New historical and regulatory milestone for cannabis in Brazil: ANVISA publishes new RDCs (Collegiate Board Resolutions) and advances the regulation of medicinal cannabis.
The Collegiate Board Resolutions (RDC) No. 1,011/2026, No. 1,012/2026, No. 1,013/2026, No. 1,014/2026, and No. 1,015/2026 were published in the Official Gazette of the Union, establishing provisions on cannabis regulation in Brazil.
Exports of Medicines Temporarily Suspended to Ensure National Supply
The National Medicines and Health Products Authority (Infarmed) has updated the list of medicines whose export is temporarily banned. The new version includes eight more drugs than the previous month’s and covers essential medicines used to treat heart failure, osteoporosis, psychiatric disorders (antipsychotics), pain (analgesics) and bacterial infections (antibiotics).
Anvisa promotes direct consultation on new regulatory framework for medical devices
The National Health Surveillance Agency (Anvisa) has announced the opening of a targeted consultation on the new proposal for a federal regulatory framework for medical devices. The initiative will be launched at a virtual event on May 13, at 9am (Brasília time), via the Microsoft Teams platform.
Public Consultation on Medicinal Cannabis Products: Anvisa’s Main Proposals
As of April 4, 2025, Anvisa launched a public consultation (CP 1.316/2025) to update the rules on cannabis products for medicinal use in Brazil.
Anvisa publishes new resolution on Good Manufacturing Practices for Medicines
Anvisa (National Health Surveillance Agency) published Collegiate Board Resolution (RDC) No. 972/2025 in the Federal Official Gazette last Wednesday, April 23, 2025. The new text updates RDC 658/2022, which establishes the General Guidelines for Good Manufacturing Practices for Medicines in Brazil.
Public Consultation on the Revision of RDC 327/2019: Main Changes and Criticisms
On March 26, 2025, the public consultation on the revision of RDC 327/2019, which regulates the health authorization, manufacture, import, marketing, prescription and inspection of cannabis-based products for medicinal purposes in Brazil, was approved.
Decree-Law No. 23/2025: New Rules for Cosmetic Products in Portugal
Decree-Law no. 23/2025 has been published, ensuring the implementation of Regulation (EC) no. 1223/2009 on cosmetic products. The decree comes into force on March 24, 2025 and establishes new rules to guarantee the safety of cosmetics on the Portuguese market.
Anvisa Returns to Publishing Medical Device Price Monitoring Data
Anvisa (the National Health Surveillance Agency) has announced the resumption of the publication of medical device price monitoring data in its Business Intelligence (BI) panels. The activity, which had been temporarily suspended, is now back, with improvements to the process and guarantees of greater efficiency and precision.
ELS Group Named Finalist for the 2025 Sindusfarma Quality Award in Two Categories
ELS Group has been selected as a finalist for the 2025 Sindusfarma Quality Award in Quality Control Consulting and Storage & Distribution of Medicines. This recognition highlights the company’s expertise and commitment to excellence in the Brazilian pharmaceutical sector.
EMA and HMA Present Strategy for Medicines Regulation in the European Union until 2028
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) recently unveiled the new European Medicines Agency Network Strategy to 2028 (EMANS 2028), a document that outlines the priorities for medicines regulation in the European Union in the coming years. This strategy aims to respond to the challenges and needs of the pharmaceutical sector and strengthen the EU’s competitiveness in the development and manufacture of medicines, while ensuring safe and equitable access to innovative treatments.