Pharmaceutical advertising regulation and medical device advertising in China

1.1 Medicines 

The main laws and regulations which are applicable regarding advertising of medicines in the People’s Republic of China (“PRC”) include the: 

• Advertising Law of the PRC;
• Regulations for the Administration of Advertising; Anti-unfair Competition Law;
• Measures for the Administration of Internet Advertising;
• Enforcement Guidelines for Absolute Terms in Advertising
• Drug Administration Law;
• Implementing Regulations of the Drug Administration Law; and
• Interim Administrative Measures for Censorship of Advertisements for Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purpose.

1.2 Medical devices 

The main laws and regulations which are applicable regarding advertising of medical devices in the PRC include the:

• Advertising Law of the PRC;
• Regulations for the Administration of Advertising;
• Anti-unfair Competition Law;
• Measures for the Administration of Internet Advertising;
• Enforcement Guidelines for Absolute Terms in Advertising
• Regulations on Supervision and Administration of Medical Devices;
• Measures for the Management of Medical Device Advertisements; and.
• Interim Administrative Measures for Censorship of Advertisements for Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purpose. 

Yes, there are other legal regimes that govern the advertising of medicine and medical devices in the PRC.

Code of practice covering all advertisements:

• The Industry Self-Regulatory Codes of China Advertising Association (“CAA”). 

2.1 Medicines 

Code of practice covering medicines:

• The Code of Practice of the R&D-based Pharmaceutical Association Committee (“RDPAC”).
• The Pharmaceutical Industry Compliance Management Practices-Appendix D (Normative Appendix) of China Pharmaceutical Industry Association (“ CPIA”).

2.2 Medical devices 

Code of practice covering medical devices:

• The Ethics with Interaction with Chinese Healthcare Professionals published by China Association for Medical Device Industry (“ CAMDI”).

3.1 Medicine 

Non-prescription drugs can be advertised to both the general public and healthcare professionals upon approval from the local provincial branches of the National Medical Products Administration (“ NMPA”) where the applicant (drug licence holder or authorised distributor, Chinese agent of imported drugs) is located. If the advertisement is to be announced out of the approved province, a record shall be filed with the local authorities located in the location that the advert is to be published. Please note that, if the advertisement only publicizes the name of a non-prescription drug, such approval is not required. 

Prescription drugs shall not be advertised on mass media or promoted in any other manner targeting the public. Prescription drugs may be advertised on the medical or pharmaceutical journals jointly approved by the National Health Commission and NMPA. The approval and record regimes for prescription drugs is the same as the corresponding regimes for non-prescription drugs. Similarly, if the advertisement only publicizes the name of a prescription drug, approval is not required. 

3.2 Medical devices 

Medical device advertisements are under a similar approval regime with the above-mentioned drug advertisements. There are no different requirements for advertisements targeting public and healthcare professionals. 

Yes. In the PRC, the law regulates prescription drugs and non-prescription drugs differently. 

For prescriptions-only medicine:

• Prescription drugs may be advertised in medical or pharmaceutical journals jointly approved by the National Health Commission and NMPA, but shall not be advertised in 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.
• Where the name of a prescription drug is the same as its trademark or business name of the manufacturer, the trademark or business name in question shall not be used on any media other than medical or pharmaceutical journals.
• 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”.

For over-the-counter 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 “Please consult the instruction or a pharmacist before purchase and use”. 

Where the name of a non-prescription drug is used in an activity, releasing the product name of the drug in question is sufficient. 

General restrictions on advertising medicines and medical devices can be divided into restrictions concerning products and restrictions concerning advertisements themselves. 

5.1 Medicines 

Restrictions concerning drugs

• It is strictly forbidden to make advertisements for anesthetics, psychotropic drugs, toxic drugs, radioactive drugs, pharmaceutical precursor chemicals, and drugs for drug addiction treatment.
• Formulations prepared by medical institutions, drugs that do not have a Drug Licence and drugs specifically required by the army may not be advertised.
• Prescription drugs may be advertised in medical or pharmaceutical journals jointly approved by the National Health Commission and NMPA, but shall not be advertised in mass media or promoted in any other manner targeting at the public.

