FDA seeks getting on the List of Third Countries with equivalent GMP Standards

The issue "Written Confirmations" is currently omnipresent. From 2 July on only APIs from countries outside the EU can be imported into the Union if a "Written Confirmation" is provided with the API. It is still not clear whether APIs without that "Written Confirmation" will be stopped at the boarder through customs or whether their use will just be prohibited for the manufacture of medicinal products. In any case, the pressure with regard to ensuring GMP compliance of APIs manufactured outside the EU has increased tremendously. Authorities from Non EU countries have to confirm by the "Written Confirmation" that the API has been manufactured according to EU GMP Part 2 (identical with ICH Q7) or according to at least equivalent standards. To find more information please see the Q&A Document on API Imports.

The only way to import an API into the EU without "Written Confirmation" is to get on the so-called list of third countries. To get on that list the EU Commission evaluates the equivalence of control standards in the respective country. So far, only Switzerland is on this list. Now the FDA has also filed a request for being evaluated. The authority does not mention in the press release whether they will also issue so-called "Written Confirmations" in the case they will not be listed until 2 July. However, it is very likely that the FDA's request will be answered positively.

The following countries have also forwarded a listing request: Israel, Australia, Singapore, Brazil and Japan. However, Israel's request has been rejected already. It is also unlikely that countries like India and China will forward a request as their GMP compliance standards are currently not equivalent with those in the EU. The only alternative for these countries is thus to supply "Written Confirmations" for every single API. There are currently severe doubts that this will be possible for all APIs imported into the EU. For that reason some pharmaceutical companies already started to increase their API stocks.

Source: FDA Website

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