National regulatory systems play a key role in a country’s health system by overseeing the safety, quality, and efficacy of all health technologies, such as drugs, vaccines, blood, blood products, and medical devices. . During the pandemic, regulatory activity suffered an acceleration in its processes due to the emergency, but in many cases they could be sustained over time to take advantage of it.

In this regard, Leonardo Semprun, from the Global Regulatory Plicy at MSD, shared during the 19th Latin American Seminar on Science and Health Journalism, in Buenos Aires, Argentina, that in times of pandemic, regulatory agencies began to take on a lot of relevance and we understood how these areas accompany innovation permanently and throughout the product life cycle: research, development, licenses, marketing and post-marketing.

Initially this was understood as something very scientific and complex, but it became public knowledge, since the momentum achieved with the pandemic is that local regulatory systems seek to adapt more fluidly to international standards and streamline.

As in any crisis, the acceleration of innovation is very important, “at this point our tolerance to make decisions with a higher level of risk, the urgency for action and focused resources are essential to achieve this task, as well as regulatory activities they began to introduce new ways of working to ensure greater efficiency. It should be noted that these new ways of working did not compromise the principles of a regulator, which are drug safety, efficacy and quality”.

There are new ways in decision making, harmonization and collaboration for transparency and how evidence is presented, for example Reliance.

Reliance to strengthen regulatory systems in Latin America

National Regulatory Authorities (NRAs), with varying degrees of maturity, are increasingly using Reliance around the world. This concept is actively promoted by organizations such as the World Health Organization (WHO) and the Pan American Health Organization (PAHO) as a mechanism for NRAs to better manage resource capacity issues while strengthening systems. of regulation.

According to the Latin American Federation of the Pharmaceutical Industry, Reliance is defined as the act by which the NRAs of a jurisdiction can take into account and give significant weight to the evaluations carried out by another NRA or trusted institution, or to any other authoritative source of information, to make their own decisions. The authority using this information remains independent and accountable for decisions made, even when based on the decisions and information of others.

It is based on good regulatory practice and provides a process for sound and efficient regulation of medical products. In recent years, regulators in Latin America and the Caribbean have been implementing more and more different Reliance pathways.

In an interview for El Economista, Semprun explains that the main challenges of Reliance are associated with having a robust regulatory system and that good practices work well, that is, that they are a flexible, predictable, coherent system, with clear and objective regulations; “That no substantive and legal modifications have to be made to implement the mechanism because you recognize, consider and take into account the decisions for your own processes.”

He said that the important thing is that this is supported by a system that has circular resolutions and operating procedures that allow all those paths in regulatory matters.

“In Latin America there is a good adoption, at the level of regulators an awareness has been created about the importance of Reliance, which is something that comes with the endorsement of the WHO, who has dictated good regulatory practices. OPS has also worked on technical tables with different agencies”, including Cofepris. For its part, the industry has worked on positions to clarify concepts, where it adds value and works together.

He adds that in Mexico since the beginning of the year an operation was carried out to implement Reliance in some stages and processes, “in addition, equivalence agreements have been in place in the country for some time, that is, recognizing the decisions of high surveillance agencies. All this will allow you to be more effective in your processes and it would be very valuable to hear your news”.

Although this process was somewhat accelerated by the health emergency, at the same time it highlighted the need for agile decision-making by health authorities around the world, to continue working on the benefits of Reliance, but also the disadvantages that until now limit the effectiveness of these tools.

Mexico, part of the ICH

Another of the tools mentioned by Semprun as a promoter of best practices is to be aligned with the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products for Human Use, better known as ICH (for its acronym in English), this is an entity Unique in bringing together regulatory authorities and the pharmaceutical industry to discuss the scientific and technical aspects of pharmaceuticals and develop guidelines, it emerged in 1990 and has gradually evolved to ensure that safe, effective and high-quality medicines are developed, registered and maintained. in the most efficient way.

Mexico was accepted as a member of this highest regulatory forum in November 2021. In the Americas region, only Canada, the United States and Brazil are part of it. After acceptance by the assembly, Mexico became the fourth country on the continent to be a member and the first Spanish-speaking nation.

Membership was considered by the Federal Commission for the Protection against Sanitary Risks (Cofepris) as a priority strategy, since it helps standardize regulation, surveillance and the development of technical-scientific guides. According to the Mexican authorities, having membership would also contribute to promoting public health by improving access and availability of resources for patients.

According to the interviewee, by integrating Mexico “it will gradually become a benchmark organization, it will evolve, because by complying with all the performance indicators, there is a standard that cannot be lowered.”

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