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.