Life sciences and healthcare
New regulation from the National Health Surveillance Agency (Anvisa) establishes a pilot project for the gradual implementation of digital drug leaflets.
Anvisa approves the National Prescription Control System to improve, to streamline the numbering and control of prescriptions for controlled-use medications.
MS publishes new rules for the Partnerships for Productive Development (PDP) program and the Local Innovation Development Program (PDIL).
Bill 6.007/23, which addresses the requirements for carrying out research with human beings in Brazil, is heading for presidential sanction.
Anvisa establishes an optimized procedure for the analysis of medical device Marketing Authorizations recognized by an equivalent foreign regulatory authority.
Ministry of Health discloses actions to comply with TCU determinations on Partnerships for Productive Development, which had been suspended.
The Brazilian healthcare system has been undergoing an intense process of digital transformation, through the application of technological tools such as AI, blockchain, IoT, and others in management processes, research & development, healthcare, and public policies.
Bill of Law No. 7.082/17 approved by the Brazilian House of Representatives addresses requirements for conducting research with human beings in Brazil.
Clinical research is conducted to discover or confirm risk factors for diseases, new therapeutic indications, adverse reactions, and/or effects of a specific therapy (including gene or cell therapy), technique, medication, and/or medical device.
Ministry of Health launches Digital Health Program in SUS to promote digital transformation in the Unified Health System and expand access to services.
The growing number of scientific studies on the therapeutic properties of Cannabis Sativa and psychedelic substances points to the need for relevant updates in Brazilian regulation.
Our eBook on the “Brazilian Regulatory Framework for Rare Diseases” is an essential guide to Brazil’s healthcare system, providing a comprehensive analysis of the regulatory processes related to rare disease medications, including gene and cell therapies.
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