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.
Application process
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.
For products deemed suitable for a conditional marketing authorisation, applicants are also encouraged to consider requesting accelerated assessment.
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
The Agency may also grant a marketing authorisation in absence of comprehensive data 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.