From 2 July 2013 on, APIs from Third Countries will be allowed for importation into the European Union only if the regulatory authority of the exporting country is confirming that the API was manufactured according EU GMP. Currently, hardly any other subject is as extensively discussed in the GMP environment as this so called Written Confirmation.
To find out how this issue is handled in pharmaceutical companies in the EU, the European QP Association conducted a brief survey amongst its members beginning of this year. Almost 300 QPs gave answers to the questions. This is an impressive number which also means that the results are quite representative.
At the time of the survey almost 50% of the companies replied that they had already tried to get a written confirmation for APIs manufactured outside the EU. Only 15% were confident that their company will get the written confirmation for all APIs imported from outside the EU by 2 July 2013. 35% didn't think so. For the rest it was too early to say at this stage.
Another question asked was who is or will be appointed in the company to assure that APIs imported from countries outside the EU are accompanied by the Written Confirmation. It was very interesting to see that in more than 40% of the companies the Qualified Person (QP) will be directly involved in this process. With about the same percentage, Quality Assurance functions will be in the driver seat in other companies; and procurement only in 22% of the companies:
The QP Association also asked about strategies dealing with possible problems caused by missing written confirmations. It seemed that here was not much consensus on how to deal with these possible challenges:
There is still a lot of uncertainty in Europe what the future will bring. An alternative to a Written Confirmation is the admission to the list of "Third Countries" with comparable inspection standards. Currently only Switzerland is on that list and therefore does not have to issue Written Confirmations. Israel and also Singnapore's request have been rejected (see ECA News from 20 March 2013). It is 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. Exceptionally and where this is necessary to ensure the availability of medicines, the need for the written confirmation can be waived by a Member State if a Member State has inspected the plant and found it compliant (Directive 2001/83/EC Article 46b, 4).