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New year, new standards for investigational medicines

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice

New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European Union, and with it, the Commission guidelines on good manufacturing practice for investigational medicinal products for human …

Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1) – our initial response

Posted by: , , and , Posted on: - Categories: Good clinical practice, Inside the Inspectorate
Illustration Of A Team Of Scientists Working On Coronavirus Vaccine In The Laboratory

The Covid-19 pandemic has been a challenging time for all of us and in this three-part blog series, we reflect on what we have learnt and how we move forward to implement those learnings for the benefit of the UK …

Public Consultation on new Clinical Trials Legislation

Posted by: and , Posted on: - Categories: Events and symposia, Good clinical practice

The MHRA has launched an  8-week public consultation on proposals for legislative changes for clinical trials. Following the UK’s exit from the European Union, the Medicines and Medical Devices Act allows us the opportunity to update our current legislation in relation …

Pharmacovigilance Inspection Metrics April 2020 to March 2021

Posted by: , Posted on: - Categories: Compliance matters, Good pharmacovigilance practice
analysing data with a magnifying glass

The MHRA GPvP Inspection Metrics report for the period April 2020 to March 2021 is now available. Read the full metrics report published on GOV.UK. We hope that the report is informative and useful for considering compliance and improvements within …

Too good to be true? How to play your part in protecting the UK medicines supply chain (updated)

Posted by: , Posted on: - Categories: Compliance matters, Events and symposia, Good distribution practice

The MHRA is inviting you to attend a free webinar as part of its commitment to providing guidance to industry and supporting stakeholders to prevent falsified medicines entering the legal supply chain.