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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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PIPELINE
Are Cross-Border Licensing Deals a Shortcut to China's Pharma Market?
In 2021 H1, China has made 50 in-licensing deals, among which the top 10 add up to $5,197.5 million in value. Licensing deals do have advantages for promoting foreign drugs in China, but they are not shortcuts. Prudent work still needs to be done before making the deals.
Dec 07, 2021
POLICY
China's Insulin VBP Sees Average Price Cut of 48.75%
China’s insulin VBP (volume-based procurement)--eleven drug makers won the bid to supply insulin products to public healthcare institutions across China. Among 42 bid-winner products, Novo Nordisk took the champion with seven products. Two local Chinese companies—Gan & Lee and the United Laboratories—took the second and third places with six products respectively.
Dec 06, 2021
REGULATION
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
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
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | October 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
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
INDUSTRY
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
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
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