Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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
China Releases Guidance for Declaration of Chemical Drug Changes On Feb. 10, 2021, China Center for Drug Evaluation issued and started implementing the Guidance for Acceptance and Review of Chemical Drug Changes (Trial). The document addresses supplemental applications that entail the reviews of state-level drug regulatory authorities, including those submitted during clinical trials.
Mar 19, 2021
China's 2021 Two Sessions: What Can We Expect for the Medical and Health Sectors? Chinese Premier Li Keqiang pointed out nine major objectives in the medical and health sectors in 2021 in the Government Work Report on March 5th.
Mar 15, 2021
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
China to Carry out National Insulin Procurement China will pilot a nationwide insulin procurement which may refer to the previous pilot insulin procurement scheme in Wuhan. It means the price of insulin products will be significantly reduced, and the market share of relevant pharmaceutical companies in China will be affected.
Mar 08, 2021
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
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
Chinese Market Becomes More Intense for Antidiabetic Drugs China's fourth round of national centralized drug procurement has begun, according to the Jinfu Chen, deputy head of the National Healthcare Security Administration in Beijing on Jan. 29, 2021. This time five new diabetes medications are included in the procurement list. They are empagliflozin, canagliflozin, repaglinide, nateglinide, and gliclazide.
Jan 30, 2021
China's 2020 National Reimbursement Drug List Includes 119 Additional Drugs China's National Healthcare Security Administration and the Ministry of Human Resources and Social Security have released the 2020 Edition of the National Reimbursement Drug List (NRDL) on Dec. 28, 2020, which will take effect on Mar. 1, 2021.
Jan 17, 2021
- Monthly Recap: China Pharmaceutical Regulatory Updates | July 2021
- China Drug Evaluation Report 2020-Reform of Drug Review & Approval System
- Monthly Report: New Drug Approvals in China | Aug. 2021
- Monthly Recap: China Pharmaceutical Regulatory Updates | Aug. 2021
- China to Exempt Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials