CFDA

CFDA: The Face of Regulation in China

CFDAThe China Food and Drug Administration (CFDA) was founded in 2013. Grown from the organization formally known as the State Food and Drug Administration (SFDA), the CFDA was created to combine multiple regulatory authorities into a singular regulation process for food and drug safety.

Similar to the US Food and Drug Administration (FDA), the CFDA is responsible to draft policies, laws, and regulations. Furthermore, they create regulatory guides for the pharmaceutical industry, medical devices, food safety, cosmetics, etc.

CFDA Responsibilities

In addition to the drafting and forming of industry regulations, the CFDA organizes the formation of publications, standards of practice and classification systems. Similarly, the implementation of these standards and regulations are implemented and enforced. The CFDA is also responsible for such things as:

  • Establishing emergency response systems for the food and drug industry
  • Promoting a credibility system in the global food and drug industry and cooperating with similar regulatory bodies
  • Guide local governments in respect to food and drug safety, regulations, and implementation
  • Developing technology necessary for testing systems, supervision, and tracking

Preparing for the Future

In February of this year, two five-year plans on food and drug safety were issued. The plan aims to set stricter guidelines and standards, while improving supervision and strengthening penalties for violators. According to the CFDA,

Over 300 national standards are planned to be set during the next five years. The standards will cover all consumer foods, agricultural products and pesticides. Domestic standards will be pushed to catch up with international levels of quality. Also, all standards will be open to the public online“.

There will be increased supervision for food production, and increased punishment for violators in regards to food additives, production practices, health claims, etc. The CFDA also aims to tackle to new emerging e-commerce models of food distribution. Consumers, employees and media outlets are all encouraged to report any food safety issues.

Drug safety is a top priority of the CFDA, as they plan to look at many issues and continue to improve drug and device quality in China:

…by 2020, the plan requires the quality consistency evaluation for 289 generic drugs approved by catalogue of China’s basic drugs should be completed, 3,050 national drug standards and 500 medical equipment standards revised…

Consequently, in the coming years there will be an even greater emphasis put on standards for drug regulations, approvals, and research and development strategies.

Translation Opportunities

Given the number of changes surrounding clinical trial regulations, some speculate that we will see an increase in translation needs. Previously, US and European medical device companies had been able to avoid clinical trials for some Class III devices. Moving forward, it is believed that there will be tighter restrictions on those device requirements. With the amount of documentation required for clinical trials, should they need to be repeated, it could mean that more trial material and documentation will need to be translated.

Contact us today to learn more about how CSOFT can help you navigate the CFDA standards.