EMEA Releases Draft Advanced Therapy Medicinal Product Procedures

The European Medicines Agency (EMEA) recently issued for public comment draft procedures for evaluating advanced therapy medicinal products (ATMPs). The agency’s Committee for Medicinal Products for Human Use (CHMP) and its Committee for Advanced Therapies (CAT) adopted the procedures in late March 2009. CAT was established in 2007 to assess the quality, safety, and efficacy of ATMPs, which EMEA defines as “medicinal products for human use, and are based on gene therapy, somatic cell therapy, or tissue engineering,” according to the agency’s advanced therapies website.

The draft procedures on ATMP evaluation specify the roles and responsibilities of two assessment teams involved in ATMP evaluations and outline a 246-day procedure between CAT and the applicant to conduct the full evaluation. For example, the applicant must provide responses to CAT questions on the 121st day of the evaluation and a final draft summary of the product on the 171st day. Upon approval-no later than day 215, according to the draft document-it is the applicant’s responsibility to submit information to EMEA.

Comments on the draft evaluation procedures are due July 6, 2009, and can be sent to Monika.Katonova@emea.europea.eu.

CAT also recently issued procedural advice on the provision of scientific recommendation about the classification of ATMPs. Scientific recommendation is optional for applications, but the 60-day procedure is meant to determine whether a product based on genes, cells, or tissues meets the official definition of an ATMP so that related questions may be addressed before an applicant submits a marketing authorization application or other information to EMEA. Comments on the procedural advice document are due on June 8, 2009, to Monika.Katonova@emea.europea.eu.