The Guangdong-Hong Kong-Macau Greater Bay Area (GBA) Center for Drug Evaluation and Inspection, under the National Medical Products Administration (NMPA), has announced the commencement of filing guidance services for pharmaceutical R&D entities within the GBA. This initiative aligns with the Drug Registration Regulation, aiming to offer technical guidance, facilitate communication, expedite resource allocation, and shorten evaluation timeframes for drug development and registration.
The service is designed to provide pre-filing and filing communications and guidance, ensuring a smoother registration process. As per the recent notice, GBA-based applicants proposing Class 1 novel drug investigational new drug (IND) filings, as well as Hong Kong and Macao applicants registering in mainland China, can now request guidance on a range of submission aspects, including acceptance, pharmacy, pharmacology and toxicology, statistics, clinical pharmacology, and clinical orientation.
The GBA Center will review the applicants’ submissions and offer guidance on potential filing defects. Applicants can submit their appointment materials and filing guidance application forms to [email protected]. Upon receiving an email appointment, the GBA Center will confirm the application’s eligibility and provide feedback within one working day. Applicants must then print, stamp, and submit the application form, along with accompanying CD or paper materials, via their chosen submission method.- Flcube.com
