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 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
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
US-FDA Publishes New Requirements for OTC Drugs Labeling
On September 8,2022, FDA published the draft of a guideline that provides recommendations on the labeling of OTC drugs.
FDA publishes product-specific guidances to facilitate generic drug development
FDA publishes product-specific guidance’s to facilitate generic drug development.
Overview of generic drug registration with USFDA
Drug companies must submit an abbreviated new drug application (ANDA) to FDA for approval to market a generic drug.
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
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.
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.