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Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
INTERPRETATION
How to Get China's Marketing Authorization for OTC Drugs
Sep 16, 2022
INTERPRETATION
How to Sell OTC Drugs to China via Cross-Border E-Commerce
Sep 16, 2022
Q&A
China CDE Q&A | Biologics' R&D, Associated Review of APIs, Excipients, and Packaging Materials, Requirements for Changes, and More
Sep 05, 2022
Q&A
China CDE Q&A | BE Study, Reference Listed Drug, and Quality & Therapeutic Equivalence Evaluation
Aug 30, 2022
INTERPRETATION
How to Get Drug Marketing Authorization Holder (MAH) Agency Services in China
Aug 26, 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
Leading Contract Research Organizations (CRO) in China
May 31, 2022
INTERPRETATION
China Abbreviated New Drug Application (ANDA) for Generic Drugs
May 18, 2022
Q&A
FAQ on Rare Disease Drugs (Orphan Drugs) in China
Apr 07, 2022
INTERPRETATION
Drug Application Fees for FY 2022 in China and the U.S.
Feb 11, 2022
INTERPRETATION
China's Marketing Authorization Holder (MAH) System
Nov 25, 2021
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