Policy / Regulatory

In a joint effort to streamline access to critical medical resources, the Beijing Municipal Medical Products Administration (BJMPA), the Beijing Municipal Health Commission (BJHC), the Beijing Municipal Medical Insurance bureau, and Beijing Customs have introduced the “Implementation Plan for Promoting the Temporary Import of Clinically Urgently Needed Drugs and Devices…

Authorities in Beijing, including the Beijing Municipal Bureau of Commerce and the Beijing Municipal Service and Data Administration, have issued the ‘Management Measures for Negative List of Data Export from China (Beijing) Pilot Free Trade Zone (Trial)’ and the ‘Management List of Data Export from China (Beijing) Pilot Free Trade…

The National Medical Products Administration (NMPA) has disclosed plans to expand the scope of its volume-based procurement (VBP) tendering to include high-value medical consumables such as cochlear implants during an inspection visit to the Medical Purchasing Center and associated medical institutions in Tianjin. The administration intends to tailor the procurement…

On September 5, 2024, the Guangzhou Health Commission issued the “Guangzhou Health Commission’s Ten Measures to Support the High-Quality Development of Innovative Pharmaceuticals and Medical Devices,” aiming to foster the growth of innovative pharmaceuticals and medical devices. The measures encourage private capital to participate in the construction of research hospitals…

Lei Haichao, Director of China’s National Health Commission (NHC), has outlined a comprehensive reform agenda for the country’s medical and health system in an article on qstheory.cn, a key party news platform. The reform blueprint emphasizes a triad approach, focusing on the harmonized development and governance of healthcare services, medical…

BEIJING—As of September 1, 2024, a total of 19 provinces, municipalities, and the Xinjiang Production and Construction Corps (Bingtuan) have incorporated assisted reproductive technology (ART) into their medical insurance reimbursement schemes. This move marks a significant expansion in healthcare coverage, with regions such as Beijing, Guangxi, Inner Mongolia, Gansu, and…

JIANGXI—In a strategic move to enhance drug accessibility, the Healthcare Security Administration (HSA) bureau of Jiangxi province has initiated a province-wide campaign known as the “Three Entries,” aiming to make centrally procured drugs available in retail pharmacies, private medical institutions, and village clinics, including community health service centers and stations.…

BEIJING—The National Drug Alliance Procurement Office, which oversees the Volume-Based Procurement (VBP) program, has announced that six pharmaceutical firms have been identified to have colluded during the bidding and negotiation process for bromhexine in the 7th national VBP tender. Among the accused are Chengdu Xinjie Hi-tech Development Co., Ltd, Renhe…

Reports from BioCentury and Endpoints News, based on anonymous insider sources, suggest that US lawmakers are currently gathering information on clinical trials conducted at hospitals with ties to the Chinese military as part of the Biosecure Act. The House Select Committee on the Chinese Communist Party and other congressional offices…

The Shanghai municipal government has issued a comprehensive set of measures aimed at bolstering the region’s biopharmaceutical industry. The finalized policies, following a public consultation period in June 2021, are set to take effect from August 1, 2024, through July 31, 2029. The measures cover a wide range of areas,…

The National Medical Products Administration (NMPA) of China has released the “Guidelines for Onsite Inspection of Medical Device Operation Quality Management Standards,” which detail the process for on-site verification of business licenses for medical device operating enterprises, including any changes or extensions. According to the guidelines, if an enterprise’s applicable…

The National Medical Products Administration (NMPA) in China has taken a decisive step to suspend the import, distribution, and utilization of cefodizime, an antibiotic from Daewoong Bio Inc., a South Korean pharmaceutical company. This move comes after Daewoong declined to cooperate with the NMPA’s scheduled on-site inspections, citing non-compliance with…

The National Medical Products Administration (NMPA) has issued a notice to suspend the import, sale, and use of the Trekking knee system and components of hip prosthesis manufactured by Italy-based firm SAMO S.p.A. This decision comes after remote non-onsite inspections revealed several compliance issues. The company was found to have…

The National Medical Products Administration (NMPA) and the National Health Commission have issued the Management Requirements for Temporary Import and Use of Clinically Urgent Medical Devices in Medical Institutions, which are set to take effect immediately. This new regulation is designed to address the urgent clinical needs of patients by…

US House of Representatives Speaker Mike Johnson has suggested that a vote on the Biosecure Act could be on the cards before the year’s end. Speaking at a summit organized by the right-wing think-tank The Hudson Institute, Johnson discussed potential immediate measures to counteract “the threat” from China ahead of…

The National Medical Products Administration (NMPA) has released a draft proposal titled “Announcement of the National Medical Products Administration on Further Optimizing the Review and Approval of Clinically Urgently Needed Overseas Marketed Drugs,” and is soliciting public feedback until July 24. The draft proposal indicates that clinically urgently needed overseas…

The Gansu Medical Products Administration has issued a set of “Measures for the Management of Key Quality and Safety Personnel within Production and Operation Enterprises in Gansu Province (Trial)”. The notice is designed to regulate the key management personnel of drug production and distribution enterprises within the province. According to…

The Guangdong Pharmaceutical Association (GDPA) has released the Off-label Drug Use Catalogue for the year 2024, which includes 44 additional off-label uses, with half of these being based on approved indications in the United States. As an academic, non-profit social organization, GDPA has been a pioneer in establishing off-label drug…

The provincial governments of Jiangxi, Shanghai, Qinghai, and Zhejiang have added assisted reproductive technology (ART) to their medical insurance payment systems, effective from June 1, 2024. This move follows the lead of Beijing, Guangxi, Gansu, Inner Mongolia, and Shandong, which have been covering ART under medical insurance since July 1,…

The Healthcare Security Administration (HSA) bureau in Guangzhou’s province has issued a notification outlining measures to support the development of innovative drugs within the city. The initiative aims to stimulate biopharmaceutical companies’ innovative development by ensuring improved access to novel drugs and devices in clinical settings.

