Conditional Marketing Authorisation

The approval of medicines that address unmet medical needs of patients on the basis of less comprehensive data than normally required.

What is Conditional Marketing Authorisation (CMA)?

The approval of a medicine that addresses unmet medical needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the benefit of immediate availability outweighs the risks of less comprehensive clinical data than normally required. Further, comprehensive clinical data may need to be provided in the future.

Who grants CMA?

The European Medicines Agency (EMA), specifically the Committee for Medicinal Products for Human Use (CHMP) grants CMA (1).

CMA applies to countries served by the European Medicines Agency (EMA), a decentralized agency of the European Union (EU) whose goal is to promote and protect human and animal health. EMA is the European Union’s equivalent to the U.S. Food and Drug Administration (FDA). Countries served by EMA include the 28 EU member states, plus Iceland, Liechtenstein, and Norway.

What are the conditions for granting CMA?

CMA may be granted for drugs that can be used to treat, prevent or diagnose seriously debilitating or life-threatening diseases, including drugs for orphan diseases. In addition, CMA may be granted in case of emergency situations in response to public health threats. (2)

In addition, all of the following conditions need to be met:

  • A positive risk-benefit balance, esp. the benefit of immediate public availability has to outweigh the risk of having less comprehensive data.
  • The likelihood that the applicant can supply comprehensive data is high
  • The drug targets an unmet medical need

In the US Accelerated Approval severs a similar purpose.

What are the terms of CMA?

A CMA is valid for one year and can be renewed annually. During that time the holder of the CMA has to meet the agency’s “specific obligations”.

These specific obligations include:

  • Completing ongoing studies or conducting new studies to confirm the positive risk-benefit balance and resolve any remaining questions around quality, safety and efficacy of the product
  • Collecting pharmacovigilance data (in certain cases)

Is CMA meant to be permanent?

No, conditional authorization is not intended to remain conditional indefinitely. Once the missing data are provided CMA should be replaced with a standard marketing authorisation, which is not subject to specific obligations.

References

(1) www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation

(2) https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2006_507/reg_2006_507_en.pdf

Community Leader
Corporate Advisory Boards