CFDA adjusts some administrative approval procedures for drugs and medical devices – April 07, 2017
In order to optimize the evaluation and approval procedures for drugs and medical devices, and improve evaluation and approval efficiency, China Food and Drug Administration (CFDA) has issued adjustment of some Administrative Approval Procedures for Drugs, and The Decision of CFDA on Adjusting Some Administrative Approval Procedures for Medical Devices, to adjust CFDA’s administrative approval procedures for the approval of clinical trials, the approval of re-registration and registration renewal, and the approval of registration alteration of drugs and medical devices.
China issues five-year plan on food and drug safety – February 22, 2017
China is planning to outline tests to cover all kinds of food, especially pesticides and veterinary drugs by 2020.
By 2020 over 300 national standards will be set and will be very strict. 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 will have 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 will meet quality standards. 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.
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.
By 2020 quality consistency evaluation for 289 generic drugs approved by catalogue of China’s basic drugs will 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.
Medical devices Quality management systems Requirements for regulatory purposes Released – January 19, 2017
On January 19, 2017, China Food and Drug Administration (CFDA) issued YY/T0287-2017 / ISO 13485:2016 “Medical devices–Quality management systems–Requirements for regulatory purposes”, which will come into force as of May 1, 2017.
It further stresses regulation, emphasizes the importance and necessity of implementing regulatory requirements. It also improves the compatibility of regulations and the standard; defines that the quality management system standard is applicable to medical device organizations at all stages of the full life cycle of industrial chain, further it guarantees the safety and effectiveness of medical devices at all stages. It escalates the new requirements based on risk analysis and risk management. It adds new requirements on the post-market surveillance and improvement of medical devices.
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