The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU.
Eligible products target diseases of major public health interest — such as vaccines or treatments for HIV, malaria, tuberculosis and others — and may include new formulations of products already authorized in the EU, the agency said. Sponsors can submit full applications, as well as applications for fixed combinations, generics and similar biologics, or informed consent.
After a sponsor applies for eligibility, the EMA’s Committee for Medicinal Products for Human Use draws up a scientific opinion in cooperation with the World Health Organization. Applicants or their contacts must be established in the European Economic Area.
The CHMP’s scientific opinion process is more thorough than its procedure for offering scientific advice, where sponsors ask questions regarding pre- and postmarket product development. The committee’s report will assess the quality, safety and efficacy of the product, as well as examine the risk-benefit balance based on intended populations and markets.