With 01 November, the EU-FDA Mutual Recognition Agreement (MRA) of GMP inspections of human manufacturers came into operation. It started with the recognition of the US Food and Drug Administration (FDA) and the first eight EU Member States: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. On 01 March 2018, the FDA confirmed the capability of four more EU Member States to carry out GMP inspections at a level equivalent to the FDA: Czech Republic, Greece, Hungary and Romania.
This group of now twelve authorities may still look small, but this is based on the date when each of the authorities was assessed. It does not necessarily mean that other countries failed the process. Other EU member states will be added as their evaluation is completed by the US. According to the EMA press release, "Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track."
What about the removal of the importation testing requirement? Will testing continue to be required on importation into some Member States and not others reflecting accession timelines? This is something EU companies and Qualified Persons should certainly be aware of. There is a statement in Article 19 "Entry into force": "Notwithstanding paragraph 1, Article 9 [Batch testing] of this Annex shall not apply until the date on which all the EU Member State authorities for human pharmaceuticals listed in Appendix 2 have been recognized by the FDA." So import testing needs to be performed until all Member States have been found equivalent and the MRA is fully in operation. Then, the Qualified Person will be relieved of the responsibility for carrying out the controls laid down in Article 51 paragraph 1 of Directive 2001/83/EC and in Article 55 paragraph 1 of Directive 2001/82/EC with the following provisions:
- The product was manufactured in the United States
- The respective controls have been carried out in the United States
- Each batch is accompanied by a batch certificate (in alignment with the WHO certification scheme), issued by the manufacturer certifying that the product complies with requirements of the marketing authorisation and signed by the person responsible for releasing the batch
Please find the details in the EMA press release entitled "Four more EU Member States benefit from EU-US mutual recognition agreement for inspections".