The formal creation of a forum of regulatory entities overseeing clinical trials, ongoing training of regulators, and the need for flexible regulatory frameworks that can efficiently respond to technological advances and unforeseen situations were three recommendations highlighted by the clinical trials panel at the XI Conference of the Pan American Network on Drug Regulatory Harmonization (XI CPANDRH), co-organized by PAHO and the Mexican government.
Four hundred and fifty people attended this conference in Mexico City from August 21-23, 2024, including delegates from national regulatory authorities (NRAs), pharmaceutical companies and associations, health authorities, PAHO staff and other stakeholders.
In the panel on clinical trials, Dr. Patricia Saidón (IMT/QR-PAHO) presented the tasks of NRAs regarding the oversight of clinical trials on drugs and medical devices seeking authorization, as established by the guidelines of Good Clinical Practice (GCP) of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Dr. Carla Saenz, PAHO’s Regional Bioethics Advisor (EIH/SK), focused on distinguishing this regulatory oversight from the ethical oversight of research with human participants conducted by research ethics committees following the CIOMS International Ethical Guidelines for Health-related Research Involving Humans.
In the session, which sought to ensure that both ethical and regulatory oversight of clinical trials are carried out in accordance with international standards, Dr. Agustina Bisio, from the National Administration of Drugs, Food and Medical Devices (ANMAT) of Argentina, presented the country’s experience overseeing the COVID-19 vaccines trial for which no other country or NRA was involved. Representing the Latin American Federation of the Pharmaceutical Industry (FIFARMA), Dr. Francisca Rodriguez explained the impact of clinical trials on the economy, and the importance of countries’ rigorous and efficient supervision for the conduct of clinical trials by the industry.
PAHO coordinates a regional agenda to strengthen clinical trials, as part of the implementation of the WHO clinical trials resolution (WHA 75.8), and is currently carrying out a series of virtual seminars on topics related to the conduct of clinical trials in a joint effort between EIH/SK (Bioethics) and IMT/QR to strengthen research capacities in the region.
Related links
Webinar video: What are the regulatory tasks in the oversight of clinical trials?