Restrictions concerning advertisements for drugs 

• Adverts must include the general name of the drug, information, drug advertisement licence number and drug production licence number, and the name of the manufacturing or trading enterprise.
• The information provided should be true and in accordance with the law and the approved registration information. The advert must not contain any information that is false, unscientific, or a categorical assertion or warranty of any described function.
• The contents of a drug advert shall be subject to the drug‘s instructions for use approved by the NMPA. If a drug advertisement involves the name, indications, main functions, pharmacological action, or other content of the drug concerned, it must not go beyond the scope of the drug’s instructions for use.
• Adverts shall not be released in publications for minors or broadcasted in TV channels, programs or sections for minors.
• No adverts for drugs may fall under any of the following circumstances:
  • using, directly or in a disguised form, the names or images of state organs, officers of state organs, military units or personnel, or using the military equipment or facilities for advertising or publicity;
  • using the names or images of scientific research institutes, academic institutions, industry associations or experts, scholars, physicians, apothecaries, clinical nutritionists, patients, etc. for recommendation or demonstration;
  • expressing or implying the functions to treat all diseases, adapt to all symptoms, apply to all groups of people, the necessity for normal life and disease treatment, or other content, which violates scientific laws;
  • including any content which may cause the public to have unnecessary worries about and fears for their health conditions and diseases or to misunderstand that non-use of such product will result in a certain disease or aggravate conditions;
  • including the words “safety”, “safety, no toxic and side effects” or “little toxic and side effects”, expressing or implying “natural” ingredients which ensure the safety of the product, or other content;
  • including some inductive contents such as “hot product, shopping rush, on trial”, “necessity for a family, free treatment, free product”, comprehensive evaluation contents such as “appraisal, ranking, recommendation, designation, selection, award”, or guarantee contents such as “refund for invalidity, insured by an insurance company” so as to instigate consumers to arbitrarily or excessively use the drug, dietary supplement or food for special medical purpose;
  • including the name, address, contact information, diagnosis and treatment projects and diagnosis and treatment methods of a medical institution, and such medical services of the medical institution as free clinic services, medical consultation phone number, or supply of special clinic services; or
  • other contents which shall not be included in accordance with laws and administrative regulations.
• Any adverts for drugs shall not contain the following items: 
  • any assertion or guarantee for efficacy and safety; any statement on cure rate or effective rate;
  • comparison with the efficacy and safety of other pharmaceuticals or medical devices or with other medical institutions;
  • using advertisement endorsers to make endorsements or testimonials.

Please note that the above regimes apply for both the advertisements of non-prescription drugs to the general public and advertisements of prescription drugs for healthcare professionals only. 

5.2 Medical devices 

Restrictions concerning medical devices

• Adverts for devices of drug addiction treatment.
• Adverts for specific devices are forbidden by NMPA from manufacturing, trading or using.            Adverts for devices for medical institution’s internal use are prohibited.

