Conditional marketing authorisation
The European Medicines Agency (EMA) supports the development of medicines that address unmet medical needs. In the interest of public health, applicants may be granted a conditional marketing authorisation for such medicines on less comprehensive clinical data than normally required, where the benefit of immediate availability of the medicine outweighs the risk inherent in the fact that additional data are still required.
Medicines for human use are eligible if they are intended for treating, preventing or diagnosing seriously debilitating or life-threatening diseases. This includes orphan medicines.
Its use is also intended for a public health emergency (e.g. a pandemic). For these medicines, less comprehensive pharmaceutical and non-clinical data may also be accepted.
The legal basis is Article 14-a of Regulation (EC) No 726/2004. The provisions for granting a conditional marketing authorisation are further elaborated in Regulation (EC) No 507/2006.
EMA's CHMP may grant a conditional marketing authorisation for a medicine if it finds that all of the following criteria are met:
- the benefit-risk balance of the medicine is positive;
- it is likely that the applicant will be able to provide comprehensive data post-authorisation;
- the medicine fulfils an unmet medical need;
- the benefit of the medicine's immediate availability to patients is greater than the risk inherent in the fact that additional data are still required.
Conditional marketing authorisations are valid for one year and can be renewed annually.
Once a conditional marketing authorisation has been granted, the marketing authorisation holder must fulfil specific obligations within defined timelines.
These obligations could include completing ongoing or new studies or collecting additional data to confirm the medicine's benefit-risk balance remains positive.
EMA publishes the conditions of the marketing authorisation in the medicine's European public assessment report.
The marketing authorisation can be converted into a standard marketing authorisation (no longer subject to specific obligations) once the marketing authorisation holder fulfils the obligations imposed and the complete data confirm that the medicine's benefits continue to outweigh its risks. Initially, this is valid for 5 years. It can then be renewed for unlimited validity.
As for any medicine, if new data show that the medicine’s benefits no longer outweigh its risks, EMA can take regulatory action, such as suspending or revoking the marketing authorisation.
EMA can also take regulatory action if the company does not comply with the imposed obligations.
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Conditional marketing authorisation is a pragmatic tool for the fast-track approval of a medicine that fulfils an unmet medical need. Despite earlier approval, it guarantees that the medicine meets rigorous EU standards for safety, efficacy and quality and that comprehensive data is still generated post-approval.
It offers a robust post-authorisation regulatory framework based on legally binding obligations, safeguards and controls.
During the COVID-19 pandemic, the conditional marketing authorisation procedure is being used to expedite the approval of safe and effective COVID-19 treatments and vaccines in the EU.
This is in line with EU legislation which foresees that conditional marketing authorisation is used as the fast-track authorisation during public health emergencies to speed up approval and save lives.
It allows regulators to grant a marketing authorisation as soon as sufficient data becomes available to demonstrate that the medicine's benefits outweigh its risks, with robust safeguards and controls in place post-authorisation.
In a public health emergency, it can also be combined with a rolling review of data during the development of a promising medicine, to further expedite the evaluation.
Conditional marketing authorisation is the most appropriate tool to grant access to COVID-19 vaccines to all EU citizens at the same time and to underpin mass vaccination campaigns.
For information on authorised COVID-19 medicines and those currently undergoing evaluation, see Treatments and vaccines for COVID-19.
For more information on EMA’s expedited evaluation procedure for COVID-19 vaccines in the EU, see COVID-19 vaccines: Scientific evaluation and approval: Accelerated evaluation.
For guidance for developers of COVID-19 treatments and vaccines, see COVID-19 guidance: evaluation and marketing authorisation.
EMA advises applicants to discuss their development plans with the Agency via scientific advice or protocol assistance early in the development process. Involving health technology assessment bodies early is also encouraged, which is possible via EMA's parallel consultations procedure.
The applicant should indicate a request for conditional marketing authorisation in their notification of intention to submit a marketing authorisation application. They should submit this 6 to 7 month before submitting the application.
EMA also encourages applicants to further discuss their plans with EMA as part of a pre-submission meeting.
For products deemed suitable for a conditional marketing authorisation, EMA encourages applicants to also consider requesting accelerated assessment.
Applicants should include a formal request for a conditional marketing authorisation in their marketing authorisation application. The CHMP will assess this request together with the application.
For detailed guidance, see:
- Pre-authorisation guidance: Question 1.9 - 'Could my application qualify for a conditional marketing authorisation?'
- 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
- Obtaining an EU marketing authorisation, step-by-step
- Accelerated assessment
- Guidance for medicine developers and other stakeholders on COVID-19 (for COVID-19 treatments and vaccines)
EMA 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, EMA can grant authorisation under exceptional circumstances 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, see:
- Pre-authorisation guidance: Question 1.10 - 'Is my medicinal product eligible for approval under exceptional circumstances?'
The latest statistics on the conditional marketing authorisations granted by EMA are available in the Agency's annual reports.
EMA's 10-year report on the conditional marketing authorisation provides a detailed analysis and review of the Agency's experience with this type of authorisation in its first 10 years of application. It covers data collected between 2006 and 2016:
- Conditional marketing authorisation - Report on ten years of experience at EMA
- Annex 1 - Information on conditional marketing authorisations
- Annex 2 - Information on unsuccessful conditional marketing authorisations
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.