A global healthcare advertising guidelines and guidances resource for medical writers and healthcare advertising agencies around the world.
This global healthcare advertising guidelines resource will continue to be updated over the coming months to include links to guidelines from other countries.
Click on the country that you are looking for to jump directly to that section:
The Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG) contains links to the Therapeutics Goods Advertising Code and multiple guidance for various advertising situations.
The Australia Government Advertising Hub “brings together news and information about the regulation of therapeutic goods advertising. It contains tools for both consumers and advertisers, including fact sheets, e-learning modules and forms for reporting unlawful advertising and for submitting enquiries.”
A detailed Advertising Compliance Checklist can be used to ensure that you have not left any stone unturned when it comes to following the regulations in your consumer advertising.
In Canada, pharmaceutical advertising targeted to healthcare professionals is allowed, but there are guidelines to follow. Promotional direct-to-consumer advertising of prescription products is not allowed in Canada. Only the prescription product name, price and quantity are acceptable information that can be promoted to patients.
There are two 3rd party pre-clearance reviewer agencies that are recognized by Health Canada for vetting Canadian healthcare and pharmaceutical advertisements. Both have a specific mandate. They are the Pharmaceutical Advertising Advisory Board (PAAB) and Advertising Standards Canada. Both reviewers ensure that content is in sync with the Health Canada food and drugs advertising regulations.
The PAAB reviews advertising for prescription products, non-prescription pharmaceutical products, biologicals, natural health products and homeopathy products.
PAAB reviewers give guidance to help Canadian medical marketers revise the copy and design until the entire promotional piece is deemed to be in accordance with local regulatory requirements. Once the advertisement is completely within the requirements, PAAB provides the pharma company with an approval number and the right to affix the PAAB logo onto the advertising piece (a symbol meant to reassure HCPs and patients that the content that they are reading has been vetted by a 3rd party for credibility, accuracy and completeness). The PAAB code can be found at https://code.paab.ca/. An official forum with questions and answers managed by PAAB can be found at https://forum.paab.ca/.
On the other hand, Ads Standards reviews consumer-directed nonprescription drug advertising, natural health product advertising, vaccine advertising, medical device advertising, and prescription drug direct-to-consumer-advertising and direct-to-consumer-information. Similarly to the PAAB logo which symbolizes that the materials have been reviewed and approved by a neutral third party, Ad Standards also provides a logo that can be affixed to advertising materials that have been reviewed by and received approval from Ad Standards Clearance Services.
In China, when an advertisement published by various media or outlets contains a drug name, drug indications or other contents related to a drug, it is considered a drug advertisement. It shall be approved according to The Measures For Vetting Drug Advertisements (link in Chinese) issued by the State Administration for Market Regulation (SAMR).
There is no need for approval if: Over-The-Counter drugs only advertise the name of a drug, or prescription drugs only advertise the name of a drug on medical and pharmaceutical journals. Provincial-level medical products administrations vet drug advertisements within their respective administrative areas. They will issue an approval number for a drug advertisement that has been vetted. The approval is valid for one year. Industrial And Commercial Administrations at or above county levels supervise drug advertising after its approval.
Contributor: Amanda Mao, PhD
International Comparative Legal Guides has compiled a comprehensive document in July 2020 covering the advertising landscape in India. Link to the article Full credit to Mr. Krishna Venkat for this document.
Primarily, there are no sign-offs in India for the advertisement of pharmaceutical copy. There is no legally prescribed standard operating protocol governing advertising activities.
On December 12, 2014, the Department of Pharmaceuticals (DoP) prepared a voluntary code of marketing practices called the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP). Sections 2 and 3 covered the “Claims and comparisons” and “Textual and Audio-visual promotional material”, respectively. Owing to the voluntary nature of the code, the DoP sought to make the code mandatory so that compliance to the code by pharma companies would be legally obligated.
In July 2017, the DoP sent the draft Essential Commodities (Control of Unethical Practices in Marketing of Drugs) Order, 2017 (“Order“) to the Law Ministry for final clearance. There are differences between the code and the proposed Order and are captured in Annexure C of a whitepaper here. The draft is not available on the public domain. The Law Ministry has rejected the idea of the draft’s placement under Essential Commodities Act.
