Brazil’s Anvisa changes the Importation of Controlled Drugs Regulations
Brazil’s Anvisa changes the Importation of Controlled Drugs regulations. (2023)
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.
Mexico’s Cofepris and U.S FDA agree on vision for the future with 2023 implementation plan.
On February 13, 2023, COFEPRIS released Communicate No. 15/2023, a press communicating, their strategic alliance with the US FDA in the 2023. The strategy discusses primarily, The guarantee of the safety, quality, and efficacy of medicines in Mexico and the United States. Secondly, That Both authorities work on food safety for the benefit of the health of the populations of both nations.
Brazil’s Anvisa Updates Medical Device Regulations with RDC 751/2022.
The Brazilian Health Regulatory Agency (ANVISA) issued the new medical device regulation RDC No. 751/2022 on Sept. 21, 2022.
The U.S FDA Announces Pilot Program for Medical Device Submission with Health Canada
Overview On January 2023, the FDA announced that it has partnered with Health Canada to launch a joint eSTAR pilot. The pilot will allow medical device manufacturers to submit a premarket notice submission to FDA and Health Canada simultaneously. Introduction The eSTAR is an interactive PDF form that helps guide applicants through the medical device […]
The US FDA Updates Meeting Procedure for under PDUFA VII and BsUFA III
Starting February 2023, The US FDA Updates Meeting Procedure for under PDUFA VII and BsUFA III
China’s CMDE Drafts Guidelines for the Registration of Implantable Medical Devices
On January 2023, the CMDE issued Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries.
US FDA Issues Rule to Streamline Radiological Health Regulations
On January 2023, The U.S. Food and Drug Administration (FDA) published Radiological Health Regulations for Recording and Reporting Radiation Emitting Electronic Products and Performance Standards for X-ray, Laser and Ultrasonic Diagnostic Products.
US FDA Proposes Fee Increases for Certification Services on Color Additives
On January 2023, The U.S. Food and Drug Administration (FDA) has issued a proposed rule to amend color additive regulations to increase fees for certification services. ves
China’s NMPA issues more Technical Guidelines for Bioequivalence Studies
China’s NMPA issues four technical guidelines for bioequivalence studies of specific varieties
China’s NMPA Announces Good Practices for Review Timelines During the Drug Evaluation Process
China’s NMPA Announces Good Practice for Timing Termination and Restoration of Review in the Process of Drug Evaluation
Japan’s MHLW Publishes New Quality Standards for Quasi-Drugs
On October 2022, the Japanese Ministry of Health, Labour and Welfare (MHLW) has published new quality standards and specifications of 2,647 ingredients and additives that can used in Quasi-drugs.