New Information on Written Confirmation from the EU Commission

Hardly any other subject is as extensively discussed in the GMP environment as the so called Written Confirmations (confirming the GMP compliance of an API / of the API manufacturer). Starting from 02 July 2013, all APIs manufactured outside the EU have to be accompanied by a Written Confirmation, otherwise they cannot be imported into the EU. Many countries outside the EU have not yet commented yet whether - and if yes, when - Written Confirmation will be issued. Therefore there is a risk that single APIs will not be available any more after 2 July.

The only alternative to a Written (GMP) Confirmation is the admission to the list of "Third Countries" with comparable inspection standards. Currently only Switzerland is on that list and therefore has not to issue Written Confirmations. It now became public that following Israel's request also Signapor's request has been rejected - as Singapor does not conduct binding GMP inspections for API manufacturers (only voluntary inspections upon request). There has not been a decision with regard to the requests from Japan, USA, Brazil and Australia.

India continues to prepare to issue Written Confirmations on time on 2 July. The Indian authority has now published a respective announcement on their website. A new instruction on Written Confirmations describes how the Indian authority will specifically proceed. They even issued a comprehensive GMP Checklist (29 pages). According to the Indian authority this checklist is based on the WHO GMP requirements for APIs as well as on the ICH requirements. However, it refers to the ICH Q9 Guide (Risk Management) - and not to Q7 GMP for APIs). Also, the checklist has a column in which API manufacturers can provide information with regard to GMP compliance themselves. To what extent the Indian authority also issues Written Confirmations solely based on information provided by the API manufacturer is not known. The description of the process currently plans an inspection already 15 days after the request of the API manufacturer. In the light of the large number of API manufacturers in India (only in China there are more API manufacturer exporting to the EU) this time frame seems to be very optimistic.

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