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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China to Initiate Pre-Approval Inspections Based on Risk Levels of Drug Registration Applications
China will carry out pre-approval inspections on R&D and manufacturing sites involved in drug registration applications. When necessary, the inspections can extend to relevant API, excipient, packaging material manufacturers, suppliers, and contract organizations.
Dec 24, 2021
INDUSTRY
Law & Regulation
Pharmacopoeia
MAH
Pharmacovigilance
Marketing Approval
Innovative Drug
Drug Registration
New Drug
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
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Biosimilar
Drug Registration
New Drug
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
Law & Regulation
Guideline
Marketing Approval
Clinical Trial
Bioequivalence (BE)
Post-market
Drug Registration
New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | September 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 Drug
Generic Drug
Biological Product
Biosimilar
Drug Registration
New Drug
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
Law & Regulation
Pharmacopoeia
MAH
Pharmacovigilance
Marketing Approval
Innovative Drug
Drug Registration
New Drug
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