
Conditional Marketing Authorization Has Positive Impact in Europe
A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.
The European Medicines Agency (EMA) has
The
Conditional marketing authorization allows regulators in the European Union to support the development of and early access to drugs that treat unmet needs. Drugs may receive conditional marketing authorization, which is valid for one year, if it is determined that the health benefit outweighs the risk of an authorization with less comprehensive data. Companies must conduct further studies to obtain complete data, and EMA’s Committee for Medicinal Products for Human Use (CHMP) assesses post-authorization data annually to assess the benefit/risk balance. Based on its assessment, CHMP will either recommend to renew or not renew the conditional authorization or recommend standard marketing authorization.
Source:
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.