China Life Sciences & Healthcare Update – Autumn 2019


SAMR solicits comments on biologic lot release management, 18 November 2019

The State Administration for Market Regulation ("SAMR") of the People's Republic of China ("PRC") released the Circular on Seeking Public Comments on the Administrative Measures for Lot Release of Biological Products (Revised Draft for Comment) ("Draft") on 18 November 2019. The Draft is open for public comment until 17 December 2019. It is composed of eight chapters, including general provisions, the determination of the lot release regulatory agency, application information for lot release, details on review and testing, inspections and licensing, re-examination information, disclosure information, legal liabilities and miscellaneous provisions.

Under the Draft, biologics cover vaccine products, blood products and other biological products regulated by the National Medical Products Administration (“NMPA”). Unless otherwise approved by the NMPA, no lot of any licensed biologics can be released, imported or distributed prior to the completion of lot release tests. According to the Draft, the Market Authorisation Holder (“MAH”) with the drug approval document for the relevant biological product has the obligation to file the lot release application. In order to pass the lot release tests, manufacturers must comply with national drug or drug quality standards.

To read the full text of the Draft (in Chinese only), please click here.

SAMR updates guide for naming health foods, 12 November 2019

The SAMR released the 2019 version of the Guide for Naming Health Foods (“Guide”) on 12 November 2019 in order to combat misunderstanding among consumers about health food. The Guide is made up of four sections, including information of health food names, basic principles for naming health foods, contents that health food names may not contain and the requirements for health food name applications and review.

Health foods refer to food that has specific healthcare or body-regulating functions, but cannot be used for treating diseases. The name of a health food product consists of three sub names, including a trade name, a generic name and an attribute name. The trade name refers to a registered or unregistered trade mark. The generic name refers to one that could indicate raw materials or other characteristics. The attribute name refers to dosage or categories. A name should not mislead or deceive consumers, or contain any deceptive or misleading content indicating disease prevention or treatment. A manufacturer can apply only one name to one product.

To read the full text of the Guide (in Chinese only), please click here.

CNCA amends implementation rules for organic product certification, 12 November 2019

The Certification and Accreditation Administration of China ("CNCA") released the Implementation Rules for Organic Product Certification (“Implementation Rules”) on 12 November 2019. The Implementation Rules will take effect on 1 January 2020 and are composed of ten chapters, including purposes and scope, requirements for certification institutes, requirements for certification personnel, certification standards, certification proceedings, post-certification management, re-certification, management of certificates and certification marks, information reports and certification fees.

The Implementation Rules apply to the certification, manufacturing, processing and distribution of organic products within China. In the event that the CNCA concludes organic certification with another country, the Implementation Rules will not apply. These manufacturers should comply with the national standard GB/T 19630 in order to pass certification tests. An organic certification is valid for only 12 months. If the manufacturer intends to extend the validity period, they should apply for re-certification three months before the previous certification expires.

To read the full text of the Implementation Rules (in Chinese only), please click here.

SPC solicits public comments on judicial interpretations for food safety cases, 11 November 2019

The Supreme People’s Court of China released the draft Judicial Interpretations for Trial of Food Safety Cases (“Draft Interpretations”) on 11 November 2019. They are open for public comment until 10 December 2019. The Draft Interpretations are composed of three sections, including legal persons subject to food safety, civil liabilities, identification and allocation of food safety civil liabilities and miscellaneous provisions. 

The Draft Interpretations clarify the following circumstances where a distributor is considered to have known that the relevant food does not meet national food safety standards. In that case, punitive damages may apply. These circumstances include, but are not limited to selling food beyond the expiration date as well as transferring, concealing or illegally destroying food purchase and sales records, financial books and providing false information. By national food safety standards, the Supreme People’s Court is referring to Chinese food safety standards. Defence on the grounds that the import food comply with the standards of the country of origin would not be upheld by Chinese courts. In addition, the Draft Interpretations clarify that personal injury would not be a precondition for the application of punitive damages.

To read the full text of the Draft Interpretations, please click here.

China amends Implementing Regulations of the Food Safety Law, 31 October 2019

The State Council released the amended Implementing Regulations of the Food Safety Law of the People's Republic of China (“Implementing Regulations”) on 31 October 2019. The Implementing Regulations, which will take effect on 1 December 2019, are composed of ten chapters, including general provisions, food safety risk monitoring and assessment, food safety standards, food manufacturing and distribution, food testing, food import and export, responses to food safety incidents, supervision and administration, legal liabilities and miscellaneous provisions.

Compared to the existing rules, the most significant changes in the Implementing Regulations include: non-compliance records relating to food safety will be added to the company’s credit files, which will affect the market entry, financing and other activities of the company. The Implementing Regulations state that local governments should not draft local standards on special foods such as health food. Specifically, this means that any local standards on special foods will be void and non-binding.

To read the full text of the Implementing Regulations (in Chinese only), please click here.