Spring Intro 2023

03/03/2023

EU Accelerated Assessment

Qualifying Criteria

• Medicinal products expected to be of major public health interest, justified on a case by case basis. - Unmet medical need - Extent to which the product will add value/address unmet medical need • Outline of data available for basis of claim of being a major public health interest

Note: ensure to vet/discuss associated requirements with key stakeholders (such as need for PL Reader Usability Testing at time of MAA submission, Orphan Maintenance report at time of submission).

Key features

• Time limit for assessment reduced from 210 to 150 days (TT varies for ATMPs) - But note this can revert to standard 210 review timelines if complex issues arise during review

Application information

• A request for accelerated assessment should be made at least 2-3 months before submitting the MAA (follows TT and must be approved) • Before submitting the request, applicants should seek guidance from the EMA and this would be the focus of a pre submission meeting (6-7 months before submission). Include draft justification in Pre-submission Interaction.

• Under the PRIME scheme applicants receive confirmation during the clinical development phase that their medicine might potentially be eligible for accelerated assessment.

EMA link: Accelerated Assessment

The Organisation for Professionals in Regulatory Affairs

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Summary and Conclusions

• The centralised procedure allows applicants to obtain a single marketing authorisation which is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway

• The EMA is a scientific body with expertise required to assess the benefits and risks of medicines. The EMA makes recommendations (opinions) to EU Commission Decision who then make a final legally binding decision

• For some medicines, using the centralised procedure is mandatory (e.g. orphans, and new active substances for AIDS, cancer)

• While there may be strategic reasons for choosing one route to authorisation over another (MRP/DCP/National/Centralised), the data requirements and standards governing the authorisation of medicines are the same regardless of the review process

• Significant activity, several years in advance of the planned MAA is needed to optimise and facilitate the use of centralised procedure e.g. orphan applications, multiple rounds of scientific advice and presubmission meetings

• The scientific assessment is lead by a Rapporteur and Co-rapporteur on behalf of the CHMP. It takes 210 days plus clock stops for the committee to make a recommendation to the EU Commission, who then issue a Decision in 67 days. • Regulatory approval in the EU is just the first step in the lifecycle of a medicine. Pricing and access discussions (national level) followed by lifecycle opportunities eg. new indications, formulations.

EMA link: interactive timeline “from lab to patient”

The Organisation for Professionals in Regulatory Affairs

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