The MHRA offers a national Conditional Marketing Authorisation (CMA) scheme for new medicinal products.
Under what circumstances is a Conditional Marketing Authorisation (CMA) available for a medicinal product?
In cases where a medicinal product fulfils an unmet medical need, the MHRA may grant a CMA where comprehensive clinical data which are normally required, are not yet complete, but it is judged that such data will become available soon.
Which products are eligible for a CMA?
The scheme is aimed at products that fulfil an unmet medical need:
- for the treatment, prevention or diagnosis of seriously debilitating or life-threatening diseases; or
- for a product to be used in emergency situations, in response to public health threats.
What are the criteria for a CMA that an applicant can demonstrate?
The following are criteria for a CMA that an applicant can demonstrate:
- The balance of benefit and risk of the medicine is positive. The Marketing Authorisation Application (MAA) must contain adequate evidence of safety and efficacy to enable the MHRA to conclude that the risk-benefit balance of the medicinal product is positive.
- It is likely that the applicant will be able to provide comprehensive clinical data following authorisation.
- The medicine fulfils an unmet medical need. “Unmet medical need” means medical need in relation to a condition for which there is currently no satisfactory method of diagnosis, prevention or treatment authorised in the UK, or, if one exists, the medicinal product will offer a major therapeutic advantage to those affected.
- 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.
Is there a specific route of application for a CMA?
There is no specific application route for a CMA; applicants should submit their MAA dossier as for a full Marketing Authorisation at: https://www.gov.uk/government/collections/licencing-how-to-apply
- Applicants wishing to submit an application for a CMA to the MHRA should state their justification for a CMA and indicate clearly what clinical studies are underway and when comprehensive clinical data will become available.
- Eligibility for a CMA will be determined by the MHRA at the time of MAA assessment.
- At the completion of the assessment, the MHRA will determine whether to approve the application and grant a CMA or whether the risk benefit ratio is negative and reject the application.
- The designation of a product as being eligible for a CMA by the EMA or another jurisdiction may be taken into account by the MHRA, but the final decision on eligibility of the product for the UK scheme will rest with the MHRA.
Are CMAs granted for GB or the UK?
Until implementation of the Windsor Framework on 1 January 2025 CMAs can only be granted by MHRA for Great Britain (England, Wales and Scotland).
- In Northern Ireland, until that date, a CMA is only available through the EMA’s Centrally Authorised Procedure as laid down in Regulation (EC) No 726/2004.
- From 1 January 2025, the MHRA will grant UK-wide CMAs for products in line with the conditions set out in Regulation 50I of the Human Medicines Regulations 2012 (as amended) and explained in this guidance.
- These products will be authorised as Windsor Framework Category 1 products. Please refer to further guidance on these categories: UK-wide licensing for human medicines – GOV.UK (www.gov.uk)
What will be the validity of a CMA once granted?
CMAs will be valid for one year and will be renewable annually, upon application by the marketing authorisation holder (MAH).
Can a CMA be converted into a standard (full) marketing authorisation?
Yes, the marketing authorisation can be converted into a standard (full) marketing authorisation (no longer subject to specific obligations) once the MAH fulfils the obligations imposed and the complete data confirm that the medicine’s benefits continue to outweigh its risks.
What are the steps that a Marketing Authorisation Holder must fulfil once a CMA has been granted?
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.
Source: MHRA