Drugs

Swiss-FDA Mutual Recognition Agreement

FDA has signed an Agreement on Mutual Recognition between the Swiss Confederation and the U.S. relating to pharmaceutical good manufacturing practice. A 1/12 notice to international colleagues says FDA and the Swiss Agency for Therapeutic Products will be able to use each other’s good manufacturing practice inspections of drug manufacturing facilities, avoiding the need for duplicate inspections.

FDA already has mutual recognition agreements in place with the European Union and the UK.

The notice says the FDA Office of Global Policy and Strategy has been negotiating the agreement with Switzerland for several years. Before the agreement enters into force, it says, FDA must determine whether Swissmedic is capable of inspections that meet U.S. requirements, and Swissmedic must make a similar determination on FDA meeting Swiss requirements.

In addition to covering good manufacturing practice inspections at facilities manufacturing human drugs, the agreement also includes facilities manufacturing veterinary drugs.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome