COFEPRIS: Self-Verification Guide for Warehouses Storing and Distributing Medicines and Other Health Supplies
Mexico’s health regulatory authority, COFEPRIS, has published a Self-Verification Guide designed for companies operating warehouses that store and distribute medicines and other health-related supplies. This initiative aims to strengthen compliance with sanitary regulations, standardize procedures, and help businesses identify nonconformities—ultimately improving safety and traceability across the supply chain.
QCC x GMP: How does the Quality Control Certificate relate to ANVISA’s Good Manufacturing Practices?
The QCC (Quality Control Certificate) is indeed associated with ANVISA’s Good Manufacturing Practices (GMP), but they are not exactly the same thing. ANVISA’s GMP (Good Manufacturing Practices) is a regulatory requirement that certifies that health product companies, such as medicines and medical devices, follow safe and effective manufacturing practices. QCC certification is a type of quality control documentation that can be used to certify compliance with ANVISA’s GMP standards, but QCC itself is more of a type of control certification and does not replace the formal GMP authorization issued by ANVISA
Brazil’s Anvisa authorizes Remdesivir for Pediatric- Use in the treatment of Covid-19
Anvisa approved, on Monday (11/21), the extension of use of the antiviral drug Remdesivir for pediatric use in the treatment of Covid-19.
Brazil’s ANVISA Approves new Normative for the Registration of New and Innovative Medicines
On October 2022 Anvisa publishes approval measures for the registration of new and innovative medicines in Brazil
Brazil’s ANVISA Announces Medical Device Registration 2022 Updates
ANVISA Brazil announced in early September 2022 important updates to its Collegiate Directorate Resolution (RDC) 185/2001.
The changes strengthen the country’s medical device registration regulations on the effective date of March 1, 2023.
Anvisa Introduces Pilot Program to Increase Quality of Health Products
Anvisa instituted the Pilot Program to Expand the Quality of the National Health Products Industries, through Ordinance 680/2020. The objective is to strengthen the industries manufacturing health products classes III and IV in the country.