INSIGHTS China DMF Filing, Review & Approval System for APIs, Pharmaceutical Excipients & Packaging Materials
In all critical stages in the drug life cycle, BaiPharm can provide specific recommendations and actionable solutions to clients.VIEW MORE >
Consulting of current regulation and policy
NMPA related application for clinical trial and marketing approval
Compliance support from product development to commercialization
Post-market drug safety and risk management
China to Accept eCTD Format for Marketing Authorization Applications for Specific Classes of Drugs China will start to accept the eCTD format for drug applications on Dec. 29, 2021 while still allowing drug applicants to stay with the current method—submitting compact disks containing dossiers.
Oct 14, 2021
New IVD Reagent Registration and Filing Rules Take Effect in China 1. The Measures’ Application Scope; 2. Definition of IVD Reagents in China; 3. IVD Reagent Classification in China; 4. Definition and Application Scope of IVD Reagent Registration/Filing in China; 5. Qualification of Registration/Filing Applicant and Local Agent; 6. Competent Authority to Submit Application/Documentation to; 7. Documentation for IVD Reagent Registration Application/Filing; 8. Special Approval for IVD Reagents; 9. Product Change and Certificate Validity Extension; 10. Adjusting the Class of Registered IVD Reagents.
Oct 08, 2021
Monthly Recap: China Pharmaceutical Regulatory Updates | Aug. 2021 1. NMPA Releases the 44th Batch of Reference Listed Drugs; 2. SAMR to Enforce New Rules for Medical Device and IVD Reagent Registration/Filing; 3. NMPA Announces Four Rx-to-OTC Switches...
Sep 30, 2021
China to Exempt Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials On Sept. 18, the National Medical Products Administration (NMPA) released the List of Medical Devices Exempted from Clinical Evaluation and the List of In Vitro Diagnostic Reagents Exempted from Clinical Evaluation. Both are scheduled to take effect on Oct. 1, 2021.
Sep 24, 2021
Marketing Approval Priority Review and Approval Innovative Drugs Generic Drugs Drug Registration New DrugsMonthly Report: New Drug Approvals in China | Aug. 2021 In Aug. 2021, China NMPA nodded for nine new drug products including Tislelizumab Injection, Apremilast Tablet and Nivolumab Injection.
Sep 14, 2021