Since the beginning of this year, the Federal Executive has been working, led by the Executive Group of the Economic-Industrial Health Complex (GECEIS) – established by Decree 11,464/2023, to strengthen the domestic production of essential items for the Unified Health...
Pharma
ANVISA’s Innovation Policy Established by Ordinance 1,100/2023
On October 2, 2023, Ordinance 1,100/2023 was published, establishing ANVISA's Innovation Policy. This measure aims to enhance the agency's ability to address complex and unforeseen challenges while promoting the development and adoption of innovative products and...
Public Consultation for the Modification of the Biosimilars Regulation
On October 4, 2023, ANVISA published Public Consultation 1,206/2023 regarding the amendment of the current biosimilar drug regulation. This Public Consultation was approved during a meeting of ANVISA´s Collegiate Board (DICOL) held on September 27, 2023, with the aim...
Brazilian DPA releases note on privacy compliance in the pharmaceutical sector
On May 11, the Brazilian Data Protection Authority (ANPD) issued a technical note regarding the compliance practices for organizations in the pharmaceutical sector. The document is the result of a study on the privacy policies of pharmaceutical groups of economic...