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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation CDE Guideline Marketing Approval Priority Review and Approval NRDL Health Insurance Rare Disease Drug Registration Real World Data
The 16th Rare Disease Day: China's Efforts to Make Orphan Drugs Available and Affordable This year’s Feb. 28 marks the 16th International Rare Disease Day. In China, there are around 20 million rare disease patients, with more than 200,000 additional patients each year. China has shown a supportive attitude towards rare disease drug development in a series of official documents. The regulations and policies introduced in this article are significant in terms of the drugs’ marketing authorization review timeline and pricing.
Mar 10, 2023
POLICY
NRDL Health Insurance New Drug COVID-19
[Updated] China Adds 111 Drugs to 2022 National Reimbursement Drug List (NRDL) On Mar. 1, 2023, China starts to implement the 2022 National Reimbursement Drug List (NRDL), a list of drugs fully or partially reimbursed by the national basic health insurance.
Mar 01, 2023
REGULATION
Law & Regulation CDE Guideline Pharmacopoeia Reference Listed Drug (RLD) GMP Clinical Trial NRDL Health Insurance Generic Drug OTC Drug Cancer
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2022 Find out the latest pharmaceutical regulatory updates in China: 1. China SAMR to Permit Online Sales of Prescription Drugs Nationwide; 2. China NMPA Grants One Rx-to-OTC Switch; 3. China NMPA Releases 183 RLDs; 4. China CFDI Consults on Inspection Guidance for Blood Products; 5. China NHSA Announces 343 Drugs Passing the Format Review for NRDL; 6. China CDE Releases Pharmaceutical Guidelines; 7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards and Guideline
Oct 03, 2022
REGULATION
Law & Regulation MAH Pharmacovigilance Marketing Approval Priority Review and Approval Health Insurance Innovative Drug Generic Drug Rare Disease Drug Registration New Drug
China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law Find out the highlights in revised draft of the Regulations for Implementation of the Drug Administration Law: pharmaceutical innovation, acceptance of foreign clinical data, support the development of pediatric and rare disease drugs...
May 13, 2022
POLICY
Law & Regulation Marketing Approval Volume-based Procurement Health Insurance Innovative Drug Cancer Cardiovascular Disease Rare Disease Drug Registration New Drug
China's 2022 Two Sessions: Goals and Proposals for Pharma & Healthcare Industry China's Government Work Report says one off the major tasks for 2022 is to improve medical and health services.
Mar 15, 2022
INDUSTRY
NRDL Health Insurance
Best-selling Ophthalmic Drugs in China | Market Wrap 2021 The year 2021 has seen a remarkable growth of the ophthalmic drug market in China. The market size of chemical drugs for eye diseases is estimated to exceed 3.5 billion yuan (circa 549 million USD), with a year-on-year growth of 1.89%.
Jan 10, 2022
POLICY
NRDL Health Insurance Innovative Drug Cancer Rare Disease
China Adds 74 Drugs to National Reimbursement Drug List (NRDL) On Dec. 3, China released its 2021 National Reimbursement Drug List (NRDL). NRDL is a list of drugs allowable for reimbursement by the national social health insurance fund under the social security system which has covered more than 1.36 billion people in China by the end of 2020.
Dec 08, 2021
POLICY
NRDL Health Insurance
China Promotes Distribution of Medicare-covered Drugs Through Dual Channel China permits qualified drug stores to sell prescription drugs included in the National Reimbursement Drug List. At these drug stores, people can enjoy the same medical care payment coverage with hospitals. The policy intends to add another sales channel for the drugs outside hospitals, especially for the newly listed drugs through centralized procurement.
May 24, 2021
POLICY
Law & Regulation Volume-based Procurement Health Insurance
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
INDUSTRY
Priority Review and Approval Health 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
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