GMP News - Pharmaceutical Development / Clinical Trials / GCP

Sponsors of EU clinical trials, where the QP is currently located in the UK, need to establish an EU-QP by the end of the transition period. In addition the sponsor of a clinical trial or a legal representative must be established in the EU. Read more here.

Regulatory authorities around the world want to work together more closely on the basis of Covid-19 and have identified three areas for this: research during pregnancy, medicines in clinical trials and monitoring of vaccines. Read more here.

GCP Inspectors from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US FDA have published a joint paper on data integrity in global clinical trials.

EMA´s Pharmacovigilance Inspectors Working Group adopted an new guideline on the follow-up activities of pharmacovigilance inspections.

Three drafts for new Ph. Eur. chapters on plastic packaging materials have been published for comment in the recent issue of Pharmeuropa: Cyclo-olefin polymers (COP), Cyclo-olefin copolymers (COC), and Extractable elements in plastic materials for pharmaceutical use.

The European Medicines Agency EMA has published three press releases on current EU/EMA activities in the context of the COVID-19 pandemic.

The FDA published a draft guideline "Transdermal and Topical Delivery Systems - Product Development and Quality Considerations".