Manufacturing roundup: FDA, Swissmedic ink deal on pharma GMP; SK biotech contracts with Charles River for RNA therapy
The regulatory agencies of the US and Switzerland signed an agreement last week, allowing them to utilize each other’s good manufacturing practice (GMP) inspections of pharmaceutical manufacturing facilities — and bypass duplicate inspections.
This is the newest agreement that the FDA has with foreign entities, such as the EU and the UK. These agreements are thanks to a 2012 law that allowed the FDA to recognize inspections conducted by certain foreign regulators determined to be capable of inspections that met US requirements.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.