CFDA

Subscribe to CFDA

By：Chen Bing, Dai Enchao, Gui Siyu

It has been years but many people might still recall the melamine scandal. As part of the efforts to rebuild the food safety system, infant formula registration was firstly introduced in the Food Safety Law (2015). This registration mechanism aims to enhance the safety of the formula industry by setting higher thresholds for infant formula manufacturers, and kicking out those lack sufficient capabilities in safety control and technologies.
Continue Reading Era of Infant Formula Registration- Situation, Pitfalls and Solutions

By Chen Bing  and Yang Yue King & Wood Mallesons’ Corporate & Securities group

Since the melamine milk scandal in 2008, there has been constant reform to the supervision of the infant formula industry. Registration of infant formula milk powder (“Infant Formula”) is probably one of the most significant changes. It will greatly affect all the industry players.

From 1 January 2018, the Infant Formula registration requirements in the new Food Safety Law came fully into force. Infant Formula products, either domestically manufactured or imported through general trade, must obtain formula registration before they can be sold in the PRC. This requirement will impact thousands of Infant Formula brands in the market – a great portion of which will not survive this change. 
Continue Reading New Era for Infant Formula in China

By Huang Jianwen King & Wood Mallesons’ Commercial & Regulatory group

On October 10 2017, the China Food and Drug Administration (“CFDA”) issued the Decisions Concerning the Adjustment of Imported Drug Registration (No. 35 Order by CFDA, “Decisions”). This implements the policy of encouraging new drug marketing following the earlier issuances of Opinions on Deepening the Reform of Evaluation and Approval System and Encouraging the Innovation of Drugs and Medical Devices by the General Office of the CPC Central Committee and the General Office of the State Council on October 8. 
Continue Reading The reform of imported drugs registration encourages the marketing of new drugs in China

By Mark Schaub and Chen Bing King & Wood Mallesons’ Corporate & Securities group

schaub_m1On April 28, 2017, China Food and Drug Administration (“CFDA”) released for public comment a draft Opinion on the Further Strengthening of the Supervision of Health Food (“Draft Opinion”).

The Draft Opinion leans heavily on principles already set out in the new Food Safety Law and the Administration Measures on Registration and Filing of Health Food (“Administration Measures”) of 26 February 2016 but also does give a hint as to their current thinking in relation to health food registration and filing:
Continue Reading CFDA Further Strengthen the Supervision of Health Food

This article was written by Mark Schaub and Chen Bing, King & Wood Mallesons’ Corporate Securities Group

Ischaub_mn1ternational supplement companies selling to China via the cross border ecommerce model have recently experienced a few nail biting months. Although a last minute reprieve on sales of non-registered products was granted it should be noted that registration or filing will be required at some stage in the future.

Crucially the China Food and Drug Administration (“CFDA”) is seeking public comment on several lists of health food raw materials and auxiliary materials. These lists will have a direct impact on filing and registration of products by international supplement companies in China.Continue Reading CFDA Seeks Public Comment on Permitted Ingredients List for Supplements

By Huang Jianwen  King & Wood Mallesons’ Investment Group

huang_jianwenThe Regulations on the Supervision and Administration of Cosmetics (Draft for Review) (the “Draft for Review”) drafted by China Food and Drug Administration (the “CFDA”) was published on 20 July 2015 for public comments. The current regulation governing the supervision and administration of cosmetics in China is referred to as the Regulations Concerning the Supervision of the Hygiene of Cosmetics (the “Current Regulation”). The Draft for Review contains 7 chapters, 79 articles and approximately 13,000 characters compared to the Current Regulation’s 6 chapters, 35 articles and approximately 3,000 characters.

The Current Regulation was promulgated in 1989, and became effective in 1990. It focuses on implementing a supervisory system of government reviews and approvals rather than a purely market-based approach to regulation. The Current Regulation’s supervisory measures may be relatively deficient with respect to striking down regulatory violations.
Continue Reading Highlights of the draft cosmetics supervision regulations