The new policy is aimed at raising the regulatory systems to a level of maturity three or higher and that responds to global standards, a process that requires time and resources and a sustained commitment, according to the text.
Cuba’s First Deputy Minister of Public Health, Tania Margarita Cruz Hernández, who heads Cuba’s delegation to the meeting of PAHO’s highest authority, highlighted the work of that organization in the development of regulatory capacities.
The Cuban expert acknowledged that the proposal, is a useful and pertinent document in the current context and responds to issues discussed in previous evaluations with regulatory authorities of the countries of the region.
She also considered it positive that the proposal covers medicines and vaccines, as well as medical devices and blood derivatives, products that are subject to regulation and on which work is also being done on the global evaluation tool, as evidence of the importance of strengthening the regulation of all health technologies.
Regulatory systems are an essential component of the health system, responsible for regulating and controlling medical products so that they meet safety, efficacy and quality standards, as well as promoting equitable access and contributing to economic and social development.
They also have the purpose of ensuring measures for the health needs and the quality, safety and efficacy of health technologies according to PAHO and WHO recommendations.