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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.

Marketing Approval Priority Review and Approval Innovative Drugs Generic Drugs Drug Registration New Drugs

Monthly Report: New Drug Approvals in China | Aug. 2021 In Aug. 2021, China NMPA nodded for nine new drug products including Tislelizumab Injection, Apremilast Tablet and Nivolumab Injection.

Sep 14, 2021

Marketing Approval Drug Registration

Monthly Report: New Drug Approvals in China | July 2021 In July 2021, China NMPA granted 14 new drug approvals for ten imported products and four domestic ones.

Aug 16, 2021

Laws & Regulations Marketing Approval Innovative Drugs Generic Drugs

China Rolls Out Measures to Establish Drug Patent Linkage System China tries to balance the patent protection of innovative drugs and the development of generics. MAHs of innovative drugs can bring a lawsuit or apply for an administrative ruling to protect patents. The first generics that successfully challenge the registered innovative drugs can enjoy 12-month marketing exclusivity.

Jul 23, 2021

Marketing Approval Innovative Drugs Generic Drugs New Drugs

Monthly Report: New Drug Approvals in China | June 2021 In June 2021, China NMPA granted 21 new drug approvals.

Jul 14, 2021

Marketing Approval Priority Review and Approval Drug Registration New Drugs

Monthly Report: New Drug Approvals in China | May 2021 In May 2021, China NMPA granted approvals to a total of nine innovative new drugs, improved new drugs, imported original drugs and first generics.

Jun 15, 2021

Marketing Approval Priority Review and Approval Drug Registration New Drugs

Monthly Report: New Drug Approvals in China | April 2021 In Apr. 2021, China NMPA approved a total of 12 new drugs. Eight of them are therapeutic biological products and the other four are chemical drugs.

May 14, 2021

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

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

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

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

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