Restrictions concerning advertisements for medical devices

• 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 be true and in accordance with the law and conform to the product certificate issued by the NMPA. Adverts must not contain false, exaggerated, misleading content. Adverts must be subject to the registration certificate or record-filing certificate approved by, or the product instructions registered by or filed with the competent medical products administration. If a medical device advertisement involves the name, scope of application, mechanism of action, structure and ingredients, or other content of the medical device concerned, it shall not go beyond the scope of the registration certificate or record-filing certificate, or the registered or filed product instructions.
• Medical devices may not target children. Adverts must not be published in children publications, media channels, programs or columns.
• No advertisements for medical devices may fall under any of the following circumstances:
  • using, directly or in a disguised form, the names or images of state organs, officers of state organs, military units or personnel, or using the military equipment or facilities for advertising or publicity;
  • using the names or images of scientific research institutes, academic institutions, industry associations or experts, scholars, physicians, apothecaries, clinical nutritionists, patients, etc. for recommendation or demonstration;
  • expressing or implying the functions to treat all diseases, adapt to all symptoms, apply to all groups of people, the necessity for normal life and disease treatment, or other content, which violates scientific laws;
  • including any content which may cause the public to have unnecessary worries about and fears for their health conditions and diseases or to misunderstand that non-use of such product will result in a certain disease or aggravate conditions;
  • including the words “safety”, “safety, no toxic and side effects” or “little toxic and side effects”, expressing or implying “natural” ingredients which ensure the safety of the product, or other content;
  • including some inductive contents such as “hot product, shopping rush, on trial”, “necessity for a family, free treatment, free product”, comprehensive evaluation contents such as “appraisal, ranking, recommendation, designation, selection, award”, or guarantee contents such as “refund for invalidity, insured by an insurance company” so as to instigate consumers to arbitrarily or excessively use the drug, dietary supplement or food for special medical purpose;
  • including the name, address, contact information, diagnosis and treatment projects and diagnosis and treatment methods of a medical institution, and such medical services of the medical institution as free clinic services, medical consultation phone number, or supply of special clinic services; or
  • other contents which shall not be included in accordance with laws and administrative regulations.
• Any adverts of medical devices shall not contain the following items:
  • any assertion or guarantee for efficacy and safety; any statement on cure rate or effective rate;
  • comparison with the efficacy and safety of other pharmaceuticals or medical devices or with other medical institutions;
  •  using advertisement endorsers to make endorsements or testimonials.

Medical devices may not target children. Adverts must not be published in children publications, media channels, programs or columns.

6.1 Medicines 

Please see above answer for Q5. 

6.2 Medical devices 

The main restrictions applicable to the advertising of medical devices to healthcare professionals are similar to the restrictions to the general public. Please see the answer for Q5. 

7.1 Medicines 

• Adverts shall prominently indicate contraindications and adverse reactions concerned. The contents to be prominently indicated in the adverts shall be in clearly visible and easily identifiable fonts and colors, and consistently appear in video adverts.
• Internet advertisements shall be identifiable and enable consumers to recognise them as advertisements.
• As mentioned above, advertisements for prescription drugs directed only to healthcare professionals for medicines shall include: 
  • The common name of the proposed drug; The warning;
  • Pharmaceutical advertisement approval number; Drug approval number;
  • The name of the drug manufacturer or trader;
  • Advertisements for prescription drugs shall further be prominently marked with the words "this advertisement is for medical and pharmaceutical professionals to read only". 

7.2 Medical devices

• The regulatory regime does not distinguish the requirements on the advertisements for the general public and healthcare professionals. The information that must appear in advertisements must include:
  • The approved name of the medical device;
  • The name of the medical device manufacturer;
  • The certificate number of the medical device; and
  • The medical device advertisement approval number.
• Further, advertisements for medical device products recommended for personal use must be marked: “Please read the product manual carefully or purchase and use it under the guidance of medical staff”. In case of contraindications or precautions in the registration certificate of a medical device, the advertisement shall prominently indicate the words "Detailed contraindications and precautions can be found in the instructions".
• The contents to be prominently indicated in the adverts shall be in clearly visible and easily identifiable fonts and colors, and consistently appear in video adverts.
• Internet advertisements shall be identifiable and enable consumers to recognise them as advertisements. 

8.1 Medicines 

As explained above, the requirements for the non-prescription drug adverts must be the same as the content of adverts set out in Q7. 

Those for over-the-counter (OTC) drugs shall further be prominently marked with the logo for OTC drugs and the words "please buy and use following the drug instructions or under the guidance of pharmacists". 

8.2 Medical devices 

Please see answers for Q7.

Any data, statistics, research result, summary, quotation and other quoted information used in an advertisement shall be authentic and accurate, with the source indicated. If the quoted information is subject to a scope of application or a valid period, the scope of application or valid period shall be clearly indicated. Regarding content specifying the rate of cure or effectiveness and content such as “research findings”, “experiments or data proofs” that cannot be scientifically proven, these should not be contained in the medicine advertisements or medical device advertisements.

Yes. Information about comparing the effectiveness or safety of the proposed drugs or medical devices with that of others must not be advertised. 

