Updated weekly ・ last 2026-10-03JAEN
Pharma Promotion / Korea

Promotion of prescription medicines — Korea

Regulator: 食品医薬品安全処（MFDS） ／ Main law: 薬事法・医薬品等の安全に関する規則

The basics (source-verified)

Pre-review & approval

A 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.

Source: Rules on the Safety of Drugs, etc. (Korea), articles 79-82; Pharmaceutical Affairs Act article 68-2（checked 2026-09-23）

Promotion to HCPs

The 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.

Source: Rules on the Safety of Drugs, etc. (Prime Minister's Ordinance, Korea), article 78(1), items 2 and 3 (in force 2026)（checked 2026-09-23）

Direct-to-consumer

It 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.

Source: Pharmaceutical Affairs Act (Korea), article 68(6)（checked 2026-09-23）

Digital & social media

The 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.

Source: Rules on the Safety of Drugs, etc. (Korea), article 78(2) item 3 and article 79(1) items 1 and 3（checked 2026-09-23）

Efficacy claims

False 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.

Source: Pharmaceutical Affairs Act (Korea), article 68(1), (3) and (5) (in force 11 September 2026)（checked 2026-09-23）

Safety information

For 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.

Source: 의약품 등의 안전에 관한 규칙 [별표 7] 의약품등을 광고하는 경우에 준수하여야 할 사항 (제78조제3항 관련), items 1.가, 2.다, 2.차 and 2.거 — Rules on the Safety of Drugs etc., Annex 7 [in force 5 March 2026, Prime Minister's Ordinance No. 2100] (Korean)（checked 2026-09-23）

Comparative claims

In 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.

Source: 의약품 등의 안전에 관한 규칙 [별표 7] 의약품등을 광고하는 경우에 준수하여야 할 사항 (제78조제3항 관련), items 2.마, 2.자 and 3.라 — Rules on the Safety of Drugs etc., Annex 7 [in force 5 March 2026, Prime Minister's Ordinance No. 2100] (Korean)（checked 2026-09-23）

Enforcement & penalties

A 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.

Source: Pharmaceutical Affairs Act (Korea), articles 68, 68-2, 76(1), 93, 94, 95, 96, 97 and 98 (Korean text, law.go.kr)（checked 2026-09-23）

Laws & regulations 1

Notices & guidance 4

Industry codes & rules 0

Litigation 5

Case law 0

Legal commentary 1

Industry-association papers 16

See all →