Ministry of food and drug safety

Ministry of food and drug safety

home > Information > News&Notice > News&Notice
News&Notice|News&Notice|Information|Minisry of Food and Drug Safety


[Press Release, Aug. 14] MFDS restricts new approvals of psychotropic appetite suppressant
  • Registration Date 2020-09-08
  • Hit 299
[Press Release, Aug. 14 / Unofficial translation]

MFDS restricts new approvals of psychotropic appetite suppressant
- A concern regarding the abuse continuously raised…Amfepramone· Mazindol, additionally designated as restricted ingredients -

□ The Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-Kyung) announced that it would restrict new approvals of “Amfepramone” and “Mazindol”, the two psychotropic appetite suppressant, on August 14.
○ The restriction is the act responding to the public safety concerns on drug abuse arose from the increasing use of appetite suppressant defying efforts to ensure proper use.
※ Production Volume (10,000 pills): 242,413 (in 2017) → 256,628 (in 2018) → 283,042 (in 2019)
※ The number of patients who used appetite suppressant: 1.28 million (July 1, 2019 ~ May 31, 2020)

- For reference, other appetite suppressant including “Phentermine” and “Phendimetrazine” were designated as restricted ingredients in 2013. Due to this measure, new approvals of all ingredients of appetite suppressant are restricted.
- However, new formula and products for export, among others can newly get approvals regardless of this measure.

○ The MFDS explained the need to tighten up the control of these drugs at a meeting with industry officials and listened to their opinions before making the decision.

□ The MFDS stated that it will continue to prevent drug misuse and abuse by strengthening the cooperation with related organizations and industries as well as promoting public relations activities and additional safety measures for experts to ensure their safe use and proper prescription of medical drugs.

○ “Notice of approval restriction” is available at “The MFDS webpage (” → “Information” → “News/Notice” → “Notice”.
Attached File Attach all down
  • 8.14 psychotropic appetite suppressant.pdf Download

Division 국제협력담당관

Written by 배성명

Telephone 043-719-1559