FIFARMA Participates in the AMEPRES 6th International Meeting on Health Regulation
The 6th International Meeting on Health Regulation, organized by the Mexican Association of Health Regulatory Professionals (AMEPRES) took place between November 9th and 12th, 2021 in a virtual way. This is an event of great importance for the health regulation sector of medical products or health supplies in Latin America, and was attended by health authorities, representatives of the pharmaceutical industry, international organizations, consultants and opinion leaders from the region.
Cammilla Gomes (Leader of Regulatory Policies at Roche) and Leonardo Semprun (Leader of Regulatory Policies at MSD) represented the Regulatory and Biological Working Group of FIFARMA in the session entitled: “Good Regulatory Practices and Reliance”, moderated by the QFB with Stephan Jarpa of the Inhouse Agency. This session also had the participation of Dr. Heriberto Garcia – Director of the Chilean Institute of Public Health (ISP), of Ileana Fleitas -representative of the Pan American Health Organization (PAHO), and Dr. Mario Alanis, from the Center for Innovation in Regulatory Science (CIRS).
The discussion was prompted by the recent publication (April 2021) of World Health Organization’s Guidelines for Good Regulatory Practices (GRP) and Good Reliance Practices (GReIP) . These WHO guidelines aim for countries to improve the monitoring and regulation of medicines and other medical products, as well as to promote greater collaboration among regulators at regional and international levels, in order to leverage resources more efficiently and ensure that safe, effective, and quality medical products reach people more quickly.
In its intervention, FIFARMA highlighted and reinforced the importance of Good Regulatory Practices (GRP) as principles and procedures that ensure consistent and effective regulation, as a fundamental element for the sustainability of the health system in the countries. The facilitators, and considerations for the practical implementation of GRPs, which allow or facilitate the strengthening of institutional capacity for regulatory management and social control in the regulatory process were also mentioned.
In addition, FIFARMA presented industry considerations regarding the implementation of regulatory compliance mechanisms, or the use of regulatory decisions from other jurisdictions, which is a global issue that has gained traction in conversations about how to improve the capacity of the regulatory system and how to increase its efficiency, and facilitate regulatory decision-making.
During the discussion, it was mentioned how National Regulatory Agencies (NRA) consider different reliance options in the context of their needs, and the characteristics of the national health and regulatory system. During the debate, panelists exchanged views on the use of reliance as a functional and practical way of regulating medical products and health supplies in a globalized world, for example with multiple supply chains, sophistication of health technologies, growing demands on public health and limited resources, as well as the relationships between good regulatory practices to the implementation of reliance mechanisms.
On the other hand, other resources that countries can use to move toward strengthening their health regulatory systems were mentioned, such as: WHO’s Global Tool for the Evaluation of National Regulatory Systems and PAHO’s recommendations in the Report named: “Strengthening Regulatory Systems in the Region of the Americas”.
Additionally, panelists commented the new strategies adopted to address the COVID-19 emergency, which arrived to stay, due to the practical benefit they provided: Increased communication and transparency in regulators and industry activities, virtual interactions and digitization of procedures, to name a few.
During the session, Cammilla Gomes and Leonardo Semprun highlighted the role of the pharmaceutical industry in the collaboration and dialogue between all stakeholders involved in Good Regulatory Practices and Reliance activities to help generate and build trust. “We are all partners to ensure that patients continue to have access to safe, effective and high-quality medicines.”
FIFARMA’s messages at this event are taken from: “Good Regulatory Practices in the Latin American Region” and “Considerations for the Effective Use of Regulatory Decisions in Other Jurisdictions (reliance)” by Regulatory Agencies in the Latin American Region: Industry perspective.
* The information contained in this document, is a summary of the webinar that portrays the experts’ perspective, and does not necessarily reflect the views, thoughts or opinions of FIFARMA or its members. Any content provided by our experts belongs to their opinion, and is not intended to defame any religion, ethnic group, club, organization, company, individual, nor no one or anything.