QUES: Is there a specific section or chapter or any detailed considerations described for cell and gene therapies and how to deal with them in contrast to conventional drugs under the new Regulation ?
ANS: Short answer: No. Long answer: The CTR is a high level document, focused on subject safety and accuracy of the data generated. Also the simplification of the submission process. It discusses a risk-based (patient risk) approach to the submission documentation: By defining low intervention trials, EU-CTR enables a risk-based approach that EU-CTD could not sustain. Consequently, sponsors of low intervention studies may enjoy simpler submission dossiers (e.g., Summary of Product Characteristics [SmPC] used rather than IMP Dossier [IMPD]). They also may experience less stringent rules for monitoring, the content of the Trial Master File (TMF) and investigational product (IP) release.
The sponsor's claim of low-intervention or not is evaluated upon submission to the EU portal by qualified individuals in the assessing Member State - see CTR Articles 5.2, 6 and 25.
The cell and gene therapies trials would likely fall into a higher risk intervention trial, requiring more detailed submission dossiers, and tighter assessment and monitoring, etc., rules and release to the market evaluations.
-- jel@jelincoln.com
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