China issues five-year plan on food and drug safety

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    Two five-year plans (2016-2020) on food and drug safety were issued by the State Council on Feb 21.

    According to the food safety plan, China will set stricter standards as well as strengthen supervision and punishment for law violators.

    The plan outlines that by 2020 sample tests should cover all kinds of food, especially pesticides and veterinary drugs.

    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.

    A comprehensive law system will be promoted based on food safety laws. Legislation on the protection of soil contamination and management of grain and fertilizer will speed up.

    Contamination of agricultural products was a focal point. The use of highly-poisonous farm chemicals and veterinary drugs will be controlled.

    The plan said that until 2020, 97 percent of agricultural products should meet quality standards.

    Punishments will be strengthened on overuse of food additives, use of industrial ingredients in food, fake production and expiration dates, and exaggerated ads for healthy food.

    Stricter supervision will be conducted on the production and sale of food, on new business models such as food e-commerce and online food-ordering, and on export and import.

    Various social sectors are welcomed to join the food supervision. Consumers, employees of food companies will be encouraged to blow the whistle. Media outlets are also encouraged to cover food safety issues.

    Drug safety

    The plan on drug safety outlines that by 2020 the quality of drugs should be further improved, the standard of medical equipment will be raised and the level of supervision will be enhanced.

    Specifically, by 2020, the plan requires the quality consistency evaluation for 289 generic drugs approved by catalog of China’s basic drugs should be completed, 3,050 national drug standards and 500 medical equipment standards revised, the updated rate of periodic drug safety report will reach 100 percent and the license holding rate for pharmaceutical practitioners will be over 0.04 percent.

    The guideline also stated that in order to achieve these goals, the quality consistency evaluation for generic drugs should be promoted, reform of the approval procedures for medical treatment should be deepened, an improved regulation system for drug standards should be set up and supervision for drug production should be strengthened.

    It also urged efforts from pharmaceutical enterprises to adopt the correct evaluation methods while carrying out more R & D and analysis during the process of quality consistency evaluation.

    According to the guideline, the marketing authorization holder (MAH) will be fully implemented in new medicines to encourage their R & D. Related industries and departments should improve medicine approval and prioritize those for rare and major disease with improved drug approval standards. Meanwhile, the reform for medical equipment management by categories will be further promoted and a risk analysis system will also be established.

    To better enhance the regulation of drug standards, the government will step up efforts on the revision of pharmaceutical administration law, strengthening the supervision of cosmetic products, medical equipment and drugs. Chemical and biological standards should remain close to global standards, with traditional Chinese medicine growing globally.

    More efforts should be made to enhance supervision on R & D, medicine production, market supply and drug usage. Related industries and enterprises should send quality analysis reports of new drugs to the China Food and Drug Administration (CFDA) before the end of each January.

    In addition, the pharmaceutical industry should establish an approval system online and further strengthen the national, provincial and city level drug testing system with a focus on major laboratory and coastal testing centers, especially biological products such as vaccines.

    Enhanced law enforcement is called for to crack down on drug related issues and emergency management should also be strengthened to handle breakout events.

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