Korea

Advertising regulation in Korea

Regulator: MFDS ／ Basis: 薬事法

Claims of efficacyFalse or exaggerated advertising about the name, manufacturing method, efficacy or performance of a drug is prohibited, advertising by means of articles, photographs, designs or other implicit methods suggesting efficacy or performance is prohibited, and no advertising of the name, manufacturing method, efficacy or performance may take place before the product has received approval or variation approval or has filed the required notification.
Comparative advertisingIn advertising a drug it is prohibited to make an advertisement that disparages another product, or that is suspected of disparaging it, irrespective of whether the content is true, and it is prohibited to advertise efficacy or performance with content such as 'this is definitely guaranteed' or with absolute expressions such as 'the best' or 'the finest'; for quasi-drugs, comparative statements about competing products must be made in accordance with the facts and exclusive absolute expressions such as 'the best' or 'the finest' may not be used.
Safety informationFor a drug that has adverse reactions, no advertisement may use expressions that deny those adverse reactions or that unduly emphasise safety; matters prescribed by the Commissioner of the Ministry of Food and Drug Safety must be displayed so that the drug is not misused or abused; and advertisements may not display the symptoms of a disease related to the efficacy, or scenes of surgery, in a threatening manner, nor display or suggest the indication in threatening terms.
Direct-to-consumerIt is prohibited to advertise prescription drugs, over-the-counter drugs having the same dosage form, route of administration and main ingredient content per unit dosage form as a prescription drug, and active pharmaceutical ingredients.
Materials for HCPsThe prohibition on advertising prescription drugs does not apply to advertising in professional pharmaceutical media aimed at medical and pharmaceutical experts, or to advertising using media or means of an academic character aimed at such experts.
Pre-clearanceA manufacturer, marketing authorisation holder or importer that intends to advertise a drug through newspapers, internet newspapers, periodicals, television or radio broadcasting, the internet, or media designated by the MFDS Commissioner must obtain prior review by the delegated advertising review body.
Digital and socialThe internet and computer communications are listed in the ordinance as media for advertising drugs, and drug advertising via internet newspapers and via the internet is subject to mandatory prior review.
EnforcementA person who violates article 68 of the Pharmaceutical Affairs Act (prohibition of exaggerated advertising) is punishable under article 95(1) item 10 by imprisonment for up to one year or a fine of up to 10 million won, and article 95(2) allows imprisonment and the fine to be imposed together. Under the dual-liability provision in article 97, where a representative or employee of a corporation commits an article 95 offence in connection with the business, the corporation or individual is also fined under that article, unless it did not neglect due care and supervision. As to administrative sanctions, article 76(1) provides that where a manufacturer of drugs, a holder of an item authorisation, a registrant of an active ingredient, an importer, a holder of clinical trial plan approval, a pharmacy founder, a drug seller or a drug sales-promotion operator falls under any of the listed grounds - which include item 3, 'where this Act or an order under this Act has been violated' - the Minister of Food and Drug Safety, or the mayor or head of the county or district, may revoke the authorisation, approval or registration, revoke acceptance of a notification, order closure of the consigned manufacturing and marketing site or the manufacturing site, order closure of the business office, prohibit the manufacture or import of the item, or order suspension of all or part of the business for up to one year. Article 68-2 further provides that a drug manufacturer, holder of an item authorisation or importer who intends to advertise a drug it has manufactured or imported must undergo review by the Minister of Food and Drug Safety as prescribed by Prime Ministerial Decree, and that the Minister may entrust that review to a corporation established under article 67.

Every cell carries a summary, a source and a date checked. Topics whose source has not been verified are left marked “not researched” rather than filled with plausible text. Directives and statutes bind as to the result; what applies in practice is national implementing law. This is a research aid, not legal advice.