Are 300 GMP Inspections necessary by 2 July 2013?

The heads of the EU authorities for medicines are organised in a Top Level Committee. The so-called Head of Medicines Agencies (HMA) meets regularly to discuss current regulatory developments.

Both the authorities and the industry are equally engaged in current developments with regard to import of APIs to the EU. As of 2 July 2013 each consignment of APIs to Europe must be accompanied by a Written Confirmation from the exporting country. Only countries which are listed on the list of "third countries" with equivalent inspection systems don't need to issue a Written Confirmation. At the moment, Switzerland is the only country on the list. For more information please read our GMP News on APIs import from China and India as well as our GMP News on Written Confirmations.

In December 2012, the HMA expressed serious concerns about the implementation of the new requirements in a statement which can be found on the HMA webpage. HMA representatives say: "This situation might endanger public health within the EU due to possible shortages of medicinal products for the European market and consequently become a serious public health risk."

The concerns were firmed up during a meeting which took place on 30/31 January 2013 in Dublin. A database has been established in the course of a survey of each EU authority which should indicate which API manufacturer should be inspected by the 2nd of July. These inspections are necessary to ensure the delivery into the EU as the API manufacturers concerned may have not received the Written Confirmation from their authority and the countries of orign aren't on the "third countries" list. According to the current information 300 sites are concerned by the inspection. The HMA's protocol shows that the resources available in the EU countries would enable the performance of 25 inspections only by the end of June 2013.

It is impossible to predict whether this will lead to supply shortage from 2 July on. As a precautionary measure, many pharmaceutical manufacturers are currently increasing their stocks of APIs from non-EU countries.

Source: HMA Press Release