The National Medical Products Administration (NMPA) and the National Health Commission (NHC) of China have issued a notification to enhance the management and control of certain substances, effective from July 1, 2024. Dextromethorphan, lorcaserin, and diphenoxylate will be reclassified under the Category II psychotropic drug list, while midazolam will be…

The National Medical Products Administration (NMPA) has revised the “Notice on Standardizing the Classification of Medical Device Products,” initially issued by the China Food and Drug Administration in 2017. The updated document, which will be effective from September 1, 2024, aims to enhance the classification management of medical devices, standardize…

The China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE) has released its report on China’s health product trade for the first quarter of 2024, showing a 6.3% year-on-year (YOY) increase in global pharmaceutical trade, reaching USD 46.944 billion. Imports grew by 11.21% YOY to…

The European Union (EU) is reportedly gearing up to launch an investigation into medical device procurement practices in China, as reported by Bloomberg News. The inquiry will focus on whether domestic suppliers are being unfairly favored in the procurement process. Sources indicate that the investigation could commence this month and…

The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has unanimously voted to recommend the use of minimal residual disease (MRD) as an accelerated approval endpoint in clinical trials for multiple myeloma. The 12-0 vote by the committee, which serves as a recommendation to the…

The Shanghai Municipal Health Commission has issued the “Implementation Rules for the Nine Guidelines for Clean and Honest Employment of Medical Institution Staff in Shanghai,” marking a significant step towards enhancing integrity and professionalism within the city’s medical community. The rules aim to address a range of misconduct, including commercial…

China’s Minister of Commerce, Wang Wentao, convened a high-level meeting with top executives from the global pharmaceutical industry, including leaders from Bristol-Myers Squibb, GlaxoSmithKline, Danaher, Pfizer, Abbott, Sanofi, Takeda Pharmaceuticals, Gilead, Merck, Sharp & Dohme, and more. Also in attendance was a representative from the Pharmaceutical Research and Manufacturers of…

China’s Supreme People’s Court, along with the Supreme People’s Procuratorate and the Ministry of Public Security, has issued new “Guiding Opinions Concerning Handling of Criminal Cases Related to Medical Insurance Fraud.” This initiative aims to strengthen the legal framework against fraudulent activities in the medical insurance sector. Under the new…

The National Medical Products Administration (NMPA) has released its 2023 medical device filings work report, detailing the review and approval processes over the past year. In 2023, the NMPA received 13,260 applications for initial registration, renewal registration, and change registration of medical devices, representing a 25.4% increase from 2022. The…

The Health Commission of Sichuan Province has issued a notification aimed at enhancing the management of ex-hospital allocation prescriptions at medical institutions. Ex-hospital allocation prescriptions are those written for drugs not available within the hospital’s inventory during hospitalization, outpatient, or emergency treatment, or prescribed at the request of patients. After…

Corruption investigations have been launched against former senior officials of the Healthcare Security Administration (HSA) in Guizhou and Hainan provinces, according to the respective provincial disciplinary inspection commissions. In Guizhou, Song Yufeng, Chairman of the Social Construction Committee of the Guizhou Provincial People’s Congress, is under disciplinary review for serious…

The Ministry of Commerce (MofCOM) has released its annual statistical review of China’s pharmaceutical distribution industry for 2022, indicating steady growth within the national medical distribution market. Total sales across seven major categories of medical and pharmaceutical products reached RMB 2,751.6 billion (USD 387.5 billion), reflecting a 6.0% year-on-year increase,…

Shanghai is advancing towards a significant milestone in pharmaceutical safety with plans to establish the largest adverse drug reaction (ADR) database in China. The nascent database has already amassed nearly 300,000 personal drug files and an excess of 10,000 ADR reports, providing a robust foundation for the project. The “Setting…

In a strategic move to assert the value and historical significance of Traditional Chinese Medicine (TCM), China’s Ministry of Health, in conjunction with 15 other government departments, has issued the “Traditional Chinese Medicine Innovation & Development Guidelines from 2006 to 2020” in March. These comprehensive guidelines are seen as a…

China’s State Food and Drug Administration (SFDA) is poised to embrace a new era of transparency with the announcement of its forthcoming measures by Shao Mingli, the agency’s head. Scheduled for the second half of 2007, the SFDA is preparing to initiate regular press conferences, a proactive step designed to…

Since 2007, Guangdong province’s medical facilities have utilized an online procurement system known as “Sunlight Purchase” for drug acquisitions. However, this system has inadvertently ignited an unprecedented pricing war, simultaneously exposing deep-rooted issues within drug pricing structures. A pivotal conference convened on March 31 by the Guangdong Drug Purchase Service…