Greater Rigor and Safety: ANVISA’s New Guidelines for Impurities and Degradation Products in Medicines
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
The Shadow of Irregularity: Unregistered Medicines and Hair Cosmetics and the Hidden Risks
This Blog addresses the intensified inspection efforts by the Brazilian Health Regulatory Agency (ANVISA) against the marketing of products without proper sanitary authorization. We analyze recent seizure cases involving Unregistered Hair Cosmetics (Botox and Straightening products) and Irregular Medicines/Herbal Supplements, highlighting how the absence of registration, notification, or proper listing exposes consumers to serious health risks and the industry to severe penalties.
China’s NMPA Releases draft on the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China.
On May 9, 2022, The General Department of the National Medical Products Administration (NMPA) issued draft guidance on Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China.
China’s NMPA: Local Agent in China for Foreign Pharmaceutical and Medical Device Companies
A Local Agent in China is legal representative of overseas pharmaceutical and medical devices companies required as per the NMPA regulations.
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