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.
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
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
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.
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.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 Announces Electronic versions of Drug & API Export Certificates are now available (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.
FDA-Advancing Real World Evidence Program
In October 2022, the U.S. Food and Drug Administration is announcing the Advancing Real-World Evidence (RWE) Program