Module 1 2021

30/06/2021

ATMP Classification

 consult EMA to determine if a medicine they are developing is an ATMP. The procedure allows them to receive confirmation that a medicine, which is based on genes, cells or tissues, meets the scientific criteria for defining an ATMP.  The classification procedure is optional.  EMA established the procedure to address questions on borderline classification with other areas, such as medical devices, as early as possible.  EMA's Committee for Advanced Therapies (CAT) delivers scientific recommendations on ATMP classification after consultation with the European Commission within 60 days after receipt of the request.  Request form and background information including background information on scientific, legal, regulatory and medical aspects

The Organisation for Professionals in Regulatory Affairs

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Accelerated Assessment Strategic Choice

 Request before submission, (2 to 3 months)  Reduces Timelines from 210 to 150 days • 90+30+30 days; 1 month clock stop after day 90  Major Public health Interest ● Particularly from the point of view of therapeutic innovation;  Justification of Public Health Interest

● Unmet medical need, new methods of therapy, improves on existing methods;  If at day 120 or 150 CHMP or Applicant consider accelerated assessment no longer appropriate, assessment may continue under standard timelines  Applicant needs to be ready to submit responses in short period

The Organisation for Professionals in Regulatory Affairs

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