The Collegiate Board of the Brazilian Health Regulatory Agency (ANVISA) has announced an important update to the rules for the registration and importation of medications and vaccines aimed at combating Mpox, formerly known as monkeypox. The measure aims to streamline the regulatory process, facilitating access to treatments and vaccines, especially during outbreaks and public health emergencies.
This regulatory update represents a significant advancement as it seeks to eliminate bureaucratic obstacles without compromising the safety and efficacy of products. With this, ANVISA aims to ensure that the necessary products for combating Mpox reach the population more quickly, strengthening Brazil’s response to this global threat.
Among the key changes is the expansion of the applicability of the flexible rules, which were previously intended for medications and vaccines in specific situations. Now, this simplification will apply to a broader range of products, allowing innovative treatments and emergency solutions to be approved in record time.
Additionally, the regulation includes guidelines that facilitate the importation of products already authorized by other renowned international regulatory agencies. This means that medications and vaccines already approved in international markets can be more quickly accessible in Brazil, provided they meet the quality criteria established by ANVISA. This decision reflects the agency’s commitment to ensuring public health in Brazil, while adopting a swift and efficient approach to responding to new global health demands.
For more details on this regulatory update and its impact on the healthcare market, visit ANVISA ‘s website and stay informed about the latest regulatory news. For further information, contact Brisa Advisors for specialized regulatory support.
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