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
- 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
- Continuation of the initiative for biomarker development
and the validation of respective processes.
- Intensified cooperation for the regulation of veterinary
Further Information can be found here:
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.
On behalf of the European Compliance Academy (ECA)