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You are here: Home » Gov't & Regulatory

Gov't & Regulatory

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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

  US FDA Requests $4.7 Million for China Drug Maker Inspections
Apr 11, 2013
In President Obama’s new 2014 budget request, the FDA asked for $4.7 million to carry out inspections of China pharmas that export products to the US during the fiscal year 2014. The request includes funding for nine full-time equivalent employees. In previous years, the agency did not break out separate line items for China drug safety inspections. Once the employees are trained and up to speed, the FDA projects they will conduct 120 inspections per year by 2016. More details....

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  China’s New Essential Drug List: Quality + Price
Apr 7, 2013
Last week, China issued its new 2012 Essential Drug List, a list that will have a profound effect on the pharmaceutical scene in China. Original research by ChinaBio® discovered a revolutionary change in the new rules: China’s Ministry of Health told provincial/municipal governments to consider quality – not just price – when choosing a drug supplier for the list. Under the new guidelines, provincial and local governments must provide their citizens with high quality drugs at a reasonable price. For drug companies, the change means that having one of their drugs included on the list can be a positive event, rather than a negative one. More details....

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  New Bird Flu Strain Surfaces in China; Two Dead
Apr 2, 2013
A strain of bird flu, H7N9, which has never before been diagnosed in humans, has infected seven people in China. So far, two have died. The victims did not have contact with each other, and there is no discernible pattern that would explain how these particular people have caught the disease. H7N9 is thought to be a less virulent strain than the H5N1 virus that has caused 300 deaths since its initial 2003 outbreak. More details....

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  China's MOH Issues New Essential Drug List with 520 Products
Mar 27, 2013
China’s Ministry of Health has issued its new essential medicine list, which includes 520 products, up from 307 in the 2009 version of the EDL. The 520 drugs are comprised of 317 chemical/biological drugs and 203 TCM products. Almost 200 of the products are aimed at children, redressing a deficiency of the previous EDL. Notably, the new list now includes drugs for cancer and diabetes, and some of the products come from multinational pharmas. More details....

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  SFDA to Monitor Food Safety; Will Remain Part of MOH
Mar 12, 2013
China has given the State Food and Drug Administration responsibility for monitoring the safety of the nation’s food supply. However, the Ministry of Health will continue to formulate food safety policies, which the SFDA will administer. The SFDA will remain an agency of the Ministry of Health, even though reports surfaced last week that the SFDA would become a cabinet-level department by itself, a move that would have given the agency greater stature. More details....

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  China to Give SFDA Responsibility for Food as well as Drugs
Mar 4, 2013
In the next few days, China may give the SFDA power to regulate the nation’s food supply. Presently, the SFDA has power over drugs, medical devices, cosmetics and health foods. China has suffered through several confidence-shattering food safety scandals in recent years, ranging from gutter oil to tainted milk. The reorganization will put responsibility for food safety in one ministry, rather than the confusing system currently in place that spreads jurisdiction into thirteen different agencies. In addition, the new organization will report directly to the State Council. In 2008, the SFDA was made part of the Ministry of Health. More details....

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  SFDA Proposes Further Reforms in China's Drug Approval Process
Mar 1, 2013
With the goal of encouraging innovation in both new drugs and generics, the SFDA has released new proposed guidelines for its drug review process. The most significant change will be a new emphasis on the clinical need for the drug. Drugs that address an unmet need – whether new or generic – will be given greater priority. In addition, the SFDA proposes greater emphasis on drugs for children and better protection for clinical trial participants. The SFDA aims to speed up approval for the products that address the most critical needs. More details....

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  China’s SFDA Wants to Cut Number of Drug Distribution Companies by 10,000
Feb 20, 2013
China’s SFDA has announced a set of newly-revised regulations for the country’s drug distributors. These new Good Supply Practices (GSP) for drugs, which comprise 187 articles, will promote higher standards of protection for the country’s drug supply among wholesalers and retailers. An SFDA spokesperson also said the government wants to reduce the number of China’s drug wholesalers from a current 13,000 to just 3,000, a draconian rollup of the country’s highly fragmented distribution system. More details....

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  China's State Council Issues Bio-Industry Development Plan
Feb 1, 2013
In early January, the State Council of China issued a Bio-industry Development Plan, which covers seven major bio-industries, one of which is biopharma. A major goal of the plan is to transform the entire bio-industry into a pillar industry of China’s national economy by 2020. Over the shorter term, from 2013 to 2015, the average annual growth rate for bio-industry will maintain its better-than-20% annual increase. More details....

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  China Proposes Fast-Track Approvals for Innovative Drugs
Jan 18, 2013
China’s SFDA is considering far-reaching changes to its drug approval process. The proposals would replace the present system, which considers requests on a first-come, first-serve basis, with a system that prioritizes need. Innovative drug candidates, especially those that address unmet diseases, would be processed under new fast-track procedures. On the other hand, requests for approval of generic drugs that have multiple suppliers would be discouraged. In other words, the SFDA would respond much like the market itself, rather than treating each drugmaker request as equally important. More details....

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