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Manufacture of Investigational Medicinal Products – Frequently Asked Questions

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accurately measuring ingredients into a petri dish

GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder queries which relate to the manufacture, import, labelling, licencing requirements and general handling of Investigational Medicinal Products (IMPs). …

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 …