Pre-clearance
Korea ／ MFDS
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.
製造業者・品目許可取得者または輸入者が新聞、インターネット新聞、定期刊行物、テレビ・ラジオ放送、インターネット、食品医薬品安全処長が告示する媒体を用いて医薬品を広告しようとする場合、広告審議機関の事前審議を受けなければならない。
Note
Article 79(1)(1) excludes media or means that convey specialised content to, or have an academic character for, medical and pharmaceutical experts. Article 79(2) allows advertising without review in the print media of item 1 where the advertisement carries only the company name, the approved or notified product name and the drug's efficacy, indications, dosage and administration, subject to prior notification to the review body. Article 80 gives a 10-day decision period and a 10-day appeal route; article 82 requires the advertisement to display that it was reviewed. The statutory basis, Act article 68-2, was read separately at https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%95%BD%EC%82%AC%EB%B2%95/%EC%A0%9C68%EC%A1%B0%EC%9D%982 . Whether any constitutional challenge has affected this pre-review scheme was not investigated.
Article 79(1)(1) excludes media or means that convey specialised content to, or have an academic character for, medical and pharmaceutical experts. Article 79(2) allows advertising without review in the print media of item 1 where the advertisement carries only the company name, the approved or notified product name and the drug's efficacy, indications, dosage and administration, subject to prior notification to the review body. Article 80 gives a 10-day decision period and a 10-day appeal route; article 82 requires the advertisement to display that it was reviewed. The statutory basis, Act article 68-2, was read separately at https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%95%BD%EC%82%AC%EB%B2%95/%EC%A0%9C68%EC%A1%B0%EC%9D%982 . Whether any constitutional challenge has affected this pre-review scheme was not investigated.