The Drug Information Association (DIA) recently sponsored “Latin America Regulatory Conference 2019” in Miami, US on February 21st – 22nd.
The symposium offered engaging panels led by health influencers discussing the advancement and implementation of regulatory convergence initiatives in Latin America.
FIFARMA was represented in this event by Dr. Thomas Schreitmueller, Global Lead for Regulatory Policy at Roche and FIFARMA’s Regulatory & Biologics Working Group Co-Chair. He participated in the session entitled Lifecycle Management – How to Cope with the Increasing Regulatory Demand on Post-Approval Changes for Faster Medicines Access. This session covered the most recent regulatory updates on post-approval changes for pharmaceutical products facilitating global regulatory convergence.
According to Thomas Schreitmueller: “The regulatory management of post-approval changes for pharmaceutical products currently is a highly complex, redundant and inefficient process on a global basis. National regulatory agencies (NRAs) are encouraged to take into consideration and implement available internationally harmonized guidelines on that subject e.g. from the World Health Organization (WHO) and the International Council of Harmonization (ICH) and thus ensuring global alignment and regulatory convergence. At the same time processes should be established that will allow a NRA to take into account the assessment work already done by another NRA with recognized expertise. These reliance processes will reduce redundancies significantly e.g. currently a product change incl. the same justification and data may be assessed by all NRAs in the world coming to the same conclusion. Having globally implemented harmonized regulatory guidance and having established reliance based, regulatory processes will ensure the availability of any medicine with the most up-to-date quality at the same time all over the world for the patients that need it. In that sense 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 foster a change in the regulatory paradigm, building regulatory systems solid, efficient and transparent based on concepts such as reliance, worksharing and international collaboration. Let’s start working on it, together, now!”.
The Latin America Regulatory Conference was attended by global regulators, industry, and academia to identify opportunities for regulatory harmonization to reduce lifecycle management complexity for patient’s benefit.
“At FIFARMA we strive to support events such as the Latin America Regulatory Conference, organized by DIA, which highlight and develop intelligence about key topics for the biopharmaceutical industry in our region, such as regulatory harmonization and pharmacovigilance”, said Juan Carlos Trujillo, International Policy and Operations Director at FIFARMA.