Conditional Marketing Authorization Has Positive Impact in Europe

The European Medicines Agency (EMA) has published an analysis of the past 10 years of conditional marketing authorizations the agency has granted. Data collected from 2006–2016 show a total of 30 drugs received conditional marketing authorization during that time. These drugs included treatments for HIV, breast cancer, and epilepsy in infants, as well as 14 treatments for orphan diseases. Oncology was the top therapeutic area with 17 drugs receiving conditional marketing authorization. EMA states that in the past 10 years, no drug that received conditional marketing authorization had its authorization revoked or suspended.

The report shows that “more than 90% of completed specific obligations did not result in major changes of scope and about 70% of specific obligations did not require an extension to the originally specified timelines.” An average of four years was required to generate the additional data needed to convert the conditional authorizations into a full marketing authorizations. Data used to grant conditional marketing authorizations is characterized in the report, which the agency thinks may be of interest to companies developing drug products.  

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.