Under this procedure, the CPMP reviewed all biotechnology and other high-technology pharmaceutical products for approval across the EU. Because the CPMP opinions were not binding, Member States issued different decisions on drug approvals, which prevented pharmaceutical companies from obtaining EU-wide approval for their products. Although the new EU drug approval process changes the method for obtaining a marketing authorization, it does not affect drug pricing and reimbursement policies, which remain the responsibility of each Member State. CPMP opinions under the decentralized procedure, once accepted by the Commission, are binding on all the Member States. The decentralized approval procedure is expected to take between 300 and 686 days depending on whether other Member States object to the marketing authorization granted by the first Member State, objections lead to a formal arbitration by the CPMP, the applicant appeals an unfavorable opinion, the Member States raise important new scientific or technical questions, or the Standing Committee cannot reach consensus on a Commission draft decision and refers the matter to the Council of Ministers. Nevertheless, industry officials contend that future prospects for using the centralized procedure are dependent on the EMEA’s success in expediting the drug approval process. EMEA Tasks, Structure, Staffing, and Financing

The EMEA was created by the Commission in 1993 to administer the new centralized approval procedure, which is mandatory for biotechnology and optional for other high-technology and innovative pharmaceutical products. The EMEA is funded by the Commission and industry application fees and has a small permanent staff and two scientific committees that draw upon EU-wide scientific expertise. Under the centralized procedure, the EMEA is responsible for coordinating the evaluation of the safety, efficacy, and quality of human pharmaceutical products that will be marketed throughout the EU. European Medicines Evaluation Agency (EMEA)

Central agency within the EU that supports the CPMP in its scientific evaluations of pharmaceutical products. European Union (EU)

Formerly known as the European Community, the EU was established by treaty to create a single market.
Why GAO Did This Study

Pursuant to a congressional request, GAO reviewed: (1) the new European Union (EU) procedures for approving new drug applications (NDA); and (2) why the European Medicines Evaluation Agency (EMEA) was established, how it operates, and how it is financed.

What GAO Found

GAO found that: (1) because member states did not always accept EU or other members' drug approvals, the EU Commission of European Communities makes decisions on drug approvals and dispute resolutions that are binding on all members; (2) EU has also established new approval procedures for biotechnology, other high-technology, and innovative products; (3) regulating drug prices and reimbursement policies remains the responsibility of member states; (4) the centralized approval procedure for biotechnology and some innovative products is expected to take between 298 and 448 days; (5) the decentralized procedure allows manufacturers to seek approval from member states and appeal denied approvals; (6) the decentralized procedure is expected to take between 300 and 686 days; (7) industry officials are concerned about drug evaluators' qualifications and whether EU-wide interests will be upheld over national interests; (8) EMEA is responsible for the timeliness and coordination of new drug approvals, administrative duties, ensuring that drugs meet the highest standards of safety, efficacy, and quality, and maintaining information on the drugs and their adverse reactions; (9) the Commission and industry application fees fund EMEA, which has a small permanent staff and 2 scientific evaluation committees that draw on EU-wide scientific expertise; and (10) EMEA also provides advice to companies on their trial procedures and other matters.