Pharmaceuticals: impediments to inspect manufacturing practices

Fecha publicación: 2 March, 2015
Categorías: Logistics&Customs
Autor: Logistic - Customs

Negotiations regarding pharmaceutical inspections on manufacturing practices are being an impediment to close the TTIP agreement. That is what Mark Abdoo, a senior US Food & Drug Administration (FDA) official, has stated, noticing that the US doesn’t know whether to rely or not on the European’s own inspection process, aiming to finally treat the EU as a single entity.

Abdoo plans five more audits done by EU drug regulators this year. These audits analyses the EU rules for drug GMP –Good Manufacturing Practices- and how strict these inspections are for member states. FDA’s official is aware that due to this year’s calendar constrictions for observing EU audits, cover all 28 member states in a short term will be difficult.

FDA is also discussing medical devices with the EU in TTIP, and the possibility of relying on each side’s audits of medical device manufacturers. The aim is to conduct a single audit of a medical device manufacturer responding to all countries’ requirements. Nowadays, the medical device industry, even though common elements exist in the process, has to handle separate audits in order to sell their products in both sides of the Atlantic.


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Logistic - Customs

Logistic – Customs



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