Contributor: Amanda Mao, PhD; Jing Yu
Last updated: 3 Feb 2021
In China, the State Administration for Market Regulation (SAMR) is responsible for overseeing the vetting of advertisements for drugs, medical devices, health food and food for special medical purposes. Provincial-level SAMR bureaus vet these advertisements within their respective administrative areas.
Recently, the Interim Measures for the Examination and Administration of Advertisements for Drugs, Medical Devices, Health Food and Food for Special Medical Purposes (link in Chinese) were issued and have taken effect since 1 March 2020. The Interim Measures have detailed rules on advertising these products.
An advertisement for drugs, medical devices, health food and food for special medical purposes shall display its approval number on a prominent place. No advertisement on any drug, medical device, health food or food for special medical purposes shall be released without being vetted.
The validity period of an advertisement is the same as the shortest validity period of a product registration certificate, notification certificate or production permit. If the certificate or permit does not specify a validity period, it will be two years for an approved advertisement.
When only a product name (including a drug’s generic name and trading name) is advertised for drugs, medical devices, health food and food for special medical purposes, the content is exempt from being vetted.
Drugs
The content of a drug advertisement shall comply with the product package insert approved by the drug administration agency of the State Council. When a drug advertisement involves a drug name, indication, function or pharmacology, it shall fall within the scope of the product label.
A drug advertisement shall clearly indicate contraindications and adverse reactions. Besides, advertisements for prescription drugs shall clearly state that “This advertisement is for medical and pharmaceutical professionals only”. Advertisements for Over-The-Counter drugs shall clearly display the OTC mark, and state “Please purchase and use the drug according to the package insert or under the guidance of a pharmacist”.
Medical Devices
The content of a medical device advertisement shall comply with the registration certificate, notification certificate or package insert approved via registration or notification from the drug administration agency.
Where an advertisement involves a name, scope of application, mechanism of action, structure or composition of a medical device, it shall fall within the scope of the registration certificate, notification certificate or package insert approved via registration or notification.
Advertisements for medical devices recommended for personal use shall clearly state that “Please read the product instruction carefully. Purchase and use under the guidance of a medical professional”. When a registration certificate contains contraindications and precautions, the advertisement shall clearly state “See the instruction for contraindications and precautions”.
Health Food
The content of an advertisement for health food shall comply with the registration certificate, notification certificate, or package insert approved via registration or notification from the market administration agency. The advertisement shall not suggest disease prevention or treatment. When an advertisement involves health care functions, functional ingredients, characteristic ingredients and content, suitable population and dosage, it shall fall within the scope of the registration certificate, notification certificate or package insert approved via registration or notification.
A health food advertisement shall clearly state that “Health food is not a drug and cannot replace drugs to treat diseases”. It shall also clearly display the health food mark, and suitable and unsuitable population.
Food for Special Medical Purposes
The content of an advertisement for food for special medical purposes shall comply with the registration certificate, product label or package insert approved by the SAMR. When an advertisement involves product name, formula, nutrition characteristics, or suitable population, it shall fall within the scope of the registration certificate, product label and package insert.
An advertisement for food for special medical purposes shall clearly indicate a suitable population. It shall also clearly state “Not suitable for non-target population”, and “Use under the guidance of a physician or clinical nutritionist”.
This post also appears on Links to global healthcare advertising guidelines under “China”.
If you find the article useful, please share it with your network. You can also contact us to let us know your comments.
Acurit Medical Communications Pty Ltd provides bilingual Chinese medical writing and translation services for the pharmaceutical and nutrition sector. We focus on English Chinese literature reviews on nutrition and pharmaceuticals to support marketing claims, regulatory and R&D.
