US FDA recognises GMP inspections from Belgian Federal Agency for Medicines and Health Products

Kaat Van Delm

In November 2018, the FDA recognised the Belgian FAMHP as being capable of carrying out good manufacturing practice (GMP) inspections at a level equivalent to those in the United States.
On 1 March 2017, the European Union and the U.S. agreed to amend the Mutual Recognition Agreement from 1998, with regard to the “Sectoral Annex on Pharmaceutical GMPs” (MRA Amendment). In this MRA Amendment, the European Commission and FDA agree to mutually recognise the inspections of manufacturing sites where human medicines are manufactured.
Advantages of the MRA Amendment include the facilitation of:

  • the exchange of official GMP inspection documents between the EU and US
  • trade, by avoiding duplication of inspections
  • the oversight of manufacturing facilities, and
  • prevention of adverse health consequences

Even though the MRA has been in force since November 2017, it is in transition until July 2019. In the meantime, the parties need to recognise the various regulatory authorities for medicinal products for human use, in accordance with a timeline set out in the MRA Amendment. The first authorities (including the FDA and the authorities from 8 EU countries including the UK, France and Austria) were recognised on 1 November 2017 and the process is still on-going (the current list of recognised authorities is available on the FDA website). The MRA Amendment will terminate on 15 July 2019, in the event that the FDA by that date has not completed recognition of each EU authority.

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