SGS Societe Generale de Surveillance : Current Status of CFDA in China

Since the 1950's, the State Drug Administrative Department, a division under the State Health Administrative Department, was responsible for national pharmaceutical supervision and administration while the Drug Administrative Departments at the county level were entitled to supervise and administer local pharmaceutical activities in China. In 1998, the China State Council, which oversees all governmental departments, published a bulletin to create and implement a new institution directly under the State Council. The institution, named the State Drug Administration (SDA), was founded on the basis of its predecessor, the State Drug Administrative Department, and is responsible for national pharmaceutical supervision and administration. Five years later, the SDA expanded its duty scope to include food, health products and cosmetics, and was consequently renamed the State Food and Drug Administration (SFDA). However, in 2008 the SFDA once again became subordinated to the State Health Administrative Department. In March, 2013, the China State Council took the action of merging the SFDA with Food Safety Commission Office, and designating the new entity as the China Food and Drug Administration (CFDA). Although the Food Safety Commission Office still maintains its title, the SFDA acts as its executive bureau, directly under the State Council. Additionally, the duties of supervision and administration of food safety at the production and distribution levels were transferred to CFDA from the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and State Administration for Industry & Commerce (SAIC). Subsequently, the CFDA has provided unified supervision and administration of food and drug safety and effectiveness at production, distribution and consumption stages in China[1].

The most revolutionary part of CFDA is that every single stage throughout food and drug industry supply chain is legally under the government's efficient supervision and administration, from production to consumption. Despite its job functions, the CFDA has also transformed the traditional Chinese governmental working style by adopting integrated management rather than sectioned management. Previously, the supervision and administration of food and drugs were divided and distributed to multiple official authorities. For instance, the State Drug Administrative Department was responsible for drug supervision, the State Department of Agriculture, Forestry and Fishery was responsible for supervision of cultivation of agriculture and breeding industry, State Administration for Industry & Commerce was responsible for market distribution of food and drugs. While such sectioned management appeared to be a clear and well-distributed operating system, when faced with a tough issue, each department tried to shirk their responsibilities and claim the issue to be the other department's duties. On the other hand, when a beneficiary project comes along, all departments strive to get the opportunity. This is the reason why CFDA adopted an integrated management system, replacing sectioned management, in order to promote public administration and to provide a reliable guarantee of food and drug safety. Using integrated management, the CFDA consolidates administrative resources, technical support, and information resources so that it can better serve and focus on a specific supervision target. From an economic perspective, the cost of abiding by the law and the supervisees' burden are correspondingly reduced as well[2].

Additionally, the CFDA intends to strengthen the public social supervision and raise the status of consumers in the market. Consumers have now gained more participation in the formulation of food standards, the selection of risk assessment, reporting of clues to crimes, and criminal punishment. This innovative concept was considered to be the biggest revolution since it revealed that the government's responsiveness to the needs of the poeple rather than being autocratic.

The establishment of the CFDA represents that a huge revolution for the food and drug administrative system of China is taking place. Along with CFDA's appearance, more significant measures will be implemented. For instance, one such measure requires the continuous improvement of food and drug legal system. As the laws and regulations concerning food and drug improve, food and drug supervision and administration system will likewise improve, which will lead to updated laws and regulations and thus will form a virtual cycle. Hence, there is no doubt that the legislation and revision of food and drug safety laws will be one of the most important focuses in the future.

Although the CFDA unifies the supervision and administration of every stage in the food and drug industry chain, its supervision of food and drugs is not seamless. There are still plenty of legal loopholes uncovered by the CFDA, such as standard setting, administrative licensing, supervision of imports and exports, food chain source management, etc. Even worse, certain handling processes of food administrative licensing and standards setting are still under the State Health Department's jurisdiction rather than CFDA's. Regardless of all the various loopholes above, the linking of the different types of administrative activities within the CFDA itself will be one of the toughest issues it will face[3].

In addition, another potential disadvantage of the new supervision system is that unified supervision and administration, while striving to be an idealized system, may be difficult to implement in practical terms. For instance, there are many small food production companies dispersed throughout China. Considering that the sources of agricultural products are from all parts of the country and may prove hard to trace, these instances could arise with some frequency rather than special or complicated cases. Therefore, unified supervision over various food companies poses a challenge. Furthermore, many unexpected problems or embarrassing situations could pop up due to this mandatory unified administration and thus it becomes even more difficult to implement the new food and drug supervision and administration system and relevant laws.

There is an apparent focus on food because the CFDA restructuring is the government's remedial measure after several serious food safety scandals in China; the most notable being the '2008 Chinese Milk Scandal'. Since then, food safety has been supervised as strictly as drug safety. However, for drug manufacturers, the new CFDA also means stricter supervision as the CFDA strives to raise the bar and increase compliance. The ideal is to have all manufacturers achieve GMP standards.

The CFDA was established by merging multiple, relevant but dispersed duties into one official institution, under a movement known as Super-Ministry Reform. Such an official authority was established in order to increase the government's working efficiency by reducing unnecessary administrative procedures, removing repetitive duties covered by multiple institutes, decreasing over-constraint on enterprises and enhancing the enterprises' autonomy and creativity, wall of which will ultimately elevate food and drug safety standards.

How the CFDA deals with certain defective processes and potential problems as they arise in complicated, real-life scenarios during this its implementation will be a good gauge of how it is succeeding in its mission. However, it is believed that the State Council will notice these problems during practice and introduce better, practical solutions by taking China's special circumstances into consideration. While these transitions may be just the beginning, the CFDA is posed to be the foundation needed for the safe supervision of food and drug products for the new China.

At SGS, we monitor the guidances issued by the CFDA in order to stay abreast of all regulatory developments. Furthermore, our FDA-registered Shanghai laboratory operates according to cGMP and ISO 17025. With 21 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides clinical trial management (Phase I to IV) and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.

1. Zhao Chao & Huo Xiaoguang (2013), the State Council will create and implement CFDA, Xinhua Net
2. Hu Hao & Zhu Liyi (2013), If CFDA Enhance Efficiency, Xinhua Net
3. Meng Xi, Cui Xinpin & PanYu (2014), the Opportunities & Challenges Brought by CFDA, Food Industry Science & Technology 275-278.