China’s CDE Releases guidance for the Technical requirements of Generic injections
China’s CDE releases guidance on the Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Injections
Brazil’s ANVISA outlines reasons for the approval and rejection of registration of synthetic drugs.
Anvisa presents the reasons for the approval and rejection do generic drugs and how companies should proceed in order to register successfully with the Health Authority.
Food Supplements in Latin America : Market overview and Regulations
Latin America is becoming a land of opportunity for many emerging markets and Food Supplements are rapidly becoming more popular in the LATAM region.This blog will overview Brazil, Mexico and Argentina Market potential for food supplements and relevant regulation specific to each region.
China’s NMPA announces Delay of Unique Device Identification (UDI) Implementation
Due to the Coronavirus, Chinese Regulatory Authority, National Medical Products administration (NMPA). decided to delay UDI implantation to next year January 2021.
Brazil’s Anvisa updates requirements for Good Distribution and Storage Practices Certification (CBPDA) for Health Products
Anvisa changes the list of documents for Good Distribution and Storage Practices Certification petitions for health products.
Brazil’s Anvisa publishes guide about cyber security in medical devices
Anvisa publishes Guide 38/2020, “Principles and Practices of Cyber Security in Medical Devices”. The document is intended for anyone interested in ensuring the safe use of medical devices and will be useful for users of such equipment, patients, manufacturers, distributors, health services and researchers in the area of safety
Registration of Biologics in Mexico : Frequently asked Questions
GRP Blog breaks down frequently asked regulatory questions pertaining to biologic registration in Mexico with Health Authority COFEPRIS
Brazil’s Anvisa Announces New Medical Device Regulations
On September 18,2020 Brazil’s Anvisa published the RDC no. 423/2020 which deals with the extinction of the registration and migration of medical devices of risk class II to the notification regime.
China’s CDE publishes draft for a list of Drugs exempt from BE Studies
China’s CDE publishes draft listing 117 drugs that will be exempt from BE studies.
Brazil’s Anvisa establishes New Standards on label warnings and formulas
Brazil’s Anvisa new standards require companies to warn about formula changes in products subject to health surveillance.
China’s NMPA Addresses Common Period Risk Evaluation Report (PRER) Issues
China’s NMPA updates and address some common issues faced by the Marketing Authorization Holders to submit PRER report.
China’s NMPA resolves issues regarding current administration on drug distribution
NMPA announces a new revised Drug Administration Law of the People’s Republic of China effective since Dec 1, 2019.