Annual report 2009 of the Danish Medicines Agency's laboratory control activities

14 June 2010

The medical authorities in Europe cooperate in a network called the Official Medicines Control Laboratories (OMCL). The Danish Medicines Agency has published an annual report for 2009 that describes the activities of the Agency to the OMCL network.

European laboratory cooperation in OMCL

The purpose of OMCL is to exchange knowledge and experience and to promote the elaboration of new common standards within the area of laboratory control of medicinal products. You can read more about the OMCL network in the factbox to the right.

Annual report 2009 of the Danish Medicines Agency's laboratory control activities

You can download the full report on our activities in the factbox to the right. We have extracted some of the highlights from the report below:

  • Test of nationally authorised medicinal products: In 2009, the laboratory tested a total of 300 nationally authorised medicinal products. None of these tests resulted in products being withdrawn from the Danish market, but a significant share of the tests (57 %) caused us to discuss matters concerning labelling and SOPs as well as specifications and stability issues with the manufacturer.

  • Shortage of radiopharmaceuticals in 2008/2009 and into 2010: Since the summer of 2008, there has been periodic reductions in and shortages of Mo99 and of technetium Tc99 generators throughout the world. Since Technetium Tc99 is used for most nuclear medicine diagnostic applications, the shortages have had and still have a serious impact on patients’ access to radiopharmaceutical products.

  • Focus on rule compliance of API manufacturers: We have completed a project that focuses on the finished product manufacturers’ ability to ensure that the active pharmaceutical ingredients (APIs) that they use in their products are manufactured according to good manufacturing practice (GMP). The results of the project have been published in a report on our website.

  • Focus on sterility in 2009: The Laboratory started the project to investigate whether changes in the Pharmacopoeia monograph 2.6.1 Sterility had been implemented. The project also examined the extent of ‘parametric release’. The results showed that 20 % had not implemented the monograph changes and that the extent of ”parametric release” is modest.

  • Evaluation of the labelling and packaging material of medicinal products: In 2009, we processed a number of cases concerning problems with the labelling and packaging material of medicinal products. Several cases have resulted in changes to labelling and packaging material, thereby improving patient safety.

  • Focus on illegal products and counterfeits: We maintained focus on illegal products and counterfeits in 2009. A total of 52 samples were analysed and screened for the content of potency-enhancing or weight-reducing substances.

  • Work with method related activities: Among the methods we have worked with in 2009 are the development of flow cytometry based potency assay for freeze-dried BCG vaccine and detection of extraneous agents in veterinary virus vaccines by means of real-time PCR. We have also worked with cell therapy products.

  • Pilot projects on risk management: During 2007-2008, we completed three pilot projects on the topic of risk management. In 2008, the Laboratory worked with the implementation of a general risk management model based on experience from these three pilot projects. This work continues into 2010.

Danish Medicines Agency, 14 June 2010