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 worldwide work more closely together because of COVID-19
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.
Impact of COVID-19 on EudraVigilance Reporting and Labeling
The European Commission, the HMA and the EMA released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document includes flexible approaches for adverse reactions reporting and labeling.
Update on COC / COP and Extractable Elements in Plastic Materials
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.