The Ministry of Food and Drug Safety on Jan. 20 announced its recognition by the Emirates Drug Establishment (EDE), the medical and pharmaceutical watchdog of the United Arab Emirates, as an official reference regulatory authority for medical products. Shown is a bilateral meeting with the EDE at the ministry's regional office in Seoul's Yangcheon-gu District. (Ministry of Food and Drug Safety)

By Lee Dasom

The Ministry of Food and Drug Safety on Jan. 20 said it received on Jan. 16 recognition from the Emirates Drug Establishment, the official watchdog of the United Arab Emirates (UAE) for medical and pharmaceutical products, as a reference regulatory authority for medical products.

The accreditation is considered a tangible outcome of a memorandum of understanding on biohealth cooperation concluded on Nov. 18 last year the occasion of a bilateral summit, attesting to the reliability of Korea's regulatory system.

Korean companies can now apply for UAE approval with just a sales permit from the ministry instead of first needing review by the U.S. Food and Drug Administration or the European Medicines Agency.

This will also cut the time needed to enter the UAE market by shortening the review period, simplifying screening procedures and lifting the requirement of on-site inspection of production facilities.

The ministry said the UAE recognized Korea's regulatory capacity at the level of advanced counterparts. The scope of recognition also covered all medical products ranging from general medicine and biopharmaceuticals to medical devices.

Minister of Food and Drug Safety Oh Yu-Kyoung said, "Our ministry's regulatory capacity and expertise are officially recognized by a core Middle Eastern country, so we will actively back the global expansion of K-biohealth products including pharmaceuticals, medical devices and cosmetics."

dlektha0319@korea.kr