Conditional MA: conditional marketing authorisation
A conditional marketing authorisation is a one-year, renewable EU authorisation granted on less complete data for medicines that meet an unmet need.
Conditional marketing authorisations are provided for in Article 14-a of Regulation (EC) No 726/2004 and detailed in Commission Regulation (EC) No 507/2006. They are available only in the centralised procedure, for medicines intended to treat, prevent or diagnose seriously debilitating or life-threatening diseases, for use in emergency situations in response to a public health threat, and for orphan medicines. The CHMP can recommend one where the benefit-risk balance is positive, the applicant is likely to be able to provide the comprehensive data later, unmet medical needs will be fulfilled, and the benefit to public health of immediate availability outweighs the risk of authorising on less complete data.
The authorisation carries specific obligations, listed in Annex II of the Commission decision, to complete ongoing studies or conduct new ones within set deadlines. It is valid for one year and renewed annually, with the holder submitting an interim report on the fulfilment of the obligations. Once the comprehensive data have been provided and assessed, the CHMP recommends conversion to a standard marketing authorisation, which is then valid for five years and renewable in the usual way. The product information and the EPAR state that the authorisation is conditional.
Applicants can ask for a conditional authorisation in the application or the CHMP can propose one during assessment when the data are not yet complete. Accelerated assessment and PRIME support are often combined with it for the same products. Under Article 4(2) of Commission Regulation (EC) No 507/2006, a conditional authorisation for a medicine intended for use in an emergency situation can be granted even where non-clinical or pharmaceutical data are still incomplete, as happened with several COVID-19 vaccines and treatments.
What goes wrong: obligations due dates that are missed because the confirmatory trial recruits slowly, which leads to a formal non-compliance finding and can affect renewal; a renewal application filed late, so the authorisation expires; study designs that change after grant without agreement with the CHMP; and commercial messaging that forgets the conditional status, which must be clear to prescribers. Holders also sometimes plan on conversion at the first renewal, whereas conversion happens only when the full data set has been assessed.
Timing
A conditional authorisation is valid for one year from the Commission decision. The renewal application, with the interim report on specific obligations, is due six months before expiry, and the CHMP gives its opinion within 90 days of receipt. Specific obligations have individual deadlines in the authorisation. Once the comprehensive data have been submitted and assessed, the authorisation is converted into a standard five-year authorisation; until then it remains conditional and annual renewals continue.
Used in
Teams holding conditional authorisations plan annual renewals and specific obligation deadlines together in the lifecycle planning workflow.
Related terms
- Exceptional circumstances: marketing authorisation without comprehensive dataAn authorisation under exceptional circumstances is granted when full efficacy and safety data cannot be obtained, with obligations reviewed yearly.
- Accelerated assessment: shortened centralised assessment for major public health interestAccelerated assessment shortens the CHMP's review of a centralised application from 210 to 150 days for a medicine of major public health interest.
- Centralised procedure: single EU marketing authorisation via EMAThe centralised procedure grants one marketing authorisation valid across the EU and EEA after a single EMA assessment and a Commission decision.
- Renewal: five-year re-evaluation of a marketing authorisationA renewal is the re-evaluation of a marketing authorisation's benefit-risk balance after its first five years, after which it is normally unlimited.
- CHMP: Committee for Medicinal Products for Human UseThe CHMP is the EMA committee that assesses centralised applications and referrals for human medicines and adopts the opinions behind Commission decisions.
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