Yes. Measures for the Administration of Internet Advertising is a general regulation that covers all internet advertisement. In addition to the general rules for online advertising, direct communication such as E-mails and text messages that contain advertisements must only be sent with the consent of the receiver. The Measures for the Administration of Internet Advertising also provides specific rules for medical advertisement:

• Prescription drug advertisements are forbidden on the internet, unless otherwise stipulated by laws and administrative regulations.
• Medicines and medical devices cannot be published on the internet without examination and approval. For advertisements that are subject to examination and approval, they shall be strictly published according to the approved contents, and shall not be edited, spliced or modified. If changes need to be made to approved advertisement contents, a new application for advertisement examination shall be submitted.
• The internet or the social media postings shall not publish in disguised form advertisements for medical treatment, pharmaceuticals, medical devices and healthcare food by way of introducing knowledge on health or health maintenance or by other means.
• When introducing health or health maintenance knowledge, addresses, contact details, shopping links and other information about related medical institutions, pharmaceuticals, medical devices, healthcare foods, or special medical purpose foods shall not appear on the same page or at the same time.
• Advertisements detrimental to the physical and mental health of minors, including those for medical treatment, pharmaceuticals, healthcare foods, special medical purpose formula foods and medical devices shall not be published on internet media targeting minors. 

As mentioned above, the provincial level branches of NMPA will examine and approve the medical advertisements. The local branches of the State Administration for Market Regulation (“ SAMR”) of different levels will be in charge of the enforcement against any illegal advertisements, including supervising and punishing such illegal advertisements. 

Non-compliance advertisements may be subject to the liabilities below: 

• Civil liability for damaging the consumers’ interests. 
• Administrative liability including: 
  • An order for the cessation of the publishing of advertisements;
  • An order for the advertisers to eliminate the ill-effects within a specified corresponding scope;
  • Fines up to 2 million RMB or a multiple (3x10x) of total advertising fees (e.g. up to 5 times for foods making disease treatment or prevention claims);
  • Revocation of business licence;
  • Revocation of the approval for advertisement; and
  • Prohibition from publishing advertising for one year.
• Criminal liability
  • Fixed-term imprisonment of not more than two years of criminal detention; and/or            
  • Fine. 

In May 2023, the SAMR issued the Measures for the Administration of the Review of Advertisements for Drugs, Medical Devices, Health Foods and Foods for Special Medical Purposes (Draft for Public Comment) (the “Draft”), revising the Interim Administrative Measures for Censorship of Advertisements for Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purpose that has been implemented for over three years. 

If the Draft take effect, the following new restrictions will be applied to the Adverts for medicines and medical devices:

• New labeling and indication requirements. The Draft further requires medicine advertisements to conspicuously indicate generic names and medical device advertisements to indicate product names. Where full listing of contraindications and adverse reactions is not possible, main contents shall be indicated along with “see instructions for details”. All contents should be conspicuously indicated per law when ads are published.
• Expanded negative list of ad contents, newly prohibiting: (1) Use or disguised use of military unit names, troop numbers/codes, military-specific terms, military insignia patterns or similar; (2) Recommendations or endorsements under the name or image of consumer organizations; (3) Inciting arbitrary or excessive use of medical devices; (4) Theoretical references, viewpoints, literature citations, research reports, proof of experiments etc. beyond instructions; and (5) Use of minors to introduce the four product categories.
• Live streaming advertising. The Draft prohibits (i) disguised ads in live streams via health/wellness content introduction; and (ii) spokespersons recommending/endorsing the medicines and medical devices in live streams. 

The Draft also puts revisions for optimising rules and procedures for reviewing advertisements of medicines, medical devices, health foods and special medical purpose foods:

• provides time limits for review agencies processing applications to increase predictability;
• requires applicants to actively apply for cancellation if changes are made elements like functions, indications pharmacological effects and intended use etc., of medicines and medical devices;
• permits non-reapplication for certain non-substantive visual and peripheral changes;
• stipulates automatic invalidation of approval numbers if advertised medicines and medical devices are legally ordered to stop production/sales/use;
• exempts legally required medicines and medical devices information display on authorization holders’ , manufacturers’ and dealers’ own media from advertising review;
• mandates separate review applications for linked content in advertisements if that content is legally subject to mandatory review.