On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the Official Journal of the EU: “Decision No 1/2017 of 1 March 2017 of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending the Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)” (the “Agreement“).

The Agreement is a Sectoral Annex to the general EU-US Agreement on Mutual Recognition in relation to conformity assessment of regulated products, signed in 1998. Mutual recognition in the area of GMP for medicinal products was not implemented prior to the Agreement.

On the basis of the Agreement, EU and US regulatory authorities will be able to rely on each other’s activities in relation to facilities in the EU or US that manufacture human medicinal products and active pharmaceutical ingredients for the EU and US markets. The scope of the Agreement includes:

  • Reciprocal recognition of GMP inspections and document thereof (Article 8);
  • Transmission of post-approval official GMPs document (Article 10);
  • Requests for the conduct of a pre-approval or post-approval inspection of a manufacturing facility (Article 11).

The mutual recognition of the activities governed by Article 8, 10 and 11 will apply from 1 of November 2017.

Article 9 also provides that the scope of the Agreement includes the waiver of requirements for batch testing of products on entry into the EU and US territories, after a transition phase.

The transition phase will last until the US and the EU conclude reciprocal assessment of the competent regulatory authorities. The assessment is governed by Appendix 4, Section II to the Agreement and consists in the evaluation of the regulatory and procedural frameworks for inspections of manufacturers of medicinal products for human use.

The Agreement provides that the EU shall complete an assessment of the FDA for human pharmaceuticals no later than 1 July 2017. The FDA shall complete the assessment of at least eight EU Member State authorities by November 1, 2017. The FDA’s assessment is expected to gradually be expanded to cover all EU Member States’ authorities by July 15, 2019.

Imported products will still need to be batch tested on entry into the EU and US territories until this requirement is waived after the transition phase.

One of the expected outcomes of the reciprocal recognition of the FDA and the EU Member States’ activities identified by the European Commission is the reduction of the administrative burdens and inspection-related costs facing pharmaceutical manufacturers.