social Care’s (DHSC) work with the industry on plans to minimise any medical supply disruption following a no-deal Brexit?

The Medicines and Healthcare Regulatory Agency (MHRA) have released guidance summarising their approach and actions to be taken by businesses supplying the United Kingdom (UK) with medicines from the European Union (EU), Iceland, Lichtenstein or Norway. Read more “Are you aware of the Department of Health and Social Care’s (DHSC) work with the industry on plans to minimise any medical supply disruption following a no-deal Brexit?”

How will the MHRA regulate biological medicines including biosimilars, ATMPs and PMFs in the event of a no-deal Brexit?

The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their guidance which outlines the procedures that the MHRA plan to introduce to regulate biological medicines in the event of a no-deal Brexit. The guidance covers United Kingdom (UK) marketing authorisation for biosimilars, marketing authorisation applications for advanced therapy medicinal products (ATMPs) and plasma master files (PMF) post Brexit. Read more “How will the MHRA regulate biological medicines including biosimilars, ATMPs and PMFs in the event of a no-deal Brexit?”