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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
INDUSTRY
Vaccine COVID-19
Introduction to China's COVID-19 Vaccines More than 235.97 million doses of COVID-19 vaccines have been administered across China by Apr. 27, 2021. The country has started its mass vaccination program and plans to vaccinate 40% of its population by June this year.
Apr 29, 2021
POLICY
Marketing Approval Clinical Trial Real World Data
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
REGULATION
Law & Regulation Guideline Reference Listed Drug (RLD) CMC Clinical Trial Generic Drug API
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2021 In Mar. 2021, the Center for Drug Evaluation released a total of seven announcements including contents such as technical requirements for drug research & evaluation. ChemLinked BaiPharm team collected the documents and summarized their keynotes.
Apr 08, 2021
INDUSTRY
Marketing Approval Biological Product
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
INDUSTRY
Law & Regulation Post-market
Adverse Drug Reaction in China: Important Numbers from 2020 Report In 2020, China's National Monitoring System of Adverse Drug Reaction (ADR) received a total number of 1.676 million reports of ADR events.
Mar 31, 2021
POLICY
Law & Regulation Marketing Approval Priority Review
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
REGULATION
Law & Regulation DMF Medical Device
China Launches Medical Device Master File System On Mar. 12, 2021, China National Medical Products Administration (NMPA) announced guidance on filing medical device master files (MAFs), which specified content, format and procedures of this new MAF system. The announcement took effect on the same day.
Mar 26, 2021
POLICY
Priority Review Generic Drug
China Releases Second Batch of 17 Encouraged Generic Drugs China officially issued the Second Batch of 17 Encouraged Generic Drugs, which could benefit from preferential policy support in terms of priority review and approval, clinical trials and critical generic technology researches in China.
Mar 26, 2021
REGULATION
Clinical Trial CRO GCP Medical Device
China Rejects Medical Device Registration Applications with Data Authenticity Issues On Jan. 15, 2021, China National Medical Products Administration rejected a company’s medical device registration application because of the data authenticity issue in the clinical trial.
Mar 24, 2021
INDUSTRY
Law & Regulation Marketing Approval Innovative Drug
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
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