European Commission, EMEA and FDA decide to intensify cooperation

  
One of the topics at the Transatlantic Economic Councils (TEC) meeting on 13 May was a more intensive cooperation of the European Commission, the European Medicines Agency (EMEA) and the US Food & Drug Administration (FDA). During the discussion it was emphasised how important this cooperation is relative to the regulation of medicinal products. Furthermore, several projects already initiated during a common workshop in Brussels, Belgium, in 2007 have been agreed on:

• Within a pilot phase the FDA and the EMEA plan on jointly inspecting pharmaceutical companies in the US and in Europe. The plan also comprises common inspections of API manufacturers in third countries.
• Inspection schedules, and results, including important information on inspected manufacturing sites, will be regularly exchanged.
• Set up a collaboration to determine in what scope dedicated facilities for certain drugs are necessary (based on a risk to be determined).
• Continuation of the initiative for biomarker development and the validation of respective processes.
• Intensified cooperation for the regulation of veterinary drugs.

Further Information can be found here:
http://www.eurunion.org/eu/index.php?option=com_content&task=view&id=1753&Itemid=58

The TEC is a joint political-level body with members from the US Cabinet and the European Commission. It is lead by Günter Verheugen (Vice President European Commission) and Daniel Price (Assistant to the President for International Economic Affairs). Through an improved cooperation and coordination of activities, the council wants to take advantage of the involved authorities' resources more efficiently, to generate economic advantages and higher standards in regard to product safety and protection. This is the council's goal not only with respect to trade of medicinal products, but, for example, also to food products, cosmetics, electronics, finances and trade in general. The consequences of REACH are also discussed.

The pharmaceutical industry welcomes this development. The intensified cooperation among the authorities can be seen as a further step towards harmonisation of the requirements and regulations. It remains to be seen whether this cooperation also leads to a mutual recognition of inspections.

Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)