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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
INDUSTRY
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
INDUSTRY
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
INDUSTRY
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
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
POLICY
Priority Review and Approval Generic Drugs
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
INDUSTRY
Priority Review and Approval Medical Insurance
In Light of the 14th Rare Disease Day, How Is China Doing on Rare Disease Drugs? On February 28, 2021, the international community observes the 14th Rare Disease Day, which is a time of the year to raise awareness among the general public and to also reflect upon the progress of orphan drugs development.
Mar 08, 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
POLICY
Priority Review and Approval Generic Drugs
China Releases Draft List of Second Batch of Encouraged Generic Medicines On Dec. 30, 2020, China National Health Commission issued the Draft List of Second Batch of 19 Generic Medicines, encouraging pharmaceutical firms to develop and produce them. Medicines for chronic obstructive pulmonary disease and asthma are included in the list.
Dec 31, 2020
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