Conditional marketing authorisation

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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.

Conditional marketing authorisations may be granted if the CHMP finds that all the following requirements are met:

  • 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.

Conditions for marketing-authorisation holders

Conditional marketing authorisations are valid for one year and will be reviewed annually.

The holder will be required to complete specific obligations (ongoing or new studies, or collection of pharmacovigilance data) 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).

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, applicants should notify the Agency of their intention to submit an application for a conditional marketing 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 may also present a 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.

Comparison with marketing authorisation under exceptional circumstances

Marketing authorisation under exceptional circumstances may also be a possible support mechanism in case of less comprehensive data. However, a marketing authorisation granted in exceptional circumstances can normally not be replaced with a standard marketing authorisation.

Conditional marketing authorisationMarketing authorisation under exceptional circumstances
Authorisation while the collection of comprehensive data is ongoing in order to address unmet medical needs. Comprehensive data are still being generated post authorisation in agreed timelines.Authorisation when comprehensive data on efficacy and safety cannot be obtained, but it is still appropriate to grant the authorisation due to exceptional circumstances.

Medicinal products without comprehensive data belonging to at least one of the following categories:

  • seriously debilitating or life-threatening diseases;
  • emergency situations;
  • orphan medicines;

and fulfilling all of the following criteria:

  • positive risk-benefit balance;
  • the applicant is likely to be able to provide comprehensive data;
  • addressing an unmet medical need.

Benefits of immediate availability outweigh the risks that additional data are still required.

Medicines without comprehensive data on efficacy and safety under normal conditions of use, respectively because:

  • indications encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence;
  • in the present state of scientific knowledge, comprehensive information cannot be provided, or it would be contrary to generally accepted principles of medical ethics to collect such information.
Authorisation valid for one year, can be renewed annuallyAuthorisation valid as normal, but EMA annually reassesses how well the specific obligations have been met and how the data which generated as a result of those obligations impacts the medicine's benefit-risk-balance
Once applicants provide comprehensive data, it can become a 'standard' marketing authorisationWill normally not lead to the completion of a full dossier to become a 'standard' marketing authorisation

 

Please refer to pre-submission guidance question 42: 'Is my medicinal product eligible for approval under exceptional circumstances?’ for details.

Further guidance

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