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.
Criteria for Conditional marketing authorisation
- 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.
Validity of Conditional marketing authorisation
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.
Approval process of the Conditional marketing authorisation
1. Applicants for a conditional marketing authorisation should involve in early dialogue with EMA through scientific advice or protocol assistance and discuss their development plan.
2. 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.
3. Also check your product is suitable for accelerated assessment. If so do process the accelerated assessment request.
4. 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.
5. 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.