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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Laws & Regulations Pharmacopeia MAH Pharmacovigilance Marketing Approval Priority Review and Approval Volume-Based Procurement
Top 10 BaiPharm Stories of China's Pharmaceutical Regulations | 2021 Recep ChemLinked BaiPharm Portal has been delivering and decoding China's pharmaceutical regulations to help international drug makers access the Chinese market. Here are the 10 regulatory topics that our readers are most concerned about in 2021.
Jan 07, 2022
REGULATION
Laws & Regulations Reference Listed Drug (RLD) MAH Marketing Approval Volume-Based Procurement
Monthly Recap: China Pharmaceutical Regulatory Updates | Nov. 2021 1. China Insulin VBP Tender Result; 2. NMPA Launches Drug Supply Information Submission System; 3. NMPAs Requires Documentation for Import/Export Permit of Analgesics and Antipsychotics; 4. NMPA Announces One Rx-to-OTC Switch; 5. The 48th Batch of Reference Listed Drugs; 6. NMPA Approves 110 Medical Devices; 7. NHC Releases Administrative Measures for National Essential Medicine List (Revised Draft); 8. NMPA Releases Administrative Measures for Quality Supervision in Drug Supply, Distribution and Use (Consultation Draft)...
Dec 16, 2021
POLICY
Volume-Based Procurement Biological Products
China's Insulin VBP Saw Average Price Cut of 48.75% China’s insulin VBP (volume-based procurement)--eleven drug makers won the bid to supply insulin products to public healthcare institutions across China. Among 42 bid-winner products, Novo Nordisk took the champion with seven products. Two local Chinese companies—Gan & Lee and the United Laboratories—took the second and third places with six products respectively.
Dec 06, 2021
POLICY
Volume-Based Procurement
A Record Number of Foreign Companies Win Bidding for China's 5th VBP of Drugs 251 products from 148 companies won the bidding on June 23 in Shanghai for the latest and fifth round of China’s national centralized drug procurement. The bidding saw some record numbers. One of them is the unprecedented number of 10 international pharma companies successfully earning places in the procurement program.
Jun 30, 2021
POLICY
Volume-Based Procurement
Data Analysis: What "4+7" Procurement Has Brought to China Drug Market The “4+7” procurement program opens a gate to a larger market for some drug products. But larger sales volume does not necessarily mean higher sales revenue.
May 31, 2021
POLICY
NRDL Volume-Based Procurement Medical Insurance
China Promotes Distribution of Medicare-covered Drugs Through "Double 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
Laws & Regulations Volume-Based Procurement Medical 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
POLICY
Volume-Based Procurement Diabetes
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
POLICY
NRDL Volume-Based Procurement Medical Insurance Cancer Rare Disease
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.
Mar 08, 2021
POLICY
Volume-Based Procurement Diabetes
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.
Mar 08, 2021
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