Marketing approval rule changes agreed

Reforms to the EU's pharmaceutical marketing approval rules have been agreed by the European Parliament with the aim of boosting competitiveness and innovation. They are supposed to build on the record of the European Medicines Evaluation Agency (EMEA) and include a new fast-track authorisation procedure, the possibility of conditional authorisation for products and harmonised periods of intellectual property protection.

There are also clearer rules and procedures for the generic pharmaceutical industry, allowing manufacturers, for instance, to start testing products in advance of the expiry of patents.