Brazil’s Anvisa Classification of Personal Hygiene Products, Cosmetics & Perfumes
Understand Brazil’s Anvisa criteria for the classification of personal hygiene products, cosmetics, and perfumes.
CADIFA – Letter of Suitability of the Active Pharmaceutical Ingredient
CADIFA (letter of suitability of the active pharmaceutical ingredient) is the administrative instrument that attests the compliance of a DIFA (active pharmaceutical ingredient dossier) with the requirements of Resolution – RDC nº 359/2020.
Transfer of Ownership of Registrations at ANVISA
Understanding the Transfer of Ownership of Registrations at ANVISA. The Resolution No 233/2018, began to allow the transfer of registration ownership of products subject to Health Surveillance through commercial operations.
Brazil’s Anvisa & Medical Device Single Audit Program (MDSAP)
Good Manufacturing Practices (GMPs) x Medical Device Single Audit Program (MDSAP)
Brazil’s Anvisa Medical Device Single Audit Program
GRP Blog explains the Registration process of Medical devices and IND in Brazil with The Brazilian Health Regulatory Agency (ANVISA). New issued regulation RDC No. 751/2022 on Sept. 21, 2022 have updated the registration process.
Brazil’s Anvisa update to Medical Device Regulation RDC 751/2022: The Importance of Grouping Devices
GRP Blog explains the Registration process of Medical devices and IND in Brazil with The Brazilian Health Regulatory Agency (ANVISA). New issued regulation RDC No. 751/2022 on Sept. 21, 2022 have updated the registration process.
The US FDA releases Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products & API
On April 2023, the USFDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft guidance on “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act” that helps to prevent and mitigate drug shortage.
The US FDA’s To produce new Cosmetic Platform and Registration Requirements for Cosmetics (MoCRA)
On March 27, 2023, The Food and Drug Administration (FDA) also referred to as ‘The Agency’ announced they will no longer accept submissions into the Voluntary Cosmetic Registration Program (VCRP).
Registration Process of Medical Devices and IVDs in Brazil
GRP Blog explains the Registration process of Medical devices and IND in Brazil with The Brazilian Health Regulatory Agency (ANVISA). New issued regulation RDC No. 751/2022 on Sept. 21, 2022 have updated the registration process.
Brazil’s Anvisa changes the Importation of Controlled Drugs Regulations
Brazil’s Anvisa changes the Importation of Controlled Drugs regulations. (2023)
Anvisa Establishes New Rules for Labeling Personal Care Products, cosmetics and perfumes.
The Brazilian Health Regulatory Agency (ANVISA) issued the regulation RDC No. 752/2022 Labeling rules for Cosmetics in Brazil.
Mexico’s Cofepris and U.S FDA agree on vision for the future with 2023 implementation plan.
On February 13, 2023, COFEPRIS released Communicate No. 15/2023, a press communicating, their strategic alliance with the US FDA in the 2023. The strategy discusses primarily, The guarantee of the safety, quality, and efficacy of medicines in Mexico and the United States. Secondly, That Both authorities work on food safety for the benefit of the health of the populations of both nations.