Europe learns from US drug mistakes.

ABSTRACT

AIDS The European Medicines Evaluation Agency (EMEA) has a role in drug approval similar to the Food and Drug Administration (FDA). One of EMEA's biggest challenges is to resolve the differences in opinion over the use of surrogate markers to approve anti-HIV drugs. The EMEA's document, Points to Consider in the Assessment of Anti-HIV Medicinal Products, specifies its policies related to clinical trials and risk/benefit analyses. Because U.S. regulations are open to interpretation, experimental drugs are often approved. The European criterion has tighter controls on experimental drugs, although they allow rapid approval of drugs to immediately benefit very sick patients.^ieng