Traceability Requirements in EU’s ATMP Regulation Need Tweaking: Pfizer

Language on traceability requirements in the EU’s 2007 regulation on innovative “advanced therapies” is overly broad and should be clarified in forthcoming guidance, pharma giant Pfizer says. In comments on the regulation, which covers drugs based on gene therapy, somatic-cell therapy and tissue engineering, Pfizer expressed support for the push to have each advanced therapy medicinal product linked to the recipient patient and vice versa.
International Pharmaceutical Regulatory Monitor