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 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.
FDA fills in the details with guidance for Marketing Status Notification

In 2017, the Reauthorization Act (FDARA) made it mandatory for drug marketing holders to notify the FDA about the status of the NDA or ANDA product withdrawal. The FDA releases guidance on how to update the FDA appropriately.
Good Manufacturing Practices Certificate (CBPF) Renewal with Brazil’s Anvisa

Every Two years in Brazil, Manufactures must renew their GMP certificate known as CBPF, incorrect petition of this renewal will lead to rejection or return.
The UK’s MHRA provides more provisions on Pharmacovigilance

UK MHRA publishes UK, (12A) to Regulation 205A, providing provisions for pharmacovigilance activities and PMSF requirements.
Whitening Cosmetics: Regulatory Requirements in China

Freckle and whitening cosmetics are mainly used to reduce skin epidermal pigmentation or help skin whitening and whitening. New regulation have been implement to have ore over site of cosmetic products and prevent serious adverse effects.
Brazil’s Anvisa produces new committee for the accelerated submission of COVID-19 related clinical trials.

Anvisa has established a Committee for Evaluation of Clinical Studies, Registration and Post-registration of Drugs for prevention or treatment of Covid-19.