Japan’s PMDA implements Surprise GMP inspections at manufacturing facilities
On July 2021, Regulators in Japan announced they will start conducting inspections by surprise at facilities where drugs, pharmaceuticals and medical devices products are manufactured
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.
The Medical Device Single Audit Program (MDSAP) has published a new consolidated guidance
On October of 2020, The Medical Device Single Audit Program (MDSAP) has published a new consolidated guidance document called, MDSAP AU P0002.005 Audit Approach.
China’s NMPA Drafts new Regulations on Patent Linkages
China’s Patent Linkage Measures is a draft policy addresses market approval of generic drugs and the patent status of branded equivalents.
Brazil’s Anvisa Certificate of Good Manufacturing Practices
The Certificate of Good Manufacturing Practices is the document issued by Anvisa attesting that a certain establishment complies with Good Manufacturing Practices.
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
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.