Conditional marketing authorisation
The European Medicines Agency (EMA) supports the development of medicines that address unmet medical needs of patients. In the interest of public health, applicants may be granted a conditional marketing authorisation for such medicines where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required, based on the scope and criteria defined in legislation and guidelines.
Medicines for human use are eligible if they belong to at least one of these categories:
- aimed at treating, preventing or diagnosing seriously debilitating or life-threatening diseases;
- intended for use in emergency situations (also less comprehensive pharmaceutical and non-clinical data may be accepted for such products);
- designated as orphan medicines.
- the benefit-risk balance of the product is positive;
- it is likely that the applicant will be able to provide comprehensive data;
- unmet medical needs will be fulfilled;
- the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data.
EMA has published a 10-year report on its experience with conditional marketing authorisations, with data collected between July 2006 and June 2016:
- Conditional marketing authorisation - Report on ten years of experience at EMA
- Annex 1 - Detailed information on conditional marketing authorisations
- Annex 2 - Detailed information on unsuccessful conditional marketing authorisations
- 10-year report highlights
During this period, 30 medicines received a conditional marketing authorisation. None had to be revoked or suspended.
The report shows that conditional marketing authorisation can help speed up patient access to new medicines.
It also calls for further improvements, including wider use of early dialogue between EMA and applicants and engaging further stakeholder groups, such as health-technology-assessment bodies.
Conditions for marketing-authorisation holders
Conditional marketing authorisations are valid for one year and can be renewed annually.
The holder will be required to complete specific obligations (ongoing or new studies, and in some cases additional activities) with a view to providing comprehensive data confirming that the benefit-risk balance is positive.
Once comprehensive data on the product have been obtained, the marketing authorisation may be converted into a standard marketing authorisation (not subject to specific obligations). Initially, this is valid for 5 years, but can be renewed for unlimited validity.
Applicants for a conditional marketing authorisation are advised to engage in early dialogue with EMA through scientific advice or protocol assistance and discuss their development plan well in advance of the submission of a marketing-authorisation application. Other stakeholders (e.g. health-technology-assessment bodies) can be included.
Six to seven months before submission, when applicants notify the Agency of their intention to submit an application for a marketing authorisation they should indicate also their intention to request a conditional authorisation. Applicants are encouraged to discuss their plans in a pre-submission meeting.
The applicant should present the formal request for a conditional marketing authorisation at the time of the application for marketing authorisation. The CHMP will assess the request as part of the assessment of the marketing-authorisation application.
If a conditional marketing authorisation is granted, the specific obligations and deadlines for their completion will be specified in the marketing authorisation. EMA will also make these conditions publicly available as part of the European public assessment report.
Distinction from authorisation under exceptional circumstances
Unlike conditional marketing authorisation, where marketing approval is granted in the likelihood that the sponsor will provide such data within an agreed timeframe, authorisation under exceptional circumstances can be granted when comprehensive data cannot be obtained even after authorisation. This authorisation route normally does not lead to a standard marketing authorisation.
For more information and comparison between these authorisation routes, refer to question: 'Is my medicinal product eligible for approval under exceptional circumstances?' of the pre-submission guidance.
- Pre-authorisation guidance, question: 'Could my application qualify for a conditional marketing authorisation?'
- Regulation (EC) No 507/2006
- Guideline on the scientific application and the practical arrangements necessary to implement Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004