COVID-19 Vaccines, Tests and Therapeutics - Recommendations for Handling Emerging Virus Variants
The new variants of SARS-CoV-2 are now occupying the minds of scientists around the world. The FDA is responding with a series of updated guidelines and recommendations for developers and manufacturers of vaccine tests and therapeutics.
EMA Clarifies GMP Requirements for Herbal Substances Used as APIs
When does EU GMP Guide Part II apply to the manufacture of herbal extracts? A new EMA Q&A document on GMP for herbal extracts used as active substances in herbal medicinal products gives the answer to this question.
EMA: Revised Q&A Document for Centralised Procedures
The "Q&A" document for centralised marketing authorisation procedures, focusing on questions and answers on topics that marketing authorisation holders should consider after obtaining a marketing authorisation, was revised again and published on the EMA website in February.
Updated Guidance on the Management of Clinical Trials during COVID-19
Pragmatic procedures are currently required to ensure the flexibility needed to maintain the integrity of clinical trials during the COVID-19 pandemic. The updated guidance on management of clinical trials during COVID-19 includes adapted approaches for IMP supply and details on remote source data verification.
EMA: Updated Q&A documents on Centralised Procedures
The "Q&A" documents for centralised procedures were revised and published on the EMA website in January. In general, pre- and post-approval advices regarding centralised procedures are given and specially information for applicants of generic or hybrid medicinal products is mentioned.
Due to the great public interest and the varied discussions, EMA organises a public meeting on Covid-19 vaccines and the role of EMA in the approval process, which all interested citizens can attend via live broadcast.