In August 2019, a report by a non-governmental organization alleged that medical representatives bribed health care professionals with foreign trips, expensive smartphones, e-vouchers, credit cards and even sexual favors. Four months later, in December 2019, the secretary of the DoP, P.D. Vaghela, conducted a review meeting with the Indian Drug Manufacturers’ Association, the Indian Pharmaceutical Alliance and the Organization of Pharmaceutical Producers of India. The issue of non-compliance with the UCPMP guidelines was brought up.
In 2020, the UCPMP still remains a voluntary code- toothless and unenforceable– and rampant violations occur but cannot result in prosecution of wrong-doers.
In New Zealand, pharmaceutical companies can promote to both HCPs and patients.
The industry association for prescription medicines, Medicines New Zealand, publishes the Medicines New Zealand Code of Practice, applicable to both member and non-member companies. The ‘code’ covers advertising to both HCPs and consumers.
All material intended for use by consumers or patients must be reviewed and approved by TAPS (Therapeutic Advertising Pre-vetting Service) for compliance with the Advertising Standards Association Therapeutic and Health Advertising Code and legislation. TAPS also provide advice to advertisers and guidance on specific topics. HCP content can be reviewed and approved by an internal company employee, acting as a delegated authority of TAPS (known as TAPS DA).
Medsafe, the New Zealand health regulatory agency, publishes a Guideline on the Advertising of therapeutic products, summarising the requirements of the New Zealand Medicines Act, Medicines Regulations and Misuse of Drugs Act which all contain information relevant to the advertising of medicines.
Contributor: Erin Gentry
Advertisements of therapeutic products to the general public and healthcare professionals do not require prior approval from the Health Sciences Authority (HSA), the governing body for regulations that apply to medical products in Singapore.
The rules and requirements for advertising of therapeutic products prohibit advertising of unregistered product, unregistered indication for a specific product, material aimed at children below 14 years of age, promotions suggesting monetary reimbursements for use of product, false claims of endorsement by public authorities. The rules prohibit advertisements by healthcare professions or celebrities. Use of logos of HSA or affiliated groups is also not allowed.
Advertisements of prescription medicines to the general public is prohibited, which means advertisements in waiting areas of clinics and hospitals are not allowed. Advertising copy making claims of better efficacy in comparison to other products is also not allowed. The regulations specify that no claims of cures or preventions of a list of about 20 diseases and conditions is allowed. This list diseases and conditions like cancer, diabetes, blindness, deafness, sexual function and hypertension. Samples of therapeutic product alone or other health products along with therapeutic product are not to be provided to the general public. Any direct-to-consumer advertisements of pharmacy-only medications should include advisories to patients to read information leaflets and to consult their doctor if symptoms persist.
Advertising to Health Care Professionals are allowed as long as the information is not open to the general public. Any advertisements of products relating to the above mentioned list of conditions must be non-promotional. Comparative claims are allowed in advertisements that are limited to HCPs.
Advertisements of any unregistered product or unapproved use can only be made in the form of a scientific publication, conference presentation, or pharmaceutical trade exhibition which is not open to the general public. Any such advertisement of unregistered product can indicate the purpose and efficacy of the product. Unregistered products must contain a statement that is not registered in Singapore and must be registered in at least one other country.
Advertisements of Homeopathic, Traditional Indian, Malay, or Chinese proprietary medicines require a valid permit. These rules also apply to personal care products such as medicated soaps and toothpastes. Vitamin and mineral supplements, medicated oils and balms also require a permit.
Such advertisements have to include the permit number in the promotion materials and cannot be amended without prior approval by HSA.
Permits are not required for advertising that is directed to traders (who can lawfully sell these products) and HCPs.
No promotional sample distributions are allowed as part of advertising strategy.
Contributor: Bhavana Achary
The US Food and Drug Administration (FDA) provides guidance regarding advertising healthcare products in the United States. The Federal Food, Drug and Cosmetics Act, several guidances as well as enforcement actions can be found here.
I would like to thank the contributors who are helping me make this resource possible. This could not be done without their expertise and initiative.
Help make this resource more helpful to others. If you are an expert in your country’s healthcare marketing guidelines and that particular country is not listed below, or information is lacking, then please send me a direct message on LinkedIn informing me that you would like to be a contributor to this resource.
Updated on October 18, 2020.