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.
China eCTD Requirements: Coming into Effect December 2021
On September 29,2021, China Health Authority (NMPA) published the technical specifications of Electronic Common Technical Document (eCTD) for the initial New Drug Application (NDA) and Biologics License Applications (BLAs) that will come into effect by December 29, 2021.
NMPA releases a final guidance on Device Master File (DMF) submissions
As per the Announcement no. 36 of 2021, lists requirements for voluntary submission of domestic Class III and imported Class II and III medical devices and IVDs.
China’s NMPA Publishes the “Cosmetic Supervision and Administration Regulation”
On June 29,2020 The National Medical Products Administration (NMPA) published a new cosmetic regulation known as the “Cosmetic Supervision and Administration Regulation”.
China’s NMPA releases new regulation on the Registration of Biologics in China
China’s NMPA releases on June 30,2020, No. 43 of 2020 to regulate biologics efficiently, NMPA has divided biologics into 3 categories.
EMA FAST TRACKS FOR MEDICINES AND VACCINES DURING COVID-19 PANDEMIC
On May 4, 2020, The European Medicines Agency (EMA) details the rapid approval procedures for COVID-19 products which includes scientific advice, rolling reviews, accelerated assessments.
Argentina’s ANMAT Requirements for Facemask Registration
Argentina’s ANMAT releases requirements for Facemaks to act as a protective barrier against Coronavirus and be elgibile for regirstration.
Anvisa’s Call Notice 2/2020 : Similar Drug Notice
On Thursday (1/30), Anvisa published Call Notice 2/2020 , aimed at requesting information on similar drugs registered in Brazil.