Spring Intro 2023

03/03/2023

Types of Marketing Authorisation Approvals – Conditional MAA

In the case of certain categories of medicinal products, in order to meet unmet medical needs of patients and in the interests of public health it may be necessary to grant marketing authorisations on the basis of less complete data. All of the following must be met for a CMA to be granted: ● Risk-benefit balance is positive (the Applicant must be sufficient data to allow this determination) ● Medicine will fulfill an unmet medical need ● Likely the applicant can provide comprehensive data post-authorisation ● Benefit of immediate availability to patients is greater than the inherent risk that additional data is required Once the post approval commitments are fulfilled, the license will become a ‘normal’ MA. Required to complete or initiate certain studies with a view to confirming that the risk-benefit balance is positive and resolving any questions relating to the quality, safety and efficacy of the product. Enhanced pharmacovigilance. (e.g. 6-monthly submission of PSURs) MA only valid for 1-year  Annual renewal required

EMA link: Conditional marketing authorisation

The Organisation for Professionals in Regulatory Affairs

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Types of Marketing Authorisation Approvals – Exceptional Circumstances

Products for which the applicant can demonstrate that comprehensive data cannot be provided might be eligible for marketing authorisation under ‘exceptional circumstances’ The fulfilment of any specific procedures/obligations imposed as part of the marketing authorisation will not normally lead to the completion of the full dossier (in contrast to Conditional Marketing Authorisation). Justification for submission under Exceptional Circumstances: ● Inability to provide comprehensive efficacy and safety data due to rarity of the indication ● Inability to provide comprehensive efficacy and safety data due to present state of scientific knowledge (eg certain diagnostic tools have not yet been developed in order to specifically study defined patient populations). ● Inability to collect such information because it would be contrary to medical ethics.

EMA link: Guidance on granting MA under Exceptional circumstances

The Organisation for Professionals in Regulatory Affairs

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