I was able to attend the session on Evaluating Medicines in the European Union at the AAPS 2010 annual meeting in New Orleans. Hilde Boone, EMA employee and in residence liaison with the US FDA, described the procedures, timing and parties involved during the application and review of a new drug (medicine) for marketing authorization (MA) in Europe. She also detailed the organizational structure of EMA and its relationship with member states, the EU, US and Japan. Throughout the presentation she emphasized the differences and similarities with the US FDA.
The EMA, headquartered in London with about 700 employees, operates under the EU. Funding comes from company fees when they submit applications (75%) and the 27 member states (25%). Pharmaceutical companies have two paths to bringing drugs to market—centralized, through the EU and driven by the EMA or decentralized, working in cooperation with a few member states (countries more active in the MA process or those where sales of drugs will be concentrated).
The EMA acts as a single coordinating body for drug safety and quality. Unlike the FDA it does not have different centers (CDER, CBER…) to address different drug categories. The EMA does not perform GxP inspections. Also unlike FDA, they do not investigate drugs. Inspections of facilities in the EU are carried out by regulators in each member state, which are initiated independently and from requests by the EMA.
Regarding MAs, the maximum period for making a decision is 277 days, including several assessment and evaluation periods. The EMA is supported by independent experts (4,500) throughout the EU, which are called upon to render assessments, advice and decisions. The EMA encourages companies to seek pre-submission advice, which is reported to lead to a higher percentage of granting authorizations to market a new drug, said Ms. Boone. A similar emphasis to use FDA resources early in the development process via the agency’s Pre-Investigational New Drug Application (Pre-IND) Consultation Program.
Increased public reporting of application outcomes is becoming more prevalent. Both agencies want to expand the public’s knowledge of medicines, medical devices, and cosmetics. The EMA publishes the results of all applications including those that fail the process or are withdrawn. As recently as Nov. 22, 2010, the FDA proposed recommendations to exposing deficiencies designed to encourage companies to be more thorough in the submission process. http://www.businessweek.com/news/2010-05-19/rejected-drugs-may-be-disclosed-by-fda-for-first-time-update3-.html
Cooperation between the two agencies has grown to the point of monthly conference calls on priority topics, shared reports and advice. The intent is to make better use of resources and as Ms. Boone puts it—harmonized advice. Both the EU and US congress are giving their respective agencies new responsibilities. In 2011, Ms. Boone mentioned that EU legislation will pass on new tasks and responsibilities to the EMA concerning pharmacovigilance (detection, assessment, and prevention of adverse effects) and counterfeit medicines.
