Recognition of the FAMHP by the American Food and Drug Administration (FDA)

date: 03/12/2018

The American Food and Drug Administration (FDA) has recognised the FAMHP as its Belgian counterpart under the mutual recognition agreement (MRA) between the European Union and the United States.

The mutual recognition agreement (MRA) concluded on 16 November 2018 between the European Union (EU) and the United States (USA) offers the EU and the USA:

  • mutual recognition of inspection systems,
  • information sharing on inspections carried out by the parties and on any quality defects identified in the different countries,
  • the removal of the need to perform a full analysis of imported products.

Commercial medicinal products for human use that fall under the MRA are as follows:

  • Medicinal products of chemical origin, including gases and radiopharmaceuticals;
  • Medicinal products of biological origin, excluding vaccinations;
  • Homoeopathic medicinal products, herbal medicines, vitamins and minerals if they are classed as medicinal products in their country of origin;
  • Active pharmaceutical substances;
  • Unfinished products and intermediary manufacturing products.

Amongst other things, an agreement of this type reduces the number of redundant inspections carried out in the signatory countries of the MRA. Under certain circumstances, the signatories may still carry out inspections, for example, in the case of products intended for only one of the markets, or in the case where an inspection can only be carried out by one of the parties.

There are number of benefits to an MRA, especially regarding the time saved that allows the countries concerned to dedicate more time to inspections in other areas, such as products subject to clinical trials.

Where Belgium is concerned, the MRA takes effect retroactively: Belgian inspection reports have been recognised by the USA since 9 August 2018.

An MRA agreement can also cut production costs for the pharmaceutical industry thanks to the reduction in the number of inspections and the removal of the obligation to re-analyse imported medicinal products.

More information can be found on the EMA’s website.

Last updated on 03/12/2018