Regulatory Roundup: EMA Issues Concept Paper for Public Consultation on Development of Toxicological Guidance for use in Risk Identification

EMA’s Committee for Medicinal Products for Human Use has issued a concept paper for public consultation on the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities. The paper is based on the current “lack of clarity in the existing GMP guide with respect to when a medicinal product should be manufactured in dedicated facilities.” The paper includes a proposal to revise certain sections of the GMP guide (3.6, 5.18, and 5.19), including the incorporation of quality risk management principles as described in the ICH Q9 guideline. The consultation period will close in January 2012 and a revised draft is expected in May 2012. Following that, a draft and final guidance will be issued by the first half of 2013, with a 6-month implementation deadline for industry.