The Latin America Federation of the Pharmaceutical Industry (FIFARMA) is advocating the need for the agencies in the region to extend the progress they have been making in regulating the approval process for biologics and cooperate on filling the regulatory gaps for their life-cycle management.
As more biologics and biosimilars are approved in the region, what is “urgently” needed, the federation of associations is stressing, is a common agreement on a viable risk-based approach for regulating the post-approval changes of these products.
At the opening regulatory session of the CMC Strategy forum, focused on “regulatory convergence, predictability, transparency and priority reviews in Latin America,” (IPQ December 27, 2015) the head of FIFARMA’s Regulatory and Biologics Working Group Thomas Schreitmueller took the opportunity to direct attention to the consequences of the current lack of a harmonized coherent approach to biologic life-cycle management and outlined the pathway that FIFARMA is advocating for achieving it.
Schreitmueller is the Biologics Regulatory Policy Head for Roche. FIFARMA includes the Federation of Central American Pharmaceutical Laboratories (FEDEFARMA) and the Association of Pharmaceutical Laboratories Research and Development (AFIDRO) among its members.
Representing FIFARMA, Schreitmueller explored why a commonly adopted risk-based approach for post-approval change regulation for biologics is important. His remarks further underscore the need for the ICH Q12 effort. The dialogue that took place at the forum shed additional light, in particular, on the challenges that will be on the table in implementing the ICH guideline globally [Editor’s Note: See IPQ December 1, December 17, and December 18 for more on the global post-approval change landscape and the potential impact of the Q12 effort.]