China

According to China’s FDA (CFDA), the State Council issued two five-year plans on food and drug safety last week. In regards to food safety, violation laws and quality standards will be much stricter, with over 300 national standards for consumer foods, agricultural products and pesticides to be issued between now and 2020 in the hopes that China’s standards will meet international standards. The government plans to quicken the implementation of protection from soil contamination, and grain and fertilizer management legislation, as well as ensuring that sample tests cover all types of food, specifically with testing for pesticides and veterinary drugs. According to the plan, 97% of agricultural products are required to meet quality standards by 2020. Overusing food additives, incorporating industrial ingredients in consumer foods, falsifying expiration dates and undertaking misleading advertising for healthy foods will be punished more severely. In addition, the supervision of food production, new business models (i.e., food e-commerce and online ordering), and export and import laws will be increased.

The plan on drug safety states that pharmaceutical drug quality is to be improved, calling for the approval of 289 generic drugs, as well as the reform of 3,050 national drug standards and 500 medical equipment standards by 2020. This will ensure that the new rate of periodic drug safety reports will reach 100%. To achieve this target, the Council urges that quality evaluations for generic drugs should be endorsed, drug manufacturing and production should be better supervised, medical treatment approvals should be re-examined and drug standards regulations should be improved. To ensure better quality evaluation of drugs, the plan states that manufacturers should engage in more R&D and analysis, as well as improve supervision of market supply and usage. Businesses will be asked to send quality evaluation reports of new drugs to the CFDA before the end of January of each year. The plan also encourages the pharmaceutical industry to develop an online approval system to strengthen the local and national drug quality evaluation system, focusing on lab and coastal testing centers, and biological products. Stricter punishments will also be implemented for pharmaceutical-related incidents.

Source: The State Council, The People’s Republic of China

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