WHO joins international collaboration on GMP inspection of API manufacturers, membership criteria established
This article was originally published in SRA
The World Health Organization has joined the ongoing international collaboration between EU, US and Australian drug regulators on good manufacturing practice inspections of active substance manufacturers1. In addition, clear criteria have been established for new participants to be accepted onto the programme and also to maintain consistent standards among existing participants2.
You may also be interested in...
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.