To the challenges of a global supply chain, the FDA reacts with a package of measures. After having already opened three offices in China and two in India, shortly the Agency will establish offices in Costa Rica (San Jose) as well as in Chile (Santiago). In Europe, offices will be set up in Belgium (Brussels), England (London) and Italy (Parma). This was announced by Thomas Arista from the FDA Office of Regulatory Affairs on the occasion of the 3rd European GMP Conference in Heidelberg at the end of June.
Thomas Arista explained that the FDA has to supervise more than 100,000 firms manufacturing products (e. g. food, medicinal products, medical devices) outside the US. The supervision of these products and manufacturers cannot be accomplished by the FDA alone. Therefore, it is the Agency's aim to strengthen the international co-operation. It is in this light, too, that the FDA sees the establishment of offices abroad. Thomas Arista recommended to the European industry to contact the local representatives in case of arising compliance questions in the quickest possible way, preferably by telephone. Their presence on site enables a direct and thus much quicker exchange of information than before.
The European GMP Conference was organised by the University of Heidelberg, the European Compliance Academy and the European QP Association. ECA members can download Thomas Arista's presentation in the ECA Members Area. There you will also find an update on the developments in the field of the European GMP regulations by Dr Bernd Renger (Vetter Pharma, Chairman European QP Association).
On behalf of the European Compliance Academy (ECA)