Manufacturing
New mutual recognition agreements: EU-US for veterinary medicines and the MHRA...
In today's EU-US Trade and Technology Council, the US and the EU reached an agreement to mutually recognise the results of pharmaceutical Good Manufacturing Practices (GMP) inspections for veterinary products. The new international recognition routes will sit alongside the MHRA’s own unique innovation pathway for medicines which integrates early regulatory advice with health technology assessment advice
FDA, a discussion paper on the use of AI
The FDA’s “Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments” was open to comments until 1 May 2023. It aims to address areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts associated with application of artificial intelligence (AI) to pharmaceutical manufacturing
R&D
EU Parliament, a study on investments for Covid-19 Vaccines
A study prepared for the special COVI committee of the European Parliament shares light on how the great amount of funds for the development of Covid-19 vaccines was used for R&D and the expansion of the production capacity. Nine different vaccines have been examined, and comparisons have been also made with the US situation
EMA, consultation on single-arm clinical studies
A new reflection paper and a consultation open up to 30 September 2023 will pave the way to the drafting of a new guideline on single-arm clinical trials submitted to EMA as pivotal evidence in support of marketing authorisation (MA) applications
