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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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Pharmacopeia
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Innovative Drugs
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CRAC-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
REGULATION
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
INDUSTRY
Marketing Approval
Priority Review and Approval
Innovative Drugs
Generic Drugs
Biological Products
Biosimilars
Drug Registration
New Drugs
Monthly Report: New Drug Approvals in China | Oct. 2021
In Oct. 2021, China's NMPA granted marketing authorization approvals to 11 new drugs, including Takeda's VOCINTI and Sanofi's Clopidogrel Bisulfate and Aspirin Tablets.
Nov 08, 2021
REGULATION
Laws & Regulations
CDE Guidance
Marketing Approval
Clinical Trials
Bioequivalence (BE)
Post-market
Drug Registration
New Drugs
Monthly 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
INDUSTRY
Marketing Approval
Innovative Drugs
Generic Drugs
Biological Products
Biosimilars
Drug Registration
New Drugs
Monthly Report: New Drug Approvals in China | Sept. 2021
In Sept. 2021, China's NMPA granted 13 new drug approvals, including for Sanofi-Aventis Groupe's Dupilumab Injection and Merck's Pembrolizumab Injection.
Oct 25, 2021
INDUSTRY
Laws & Regulations
Pharmacopeia
MAH
Pharmacovigilance
Marketing Approval
Innovative Drugs
Drug Registration
New Drugs
Online 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
REGULATION
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
REGULATION
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
INDUSTRY
Marketing Approval
Priority Review and Approval
Innovative Drugs
Generic Drugs
Drug Registration
New Drugs
Monthly 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
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