The need for a more structured, interactive process to drive convergence and resource sharing among the regulatory agencies of Central and South America – potentially drawing on elements of the European model – was a dominant theme among the industry and regulator participants in the second annual CMC Strategy Forum Latin America held again in late August 2015 in Brazil’s capitol city Brasilia.
The two-day forum, sponsored by CASSS with the support of the key regulatory agencies in the region, brought together industry and regulator CMC experts to review: ● the significant progress that has been made in recent years in strengthening the biopharmaceutical regulatory capacities in the region ● where the shortfalls remain, and ● how the region can move into closer alignment with the US, Europe and Japan, and keep pace with their evolving processes.
In her summary of the presentations and discussions presented at the forum’s conclusion, industry consultant Nadine Ritter (Global Biotech Experts) highlighted the consistency among the participants in wanting to strengthen the foundation for increased regulatory convergence and resource sharing – a desire heightened by the challenges that biotechnology presents and the limited resources available at the individual agency level to address them. [Ritter’s in-depth summary is provided in full below.]
Pointing to the increased involvement of countries in the region with international organizations like the World Health Organization (WHO), the Pan American Network for Drug Regulatory Authorities (PANDRA) and the Pan American Health Organization (PAHO), Ritter noted the desire echoed across the agencies represented to have more permanent interactions at that international level.