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?”

MHRA updates guidance on substantial amendments to a clinical trial if there is a no-deal Brexit

The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their no-deal Brexit guidance which covers significant amendments to a clinical trial. This includes changes to the trial sponsor/legal representative, investigational medicinal product (IMP) certification and importation and amendments to the Research Ethics Committee (REC). Read more “MHRA updates guidance on substantial amendments to a clinical trial if there is a no-deal Brexit”

European Commission outlines the impact of Brexit on Good Laboratory Practice

From 1st November 2019, it is likely that the United Kingdom (UK) will no longer be a member of the European Union (EU). The European Commission has outlined the consequences of how EU rules in the field of Good Laboratory Practice (GLP) will no longer apply to the UK after Brexit, however an EU-wide “Mutual Acceptance of Data” (MAD) system will apply. Read more “European Commission outlines the impact of Brexit on Good Laboratory Practice”

EMA provides update on Brexit in their March 2019 Management Board meeting

Following the agreement between the United Kingdom (UK) and the European Union (EU) to extend the Brexit deadline, during the European Medicines Agency’s (EMA) Management Board meeting in Amsterdam they stated that the prospect for centrally authorised products to be at risk of shortage “continues to decrease”. However, the agency has warned that if the UK were to leave the EU with no-deal, then there is still a high risk of supply issues with some medicines. Read more “EMA provides update on Brexit in their March 2019 Management Board meeting”

How to register clinical trials for investigational medicinal products and publish trial results if the UK leaves the EU with no-deal

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released guidance about registering clinical trials, publishing trial results and future requirements if the United Kingdom (UK) leaves the European Union (EU) without a deal. The guidance will apply from exit day subject to the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019 being passed. The guidance will only apply in the event of ‘no-deal’ scenario. Read more “How to register clinical trials for investigational medicinal products and publish trial results if the UK leaves the EU with no-deal”