The CMC Strategy Forum Latin America 2019 took place in Brazil, on March 12th-13th. The event focused on regulatory update and featured an opening session including presentations from regional regulators, as well as the FDA.
FIFARMA was represented by Dr. Thomas Schreitmueller, Global Lead for Regulatory Policy at Roche and FIFARMA’s Regulatory & Biologics Working Group Co-Chair.
Dr. Schreitmueller participated in the session around life cycle management (LCM) for biotherapeutic product pitchings: Why We Need Effective LCM Regulatory Systems Now and Even More in the Future, which delivered regulatory key considerations on post-approval changes for pharmaceutical products facilitating global regulatory convergence.
Dr. Schreitmueller affirmed that: “Innovative drug development approaches require innovative and strong regulatory systems and procedures. National regulatory agencies (NRAs) are encouraged to take into consideration and implement available internationally harmonized guidelines on that subject, for example from the World Health Organization (WHO) and the International Council of Harmonization (ICH) and thus ensuring global alignment and regulatory convergence”.
“The WHO post approval change guidance for biotherapeutic products (BTPs) has all features that will significantly facilitate the work related to product life-cycle both at industry and NRAs and should be implemented by regulatory agencies across LATAM”.
He further outlined “FIFARMA is fully aligned with the Pan American Network for Drug Regulatory Harmonization (PANDRH) and the recommendations coming from their IX Conference that we need to push a change in the regulatory paradigm, building regulatory systems solid, efficient and transparent based on concepts such as reliance, worksharing and international collaboration which also should be considered in the context of efficient regulatory LCM approaches”.
Dr Schreitmueller finished his talk by citing Dr Tedros Adhanom Ghebreyesus, WHO Director-General “We need innovation and disruption – not just for developing new products, but for developing new ways of delivering those products and new ways of working together to deliver results.”
The CMC Strategy Forum Latin America 2019 offered a successful space for panel discussions designed to stimulate exchange of ideas and information around regulations and regulatory processes related to biotherapeutic products.
Authors: Thomas Schreitmueller – Roche Global Lead for Regulatory Policy
Co-Chair of FIFARMA’s Regulatory & Biologics Working Group
María Alejandra De Guzman – FIFARMA Communications Manager