Surveillance of Medicinal Products- Annual Report of the German Federal States

In February, the German Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) published in February its annual report on the surveillance of Medicinal Products for 2009. Although the data were recorded more than a year ago, the report gives a compact and global overview of the current state of inspections. The contents of the report not only aim at informing the professional public but also the Member States as well as the MRA partners. The data inform about the development and the results of the activities of the German inspectorates. Besides, the statistical part contains data about manufacturing sites, inspections and certificates issued. Inspections of pharmacies and of clinical trials is not taken into consideration here. 

Number of manufacturing sites

  • In 2009, 2.189 manufacture and/or import authorisations were listed. 90.5% of the manufacture authorisations applied to human medicines and 9.5% to veterinary products.
  • In Germany, the manufacture of APIs from human, animal or microbial origin and genetically-modified as well as certain substances from human origin used for the manufacture of medicinal products are subject to authorisation. At the time of the reporting, there were 148 manufacturers located in Germany.
  • 370 testing sites/ laboratories were listed.

Number of inspections conducted in Germany

  • In 2009, the inspectorates conducted 1.518 inspections. Most of them were carried out at manufacturers, importers and wholesalers. These are 92 inspections more than the year before.

International activities

  • As in the previous years, continuously increasing requests from foreign authorities (especially from the EMA and MRA partners like Canada and Australia) on globally operating headquartered in Germany were recorded. 
  • The German Medicines Law (AMG) requires control over the import of medicinal products and certain APIs from outside the EU. Moreover, the inspectorates perform GMP inspections - based on the central authorisation procedure - when the holder of an import authorisation is headquartered in Germany. In 2009, the inspectorates carried out in total 133 inspections in third countries. One out of 11 GMP inspections took place in a third country. In total, 631 GMP certificates were issued. 
  • Altogether, we can notice that the manufacture of APIs and medicinal products is more and more migrating to third countries. We can therefore suppose that the number of inspections carried out in third countries - which has already been high over the last years - according to § 72a AMG will keep on increasing with a focus on GMP Compliance of API manufacturers.

Source: Annual Report of the Federal States (in German)

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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