Advertising Atlas ／ China
Advertising regulation in China
Regulator: NMPA ／ Basis: 広告法／薬品管理法
- Claims of efficacyAdvertisements for medical services, drugs and medical devices must not contain assertions or guarantees of efficacy or safety, nor state cure rates or effectiveness rates, and the content of a drug advertisement must not be inconsistent with the package insert approved by the drug regulator.
- Comparative advertisingAdvertisements for medical services, drugs and medical devices must not contain comparisons with the efficacy or safety of other drugs or medical devices, or with other medical institutions.
- Safety informationA drug advertisement must prominently state the contraindications and the adverse reactions.
- Direct-to-consumerNarcotic, psychotropic, medically toxic and radioactive drugs and other special drugs, drug precursor chemicals and detoxification products may not be advertised at all, and other prescription drugs may only be advertised in medical and pharmaceutical professional publications jointly designated by the State Council health administration and the State Council drug regulator.
- Materials for HCPsA prescription drug advertisement must prominently bear the statement 'this advertisement is for reading by medical and pharmaceutical professionals only' (Advertising Law article 16(3) and article 5(2) of the Interim Measures for the Administration of the Review of Advertisements for Drugs, Medical Devices, Health Foods and Formula Foods for Special Medical Purposes). Article 22 of the Interim Measures provides that, apart from the products for which advertising is prohibited outright by article 21, advertisements for prescription drugs may be published only in the medical and pharmaceutical professional publications jointly designated by the health administration department and the drug regulatory department of the State Council; it also forbids using the name of a prescription drug to title or sponsor activities, and forbids using a trade mark or company trade name identical to a prescription drug name in media other than those professional publications as a disguised form of advertising. Article 2(2) forbids publishing such advertisements without review; article 9 requires the advertisement approval number to be prominently shown; article 16 requires the review to be completed within ten working days of acceptance; and article 20 requires publication exactly as approved, without editing, splicing or modification. Article 11(2) prohibits using the name or image of research institutions, academic bodies, trade associations, or of experts, scholars, physicians, pharmacists, clinical dietitians or patients, as a recommendation or proof. Article 21 prohibits advertising altogether for narcotic drugs, psychotropic drugs, medicinal toxic drugs, radiopharmaceuticals, precursor chemicals, drugs and devices for treating drug dependence, drugs for special military needs and preparations compounded by military medical institutions, and preparations compounded by medical institutions. Under article 29, a breach of article 11(1), article 21 or article 22 is punished in accordance with article 57 of the Advertising Law.
- Pre-clearanceAdvertisements for medical services, drugs and medical devices must be reviewed as to content by the advertising review authority before publication, and may not be published without such review.
- Digital and socialIt is prohibited to publish prescription drug advertisements via the internet, unless laws or administrative regulations provide otherwise.
- EnforcementPublishing a medical, drug or medical device advertisement in breach of article 16 attracts an order to stop publication and eliminate the effects, a fine of one to three times the advertising cost (or 100,000 to 200,000 yuan where the cost cannot be calculated), and in serious cases three to five times the cost (or 200,000 to 1,000,000 yuan), possible revocation of the business licence, revocation of the advertising approval document and refusal to accept further advertising review applications for one year.
Every cell carries a summary, a source and a date checked. Topics whose source has not been verified are left marked “not researched” rather than filled with plausible text. Directives and statutes bind as to the result; what applies in practice is national implementing law. This is a research aid, not legal advice.