This is part of our series on the regulatory policies updates, reports and advertising laws – January update (RED Bans 29 apps), December update, November update, October update, Anti-monopoly crackdown, PIPL, Advertising law
TL;DR Pharmaceutical & Medical Devices advertising in China is very complicated, there are several different departments that are responsible for entire product lifecycle including marketing. Skip to the end to read a summary of some of the rules, dos & don’ts – this is by no means exhaustive, we will guide you through the entire process if you need to advertise in China for medicine or medical devices.
Read on for a deep dive into one of the toughest industries to advertise in China.
Advertising and promotion of pharmaceuticals and medical devices are subject to strict regulations in China. Approval requirements for advertisements and strict product labelling requirements are issues that multinational pharmaceutical and medical device manufacturers often need to be very conscious about.
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.
Advertisements for medical treatment, drugs, formula food for special medical purposes, medical devices, pesticides, veterinary drugs, and health food shall not be published without scrutiny and prior approval. In 2021, China classified medical beauty industry advertising as medical advertising. A new draft measures further stipulates that advertisements of medical treatment, drugs, formula food for special medical use, medical devices, or health food shall not be published through live steaming.
The main laws and regulations which are applicable regarding advertising of medicines & Medical devices in China include the following.
General Advertising laws:
Advertising Law of the PRC
Interim Measures for the Administration of Internet Advertising
Interim Administrative Measures for Censorship of Advertisements for Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purpose
The Industry Self-Regulatory Codes of China Advertising Association (“CAA”)
Medicine (pharmaceutical) Specific:
Drug Administration Law
Implementing Regulations of the Drug Administration Law
The Code of Practice of the R&D-based Pharmaceutical Association Committee (“RDPAC”)
Medical Devices Specific:
Regulations on Supervision and Administration of Medical Devices
Measures for the Management of Medical Device Advertisements
The Ethics with Interaction with Chinese Healthcare Professionals published by China Association for Medical Device Industry (“CAMDI”).
There are 4 distinct category of advertising depending on the type of product and the type of target audience of the advert. Rules differ for non-prescription drugs (or over-the-counter drugs) & prescription drugs. Depending on whether advertising to public or healthcare professional. Let us look at the distinctions below.
Over-the-counter or non-prescription medicines:
A non-prescription drug advertisement shall not contain difficult or confusing medical or pharmaceutical terms which may mislead the public about the effect and safety of the proposed drugs.
Non-prescription drugs can be advertised on mass media or promoted in other manners targeting the public.
A non-prescription drug advertisement must ensure that it is clearly non-prescription, by indicating in the advertisement the over-the-counter (OTC) logo.
The warning to be used in non-prescription drug advertisements must be “请按照药品购买说明，在药师指导下使用” (Please follow the drug purchase instructions and use it under the guidance of a pharmacist).
Prescriptions-only medicine:
Prescription drugs may be advertised on the medical or pharmaceutical journals jointly approved by the Ministry of Health and NMPA, but shall not be advertised on mass media or promoted in any other manner targeting at the public.
Pharmaceutical companies are prohibited from distributing medical or pharmaceutical journals which contain prescription drug advertisements to the public for free.
The name of a prescription drug or the trademark and business name which are registered with the name of a prescription drug shall not be used to name various events.
The warning to be used in prescription drug advertisements must be “This advertisement is for pharmaceutical professionals only”.
Advertising Pharmaceuticals to the Public
The Administrative Measures for Review of Drug Advertisements strictly prohibit advertising for several special categories of medicines:
narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs
pharmaceutical precursor chemicals and medicines for drug rehabilitation treatment
drugs specially needed by the military and preparations made by military medical institutions
pharmaceutical preparations made by healthcare institutions
no prescription-only medicines can be advertised in the mass media or promoted in any other manner targeting the general public
Pharmaceutical advertising must contain the drug’s contraindications, adverse reactions and drug advertisement approval number, and the name of the manufacturing or trading enterprise.
Adverts shall not be released in publications for minors or broadcasted in TV channels, programs or sections for minors.
Cannot contain assertions or guarantees of
efficacy and safety
specifications about the cure rate or efficacy rate
comparisons with other drugs
endorsement by a spokesperson
anything that is inconsistent with the approved instructions
Cannot containing words and expressions like "safe", "safe, non-toxic and with no side-effects" and "minor toxic side-effects"; or containing express or implied statements that the ingredients are "natural", thus ensuring safety
Cannot have contents that induce purchase such as "hot sales”, “rush to buy or use on a trial basis", "family necessities”, “free treatment” and “free gifts". For more comprehensive prohibited words, read our post on censorship
Advertising medical device to the Public
Adverts for specific devices are forbidden by NMPA from manufacturing, trading or using.
Adverts for devices for medical institution’s internal use are prohibited.
Adverts must contain the name of the approved medical device, the name of the manufacturing enterprise, registration certificate number and advertisement licence number.
All information must conform to the product certificate issued by the NMPA.
Advertising Pharmaceuticals to the Healthcare Professional
Both over-the-counter medicines and prescription-only medicines can be advertised to healthcare professionals
For prescription-only medicines that can only be advertised to healthcare professionals, the advertising should be marked “此广告仅供医疗和制药专业人士使用”in a prominent position.
In conclusion, Pharmaceutical & Medical Devices advertising in China is very complicated, there are several different departments that are responsible for entire product lifecycle including marketing. Reach out to us for deep-dive research into specific therapeutic areas or to activate advertising in China. In the meantime, here is a summary of some of the rules, dos & don’ts – this is by no means exhaustive, we will guide you through the entire process if you interested in advertising.
Pharmaceuticals Dos
Obtain pre-publication approval unless exemptions apply List product name, required legends, advertisement permit number, product manufacturing permit number and the drug manufacturer/distributor Always use generic product name in advertisements, generic product names must be displayed more prominently than the brand names
Pharmaceuticals Don’ts
use unscientific assertions or claims regarding efficacy or usage claims
conduct comparative advertising with similar products, or conduct “before and after” references for own product
use superlative language
use references to cure rate, efficacy rate or product awards.
use the name or images of medical institutions, academic institutions, doctors, and patients as testimonials to the advertised claims
publish advertisements on publications or press media that target minors or otherwise to appeal to minors, or advertise in the name of a minor
advertise for narcotics, psychotropic drugs, poisons for medical use, radio pharmaceuticals or drugs specially needed by the army
use unregistered trademark in drug advertisements
use registered trademarks together with generic product name