The European Medicines Agency (EMA) has published a report with data collected between 2006 and June 2016 on Conditional marketing authorisation (CMA). CMA can speed up access to medicines for patients with unmet medical needs. Since 2006, a total of 30 medicines have received a conditional marketing. Medicines that were granted a CMA target seriously debilitating or life-threatening conditions, among which were 14 were orphan medicines. These are some of the findings of a report by the European Medicines Agency (EMA) to mark ten years of experience with CMA.
EMA’s report is an analysis of the positive impact this tool has had in providing early access to new medicines for patients who previously had no or only unsatisfactory treatment options. It focuses on how CMAs are granted or refused and later converted into standard marketing authorisations. It also analyses the type, amount and timing of data provided to support these decisions. Over a period of 10 years, no medicine with a CMA had to be revoked or suspended.
During the time the CMA is granted, the company is obliged to carry out further studies to obtain complete data. EMA’s Committee for Medicinal Products for Human Use (CHMP) assesses the data and then recommends either the renewal or not of the CMA or its conversion into a standard marketing authorisation. According to EMA’s analysis, 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. The report shows that it took an average of four years to generate the additional data needed and to convert a CMA into a full marketing authorisation. This means that patients with life-threatening or seriously debilitating conditions can access promising medicines earlier.
According to the report, the data on which CMAs have been granted and the additional data generated through specific obligations could also be of interest for those developing medicinal products, as well as patients, pricing and reimbursement bodies and other stakeholders.
The report also identifies a number of possible areas for improvement. These include:
- prospective planning of CMAs and early dialogue with EMA to support the generation of high-quality data, timely discussion of additional post-authorisation studies and their feasibility, and better data generation for completion of specific obligations;
- engaging other stakeholders involved in bringing a medicine to patients, in particular Health Technology Assessment bodies, to facilitate the generation of all data needed for decision-making through one development programme.