China’s NMPA issues more Technical Guidelines for Bioequivalence Studies
China’s NMPA issues four technical guidelines for bioequivalence studies of specific varieties
FDA Adding Common Ingredient to the Major Food Allergen List Starting
On January of 2023, the U.S. FDA added sesame to the official list of major food allergens, as identified by the Food Allergen Labeling and Consumer Protection Act of 2004, that includes milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans.
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.
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
China’s NMPA issues Notice on Technical Guidelines for Change Studies of Marketed Chemical Drugs
On November 8, 2022, the CDE issued a notice on “Questions and Answers for Dissolution Profile Studies ⟨Technical Guidelines for Pharmaceutical Change Studies of Marketed Chemical Drugs (Trial) ⟩”
CHINA’S NMPA NEW REQUIREMENTS FOR SODIUM HYALURONATE
On November, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
China’s NMPA Announces Electronic versions of Drug & API Export Certificates (2022)
On December 2022, a new template Drug Export Sales Certificate has been launched, which conforms to the format recommended by the World Health Organization (WHO). Electronic certificates have the same effect as paper certificates.
China’s NMPA Announces Guidance for Good Operating Practices for Medical Devices
On November 2022, the NMPA issued the Announcement on “Appendix to Good Operating Practices for Medical Devices: quality Management of Enterprises Providing Transportation and Storage Services for Medical Devices”.
USFDA Publishes updated definitions FOR ‘Face-to-Face Meeting’
The FDA publishes updated Definitions of Face‑to‑Face Formal Meetings.
Brazil’s ANVISA Approves new Normative for the Registration of New and Innovative Medicines
On October 2022 Anvisa publishes approval measures for the registration of new and innovative medicines in Brazil
FDA-Advancing Real World Evidence Program
On October 2022, the U.S. Food and Drug Administration is announcing the Advancing Real-World Evidence (RWE) Program