Ten Years of Conditional Marketing Authorizations

The European Medicines Agency ("EMA") published a report ("EMA report") concerning the data collected over 10 years—between July 2006 and June 2016—on the so-called "conditional marketing authorizations" ("CMAs").

CMAs allow pharmaceutical companies in the European Union to obtain the authorization to place a medicinal product on the market provided they subsequently fulfill certain conditions. CMAs were designed for the purpose of speeding up access to various categories of medicinal products that address unmet medical needs of patients, including orphan products. They are regulated by Regulation 507/2006 on the conditional marketing authorization for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and the Council ("CMA Regulation").

The CMA Regulation allows the authorization of medicinal products if the public health benefit of the immediate availability to patients of a concerned medicinal product is deemed to outweigh the risk of an authorization granted on the basis of less comprehensive data than normally required for the purpose of obtaining a standard marketing authorization. A CMA is valid for one year. As part of the CMAs, companies marketing medicinal products are obliged to carry out further post-authorization studies to obtain more comprehensive safety, quality, and efficacy data.

The EMA's Committee for Medicinal Products for Human Use ("CHMP") assesses the data generated by these specific post-authorization obligations and, at the end of its assessment, provides an opinion on the renewal or not of the CMA or its conversion into a standard marketing authorization.

The EMA report highlights that, since 2006, 30 medicinal products were granted a CMA. Fourteen of the medicinal products that were granted a CMA were orphan medicinal products. The report also indicates that approximately 70 percent of the CMA holders completed their specific post-authorization obligations within the timelines specified by the EMA.

The EMA report also shows that it takes an average of four years to generate the additional data needed to convert a CMA into a standard marketing authorization. Based on 10 years of experience with the CMA Regulation, the EMA report also identifies a number of possible areas for improvement, including the prospective planning of CMAs and early dialogue with EMA to support the generation of high-quality data and the timely discussion of additional post-authorization studies and their feasibility.