Pharmaceutical advertising regulation and medical device advertising in China

  1. 1. Which laws are applicable regarding advertising of medicines and medical devices?
  2. 2. Are there any other legal regimes such as self-regulatory codes of conduct that govern the advertising of medicines and medical devices?
  3. 3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?
  4. 4. Does the law in China regulate the advertising of prescription-only and over-the-counter medicines differently?
  5. 5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?
  6. 6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?
  7. 7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?
  8. 8. What information must appear in advertisements directed to the general public?
  9. 9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?
  10. 10. Are there specific rules for comparative advertisement of medicines and medical devices?
  11. 11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?
  12. 12. Please describe the enforcement mechanism. Which bodies monitor compliance with the advertisement provisions and what are the legal consequences (e.g. penalties) for non-compliance?
  13. 13. Any future developments in China?

1. Which laws are applicable regarding advertising of medicines and medical devices?

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;
  • Interim Measures for the Administration of Internet Advertising;
  • Drug Administration Law;
  • Implementing Regulations of the Drug Administration Law;
  • Measures on the Examination and Approval of Drug Advertisements; and
  • Standards for Examining and Publication of Drug Advertisements.

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;
  • Interim Measures for the Administration of Internet Advertising;
  • Regulations on Supervision and Administration of Medical Devices;
  • Standards for Examining and Publication Medical Device Advertisements;
  • Measures on the Examination and Approval of Medical Devices Advertisements; and

Measures for the Management of Medical Device Advertisements.

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”).

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. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?

3.1 Medicines

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.

4. Does the law in China regulate the advertising of prescription-only and over-the-counter medicines differently?

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

For 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.
  • 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.

5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?

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 and radioactive drugs.
  • Formulations prepared by medical institutions, drugs that do not have a Drug Licence and drugs specifically required by the army may not be advertised.
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.
  • Adverts shall not be released in publications for minors or broadcasted in TV channels, programs or sections for minors.

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

5.2 Medical devices

Restrictions concerning medical devices
  • 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 conform to the product certificate issued by the NMPA.

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

6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

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. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?

7.1 Medicines

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; and
  • The name of the drug manufacturer or trader.

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”.

8. What information must appear in advertisements directed to the general public?

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.

8.2 Medical devices

Please see answers for Q7.

9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?

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.

10. Are there specific rules for comparative advertisement of medicines and medical devices?

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

11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?

Yes. Interim 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 Interim Measures for the Administration of Internet Advertising also provides specific rules for medical advertisement: 

  • Medicines and medical devices cannot be published on the internet without examination and approval.
  • 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.

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.

13. Any future developments in China?

The SAMR issued the draft Administrative Measures for Censorship of Advertisements for Drugs, Medical Devices, Health Food and Foods for Special Medical Purpose (“Draft”) for public comments on 6 June 2019. The Draft will be open for public comment until 26 June 2019. 

The Draft was an overall regulation, which unified the different regulations that apply to advertisements of different medical products. According to the Draft, the competent regulatory authority for such advertisements is the SAMR and its provincial local branches. The Draft provided the standards of reviewing such advertisements, which generally clarified what can and cannot be contained in an advertisement and the kind of products prohibited from advertising. The Draft also set up an online unified review and approval process for the advertisements of different products and also established a publication regime, which publishes the advertisements approved for public viewing.

Picture of Nick Beckett
Nick Beckett
Managing Partner
Beijing
Roxie Meng
Associate
Beijing