Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
China Cracks Down on Monopolies in Active Pharmaceutical Ingredient Industry On Nov. 18, China issued the Anti-Monopoly Guidance for Active Pharmaceutical Ingredients, clarifying regulations against monopoly agreements, abuse of market power, and concentration of undertakings in the API industry.
Nov 26, 2021
Laws & Regulations Pharmacopeia MAH Pharmacovigilance Marketing Approval Innovative Drugs Drug Registration New DrugsCRAC-HCF 2021 | Embracing China's Pharma Market With Regulatory Compliance and Industry Insights Five experts from drug regulation authorities, pharmaceutical companies, and consulting firms decoded drug regulations and analyzed industry dynamics for international pharma companies to develop businesses in the Chinese market.
Nov 17, 2021
Monthly Recap: China Pharmaceutical Regulatory Updates | Oct. 2021 China’s Pharma Regulatory Dynamics in Oct. 2021 1. NMPA Releases IVD Reagent Classification Rules 2. NMPA Greenlights 195 Medical Devices 3. NMPA Publishes Medical Device’s Self-Inspection Rules 4. NMPA Rolls Out the 45th, 46th, and 47th Batches of Reference Listed Drugs 5. NHC Consults on Detailed Rules on the Supervision of Internet-based Diagnosis 6. CDE Releases Pharmaceutical Guidelines
Nov 11, 2021
NMPA-Approved Injectable Fillers in China's Market China’s promising injectable filler market is expected to witness other new products' emergence. The market size is predicted to grow from US$ 603.8 million in 2019 to US$ 1,063.53 million by 2026. Meanwhile, China tightens the regulation on aesthetic medical products or practices so injectable fillers and relevant businesses won’t be an exception.
Nov 04, 2021
Laws & Regulations CDE Guidance Marketing Approval Clinical Trials Bioequivalence (BE) Post-market Drug Registration New DrugsMonthly Recap: China Pharmaceutical Regulatory Updates | Sept. 2021 1. China's eCTD Format for Drug Marketing Application Dossiers; 2.1. NMPA Underlines Points for Attention on Implementing Administrative Measures for Medical Device Registration and Filing and Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing. 2.2. NMPA Rolls Out the List of Medical Devices Exempted from Clinical Evaluation3 and the List of In Vitro Diagnostic Reagents Exempted from Clinical Trials; 2.3. NMPA Releases Format Requirements for Medical Devices’ or IVD Reagents’ Registration Application Dossiers and Approval Documents; 2.4. Guidelines on Medical Devices and IVD Reagents; 2.5. NMPA Releases Medical Device Industry Standards; 2.6. NMPA, NHC and NHSA Stipulates Unique Device Identifiers; 3. NMPA granted Aloe Vera Pearl Capsules OTC Status; 4.A Collection of Sept. Guidelines Released by NMPA or CDE
Oct 31, 2021
Laws & Regulations Pharmacopeia MAH Pharmacovigilance Marketing Approval Innovative Drugs Drug Registration New DrugsOnline Conference | China Drug Regulation and Pharmaceutical Market BaiPharm will hold a virtual conference on Nov. 12, as part of the CRAC-HCF 2021 event. We will have five speeches elaborating on China drug regulations and pharmaceutical market. The specific topics include China market entry strategy, Chinese Pharmacopoeia, GVP, MAH, and innovative drug research.
Oct 21, 2021
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
- Online Conference | China Drug Regulation and Pharmaceutical Market
- China Cracks Down on Monopolies in Active Pharmaceutical Ingredient Industry
- Monthly Recap: China Pharmaceutical Regulatory Updates | Sept. 2021
- Monthly Report: New Drug Approvals in China | Sept. 2021
- China Chemical Drug Registration Classification