Pharmaceutical
ChemLinked
Market
Chemical
Food
Cosmetic
Pharmaceutical
Japan
Agrochemical
Sustainability
LOG IN
SIGN UP
LOG IN
Home
News
Insights
Database
Events
Webinars
Offline Events
Services
Home
News
Insights
Database
Regulatory Database
Drug Catalog
ChP Standards
Events
Webinars
Offline Events
Services
Search
Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
All
Interpretation
Report
Q&A
All
Interpretation
Report
Q&A
Topic
Regulation
Guideline
Law & Regulation
Pharmacopoeia
Reference Listed Drug (RLD)
Hot topic
Bioequivalence (BE)
Clinical Trial
CMC
CRO
DMF
Drug Registration
E-commerce
GCP
GLP
GMP
GSP
License in/out
MAH
Marketing Approval
New Drug
Pharmacovigilance
Post-market
Priority Review
Real World Data
Policy
Health Insurance
NRDL
Volume-based Procurement
Product
API
Biological Product
Biosimilar
Excipient
Generic Drug
Innovative Drug
Medical Device
OTC Drug
Packaging
Pediatric Drug
Vaccine
Apply
Cancel
Generic Drug
REPORT
2022 China CDE Drug Evaluation Report
Sep 21, 2023
INTERPRETATION
For Injectable Complex Generics, China Has Special CMC Requirements
May 11, 2023
INTERPRETATION
[Updated] Drug Application Fees for FY 2023 in China and the U.S.
Feb 10, 2023
INTERPRETATION
Comparing First Generic Drugs in China and the US
Nov 25, 2022
INTERPRETATION
How to Get China's Marketing Authorization for OTC Drugs
Sep 16, 2022
Q&A
China CDE Q&A | BE Study, Reference Listed Drug, and Quality & Therapeutic Equivalence Evaluation
Aug 30, 2022
Q&A
China CDE Q&A | Drug Registration Applications & Clinical Trials
Aug 08, 2022
REPORT
2021 China CDE Drug Evaluation Report
Jul 04, 2022
INTERPRETATION
China Abbreviated New Drug Application (ANDA) for Generic Drugs
May 18, 2022
INTERPRETATION
China Chemical Drug Registration Classification
Oct 18, 2021
REPORT
China Drug Evaluation Report 2020-Disapproval Reasons
Aug 27, 2021
REPORT
China Drug Evaluation Report 2020-Critical Numbers
Aug 27, 2021
1
2
Next
Name
*
Company
*
Email
*
Message
*
Cancel
Get in Touch Now