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Good clinical practice

ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation

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The International Council for Harmonisation (ICH) Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) Good Clinical Practice (GCP) guideline. The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2). These …

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). …

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

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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 …

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

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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

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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 …