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Consulting of current regulation and policy
NMPA related application for clinical trial and marketing approval
Compliance support from product development to commercialization
Post-market drug safety and risk management
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2022 Check out the pharma regulatory updates in China: The 7th National Volume-based Procurement (VBP) Includes 327 Drug Products; China CDE Consults on Procedures for Starting For-cause Inspections; China CDE Releases Q&A on Immediate Report of Adverse Drug Reactions in Clinical Trials...
Aug 05, 2022
Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Drug Registration New Drug COVID-19Monthly Report: New Drug Approvals in China | July 2022 In July 2022, China NMPA approved 10 new drugs, including 8 chemical drugs and 2 biological products. Among the drugs, Genuine Biotech's Azvudine Tablets is the first homegrown oral drug to get NMPA’s approval for COVID-19 treatment.
Aug 05, 2022
The Turkish Pharmaceutical Industry's Regulatory Landscape This article introduces the general organizational and regulatory landscape of the pharmaceutical industry in Turkey in terms of licensing, advertising and promotion, pricing & reimbursement, data privacy, and competition.
Aug 03, 2022
Key Points for Manufacturing Entrustment Under China's Marketing Authorization Holder (MAH) System China's drug marketing authorization holder (MAH) system was first piloted in China in 2015 and officially implemented in 2019. It allows MAHs to entrust manufacturing activities to other companies.
Jul 29, 2022
China's Pharmaceutical Industry Expected to Be the World's Largest in Less Than 10 Years As of 2021, China holds 12% of the global pharmaceutical market, following the United States, responsible for 40% of the total revenue worldwide. Chinese pharma market is reported to have generated 708.75 billion yuan in 2021, while Chinese domestic pharma companies amassed 502 billion USD (3.37 trillion RMB) in revenue.
Jul 28, 2022