Gov't & Regulatory

State FDA (SFDA), Ministry of Science and Technology (MOST), Minsitry of Health (MOH) and other China government agency policies and regulations and how they impact the industry...

Recent Articles

China Allocates $5.5 billion to Implement Healthcare Reform Feb 23, 2010: China's Ministry of Finance (MoF) announced Friday that the central government had authorized the spending of 37 billion RMB ($5.5 billion) as part of its larger 850 billion RMB healthcare reform, announced last year. The new money will help give medical care access to lower-income citizens. More details...

China’s State Council Reveals Hospital Reform Plan Feb 4, 2010: China will implement its nationwide public hospital reform by establishing pilot programs that move away from the profit motive, which has been in effect for the past years. The programs will be spread across the country, with at least one located in each province, autonomous region and municipality. Unfortunately, details of the reform plan are sketchy. More details...

China Releases a New National Drug Reimbursement List Dec 2, 2009: On November 30th, China’s MoHRSS (Ministry of Human Resources and Social Security) released the 2009 version of the National Drug Reimbursement List, which includes 260 new drugs, bringing it to a total of 2151 products. In the new list, all 307 members of the Essential Drug List are automatically included in the A class, which confers the highest levels of insurance reimbursement on these basic drugs. It was the first update of the Reimbursement List since 2004. More details...

China Reveals 2009 Medical Reform Plans Jul 27, 2009: Last week, the State Council of China detailed its 2009 plans for healthcare reform. China’s national government is committed to a top-to-bottom overhaul of its medical system by 2020, and it is slowly releasing the specific, year-by-year steps it will take to achieve its overarching policy goals. As an example of the unhurried quality of its announcements, the 2009 plans were declared after more than half of the year has passed. More details...

China Unveils 11-Year Health Plan Apr 6, 2009: China has officially unveiled its health plan goals for the next eleven years, ending in 2020, a reform aimed at bringing basic healthcare to all of its 1.3 billion citizens and building up the nation’s public health system. The Central Committee of the Communist Party of China and the State Council endorsed a broad, ambitious objective: By 2020, China will have a basic health-care system that can provide safe, effective, convenient and affordable health services to urban and rural residents. More details...

Waves of Changes in Chinese Patent Law and Regulations: Final Update -- Part II Jan 26, 2009: China's patent statutes and administrative rules have just completed their third major revision since they were first instituted in 1984. The most recent revision has been underway for almost four years and involved three separate draft proposals. Here, Dr. Charles Liu of Unitalen Law discusses the patent law changes and the process involved to arrive at the final version. In this second of three installments, Dr. Liu covers the topics Design Patents, Limited Exceptions from Infringement, and Damages and Injunctive Relief, and Patent Counterfeiting. More details…

China Will Spend $123 Billion on Healthcare Reform Jan 23, 2009: China announced that it will spend 850 billion RMB ($123 billion) to implement the first three-year phase of its comprehensive healthcare reform plan. Chief among the plan’s goals are to extend medical insurance to 90% of China’s 1.3 billion inhabitants by 2011, which is the end of the three-year initial phase. Other aims are to initiate a system of "basic medicines" covered by the insurance, an improved network of local-level clinics, a better public health system and improved services in public hospitals. More details...

Waves of Changes in Chinese Patent Law and Regulations: Final Update, Part I Jan 19, 2009: China's patent statutes and administrative rules have just completed their third major revision since they were first instituted in 1984. The most recent revision has been underway for almost four years and involved three separate draft proposals. Here, Dr. Charles Liu of Unitalen Law discusses the patent law changes and the process involved to arrive at the final version. We will present the material in three installments, starting with the topics Novelty and Inventiveness, Secrecy Check and Foreign Filing License, and Crossover of Invention and Utility Model. More details...

China Will Experiment with Zero Markup on Drugs in Hospitals Jan 16, 2009: As part of its upcoming reform of healthcare policy, China is expected to implement a trial policy of zero markup on drugs distributed from government hospitals and health centers. The government will establish pilot programs in several cities that will wipe out the 7% to 15% markup on certain drugs that is currently allowed by the central government. The initiative was announced in an address delivered to the 2009 National Health Working Conference by Chen Zhu, the Minister of the Ministry of Health. More details...

Final China Medical Reform Plan Expected In January Dec 30, 2008: In January, China is expected to issue its official medical reform plan, under which the country will provide universal medical service by 2020 to its 1.3 billion people, including the currently underserved rural population. The plan states as a central provision that it is the government’s responsibility to play the dominate role in providing public health and basic medical service. That principal reverses a trend toward privatizing healthcare in China and putting the responsibility on the individual. Both the central and local governments will increase their levels of financial support. The final version of the plan is expected to be very similar to the draft, which was made available on October 14 on the website of the National Development and Reform Commission (NDRC). More details...