Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

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

General Advertising Laws

Advertising Law of the People’s Republic of China
Regulations for the Administration of Advertising
Anti-Unfair Competition Law
Measures for the Administration of Internet Advertising
Enforcement Guidelines for Absolute Terms in Advertising

Specific Regulations – Medicines

Drug Administration Law
Implementing Regulations of the Drug Administration Law
Interim Administrative Measures for Censorship of Advertisements for Drugs, Medical Devices, Dietary Supplements, and Foods for Special Medical Purpose

Specific Regulations – Medical Devices

Regulations on Supervision and Administration of Medical Devices
Measures for the Management of Medical Device Advertisements

2. What are self-regulatory codes of conduct?

General Code

Industry Self-Regulatory Codes of China Advertising Association (CAA): This code applies to all advertising practices and sets general standards for ethical marketing communication.

Medicine-Specific Codes

Code of Practice of the R&D-based Pharmaceutical Association Committee (RDPAC): Provides guidance for advertising prescription drugs.
Pharmaceutical Industry Compliance Management Practices – Appendix D (Normative Appendix) of China Pharmaceutical Industry Association (CPIA): Outlines best practices for pharmaceutical marketing activities.

Medical Device-Specific Code

Ethics with Interaction with Chinese Healthcare Professionals (CAMDI): Focuses on ethical interactions between medical device companies and healthcare professionals, indirectly influencing advertising practices.

3. What are the Licenses, Approvals, and Fees for advertising medicines and medical devices?

Non-Prescription Drugs

Approval required from the local provincial NMPA branch where the applicant is located.
If advertising outside the approved province, a filing must be made with local authorities.
No approval required if the advertisement mentions only the drug name.

Prescription Drugs

Cannot be advertised in mass media or directly to the public.
May be advertised in medical or pharmaceutical journals approved by the National Health Commission and NMPA.
No approval required if the advertisement mentions only the drug name.

Medical Devices

Approval required from the local provincial NMPA branch.
Same approval requirements apply to public and healthcare professional advertising.

Fees

The regulations do not explicitly specify approval fees. Consultation with the NMPA is advised for confirmation.

4. What is the difference in regulation between prescription-only and over-the-counter medicines?

Prescription-Only Medicines (POMs)

Can only be advertised in approved medical or pharmaceutical journals.
Advertising in mass media or public-facing platforms is prohibited.
Journals containing POM ads cannot be freely distributed to the public.
If the drug name is also a trademark or business name, it cannot be used in public media.
Drug names or trademarks cannot be used to name events or promotions.
Mandatory warning: “This advertisement is for pharmaceutical professionals only.”

Over-the-Counter Medicines (OTCs)

May be advertised broadly in mass media and public platforms.
OTC logo must be prominently displayed.
Advertisements must avoid complex medical terminology that could mislead consumers.
Mandatory advisory: “Please consult the instruction or a pharmacist before purchase and use.”
Using the OTC drug name for events or promotions requires only name disclosure.

5. What are the restrictions on advertising medicines and medical devices to the general public and healthcare professionals?

Medicines – General Restrictions

No advertising for anesthetics, psychotropic drugs, toxic drugs, radioactive drugs, pharmaceutical precursor chemicals, or addiction treatment drugs.
No advertising for drugs prepared by medical institutions without a Drug Licence or drugs required specifically by the army.
Prescription drugs may only be advertised in approved medical or pharmaceutical journals.

Medicines – Advertisement Content Restrictions

Must include general drug name, information, advertisement licence number, production licence number, and manufacturer or trader name.
Information must be true, legal, and consistent with approved registration details.
No false or unscientific claims or guaranteed functions.
No advertising in children’s publications or children’s TV channels.
No use of state or military names or images, scientific or medical endorsements, all-disease cure claims, safety guarantees, inducements to overuse, or comparative efficacy statements.
No use of advertisement endorsers.

Medical Devices – Restrictions

No advertising for addiction treatment devices, NMPA-forbidden devices, or devices for internal use in medical institutions.
Must include device name, manufacturer name, registration certificate number, and advertisement licence number.
Advertising content must match the scope of the registration certificate or filed instructions.
No advertising in children’s publications or children’s TV channels.
Same prohibitions as medicines regarding endorsements, safety guarantees, inducements, and comparative claims.

6. What information is required in advertisements directed only at healthcare professionals?

Medicines

Common name, pharmaceutical advertisement approval number, and drug approval number.
Name of the drug manufacturer or trader.
Contraindications, adverse reactions, and mandatory warning: “This advertisement is for medical and pharmaceutical professionals to read only.”
Information must be clearly visible and easily identifiable.
For video ads, required information must appear consistently.
Must be clearly identifiable as advertisements.

Medical Devices

Approved device name, medical device advertisement approval number, and certificate number.
Name of the medical device manufacturer.
Usage warning for personal devices: “Please read the product manual carefully or purchase and use it under the guidance of medical staff.”
If applicable, contraindication notice: “Detailed contraindications and precautions can be found in the instructions.”
Information must be clearly visible and consistent in video advertisements.
Must be clearly identifiable as advertisements.

7. What are the requirements for scientific data in advertisements for medicinal and medical device products?

All data, statistics, research results, and quotations must be authentic and accurate.
Sources must be clearly indicated.
Any scope of application or validity period of the data must be clearly stated.
No claims specifying cure rates or effectiveness.
No unscientifically proven claims such as “research findings” or “data proofs.”
Data must be scientifically valid and must not support unsubstantiated claims.

8. Are there specific rules for comparative advertising of medicines and medical devices?

Yes. Information comparing the effectiveness or safety of medicines or medical devices with others must not be advertised.

9. How to advertise medicines and medical devices on the internet and social media?

General Internet Advertising Rules

Direct advertising emails or messages require recipient consent.
All online advertisements must comply with general advertising laws.

Specific Rules

Prescription drug advertising on the internet is generally prohibited.
Advertisements must be examined and approved before online publication.
Approved advertisements must not be edited or modified without reapproval.
Medical advertisements must not be disguised as health or wellness information.
Health education content must not include purchase links or contact information.
Advertisements harmful to minors are prohibited on platforms aimed at minors.

10. What are the enforcement mechanisms and legal consequences?

Enforcement Authorities

National Medical Products Administration (NMPA) and provincial branches
State Administration for Market Regulation (SAMR)

Penalties

Civil liability for consumer harm.
Orders to stop illegal advertisements.
Mandatory correction or elimination of adverse effects.
Fines up to RMB 2 million or multiples of advertising costs.
Revocation of business licences or advertisement approvals.
Prohibition from advertising for up to one year.
Criminal penalties including imprisonment of up to two years.

11. Any future developments in China?

In May 2023, the State Administration for Market Regulation (SAMR) released Draft Measures for the Administration of the Review of Advertisements for Drugs, Medical Devices, Health Foods, and Foods for Special Medical Purposes.

Key Proposed Changes

Mandatory display of generic drug names.
Expanded list of prohibited advertising content.
Restrictions on live-stream advertising and spokesperson endorsements.
Optimized review timelines and procedures.
Automatic invalidation of advertisement approvals if products are ordered to cease use.
Exemptions for legally required information displayed on manufacturers’ own media.

How can OMC help?

Professional review of marketing and advertising materials with detailed reports.
Services to obtain authority approvals where required.
Translation of marketing materials by a professional translation agency certified with ISO 17100.