Switzerland, home of Roche and Novartis, gets pass from EU API rule

Switzerland, home to such Big Pharma players as Roche ($RHHBY) and Novartis ($NVS), has been given a pass from some of the reporting requirements of the European Union's new API rules meant to keep counterfeit drugs out.

It is the first country to be given a waiver from the falsified medicines directive, which in July 2013 requires active pharmaceutical ingredient manufacturers outside the EU to meet EU GMP standards, in-PharmaTechnologist reports. The APIs of foreign makers must be accompanied by "confirmation" from regulators in their country that their plants measure up to EU GMP levels and can be banned if they don't have a seal of approval. That is unless an entire country gets an exemption because the EU determines its API manufacturing and oversight controls are on par with the EU, like Switzerland just got. Other countries that have applied include Israel, home of giant generics maker Teva Pharmaceutical Industries ($TEVA), as well as Singapore, Australia and Brazil, in-PharmaTechnologist says.

The pass for Switzerland comes even as the European Fine Chemicals Group (EFCG) has called on the EU to institute "mandatory inspections of all global API manufacturers." It says the cost of sending inspectors into foreign plants could be shared with the U.S. and other countries through mutual recognition agreements, relying on inspections conducted by partners. It is an approach the U.S., Europe, Australia and others are already exploring in the face of the fact that the bulk of API manufacturing is now being done in low-cost countries like China and India that have burgeoning industries and flagging regulatory oversight.

There has been some concern, particularly in the U.K., that some countries and manufacturers might not get their acts together before the deadline, leading to a shortage of APIs. India has said it is reviewing how to meet the requirement. In-PharmaTechnologist points out that the EU said in a FAQ about the rule that foreign plants recently approved by an agency like the FDA might use that information for their confirmation documents and that "It is not necessary to conduct an inspection specifically for the purpose of issuing the 'written confirmation.'"

- read the in-PharmaTechnologist story
- here's the Q&A (pdf)