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”

How to submit ICSRs and SUSARs to the MHRA if the UK leaves the EU with no-deal

The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance for all pharmaceutical companies involved in the submission of Individual Case Safety Reports (ICSRs) or Suspected Unexpected Serious Adverse Reactions (SUSARs) in the event of a no-deal Brexit. Read more “How to submit ICSRs and SUSARs to the MHRA if the UK leaves the EU with no-deal”

Making submissions to the MHRA if the UK leaves the EU without a deal

The Medicines and Healthcare Products Regulatory Agency (MHRA) are making preparations to ensure that if the United Kingdom (UK) does leave the European Union (EU) with no deal, companies can continue to submit regulatory and notification information to the UK. Currently the only areas enabled on the MHRA Submissions home page are the User Maintenance and Pharmacovigilance Gateway Management. Read more “Making submissions to the MHRA if the UK leaves the EU without a deal”

EMA provides procedural update on submission of Type 1 variations in March, April and May 2019

The European Medicines Agency (EMA) is encouraging Marketing Authorisation Holders (MAHs) who intend to submit Brexit-related Type IA and Type IB variations in March 2019, to submit these variations as soon as possible during the month. This will ensure that the EMA can process the submissions before 29th March, so that MAHs can receive confirmation of compliance with the regulatory and legal requirements before the United Kingdom (UK) leaves the European Union (EU). Read more “EMA provides procedural update on submission of Type 1 variations in March, April and May 2019”