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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
POLICY
Marketing approval Clinical Trials
Clinical Real-World Data Pilot Program: Fast-Track Entry Pathway into China It usually takes at least three to five years for innovative new medical products to enter the Chinese market. However, procedure could be much shorter with the application supported by clinical RWD.
Apr 12, 2021
INDUSTRY
Marketing approval Biological Products
Rapid Growth of Botulinum Toxin in China's Aesthetic Medicine Market With the major function to reduce the appearance of skin wrinkle, botulinum toxin injection has become one of the most favorable aesthetic medicine products by Chinese customers.
Apr 07, 2021
POLICY
Laws & Regulations Marketing approval Priority Review and Approval
Drugs Marketed in Hong Kong Are Expected to Supply Patients Across the Greater Bay Area Soon Patients in the Greater Bay Area can soon have access to the marketed drugs in Hong Kong's public hospitals.
Mar 29, 2021
INDUSTRY
Laws & Regulations Marketing approval Innovative Drugs
Ophthalmic Drug Market in China Attracts Increasing Attention In recent years, incidence rates of diseases like myopia, cataract, and dry eye syndrome have been growing year by year for all age groups in China.
Mar 22, 2021
REGULATION
Laws & Regulations CDE Guidance Marketing approval CMC Generic Drugs APIs
China Announces Technical Requirements for Overseas Approved Chemical Drugs Seeking Domestic Marketing Authorization On Mar. 8, China Center of Drug Evaluation issued the Technical Requirements for CMC Studies and Evaluation of Overseas-approved Chemical Drugs without Domestic Marketing Authorization (Trial).
Mar 09, 2021
REGULATION
Laws & Regulations Marketing approval Clinical Trials Priority Review and Approval
China CDE to Disclose New Drugs' Technical Review Reports China's Center of Drug Evaluation (CDE) recently announced that it would disclose the technical review reports and package inserts of all new drugs approved since Sept. 1, 2016. The disclosure would also extend to generic drugs and other applications in the future.
Feb 24, 2021
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