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 […]
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.
China’s NMPA issues four technical guidelines for bioequivalence studies of specific varieties
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) ⟩”
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.
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”.
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On May 9, 2022, The General Department of the National Medical Products Administration (NMPA) issued draft guidance on Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China.
A Local Agent in China is legal representative of overseas pharmaceutical and medical devices companies required as per the NMPA regulations.
China’s CDE- Guidelines for Summary of Adverse Drug Reaction Data in Labeling of Antineoplastic Drugs
China’s CDE issued on March 21st, 2022 the guidelines for the listing Adverse reaction in package inserts.
On March 31, China NMPA and NHC released an updated version of Good Clinical Practice (GCP) regulation for Medical Devices (announcement 28, 2022), that will take effect on May 1, 2022.
China’s CDE releases Draft Technical Guidelines on the Study Conditions of Dissolution Curves in the Study of Marketed Chemical Drugs
On March 14, 2022, China’s CDE released the “technical guidelines for clinical trials of new chemical enhanced drugs
GRP’s Special program for Accelerated Market Access to China is offered to Foreign Pharmaceutical, Biotech and MedTech companies that have innovative products that are already approved in USA and/or EU or Japan