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MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use

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Several companies have contacted the MHRA regarding cannabis-based products for medicinal use. This blog provides information on what authorisations are required in order to manufacture within this sector of the pharmaceutical industry. For an overview of unlicensed Cannabis-Based Products for …

Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward

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Illustration Of A Team Of Scientists Working On Coronavirus Vaccine In The Laboratory

In parts one and two of this series, we looked at how we responded to the unprecedented challenges the COVID-19 pandemic and the lessons we have learned. In this final part, we explore the challenges ahead. Remote access to EHRs …

Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learned

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

In part one of this series, we explored as an introduction how we initially responded to the Covid-19 pandemic to move faster in the set-up and approval of clinical trials. Now we look at the unprecedented challenges we faced in …

New year, new standards for investigational medicines

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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 …