Life sciences and healthcare
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...
Businesses have up to 180 days to comply with the new rules. To understand what changes, download our exclusive publication on the topic and stay updated with the latest guidelines in the healthcare sector.
Anvisa updates regulation on medical devices and opens public consultation on the use of analyzes performed by AREE.
Anvisa approves regulation that allows the remote delivery of controlled drugs, including through public health programs.
Anvisa RDC 811/23 reduces to 45 days the deadline to analyze whether requests for drugs registration should be classified as priorities.
On September 26, 2023, the Ministry of Health (“MoH”) announced the new strategy for strengthening the health economic industrial complex, applicable to medicines, APIs, vaccines, diagnostic reagents, treatments and health services (“New CEIS Policy”). The Brazilian government estimates R$42.1 billion in investments (new Growth Acceleration Program - “PAC” for the CEIS, via public and private funding).
TCU recommends the Ministry of Health suspend new PDPs and gives a deadline for the agency to establish a schedule for calculating the value of tech transfers
medical advertising rules, Federal Council of Medicine, ethical rules for publicity and medical advertising, defines medical advertising, use of patients’ images, Commission for the Disclosure of Medical Affairs
