Lebanon has officially designated Korea as a reference country for pharmaceuticals, a move expected to significantly improve the environment for Korean drugmakers entering the Middle East market.
According to the Ministry of Food and Drug Safety (MFDS) on Tuesday, Lebanon's Ministry of Public Health designated Korea as a new reference country in the pharmaceutical sector on the 21st. Korea is the seventh country to receive such designation, following the Philippines, Paraguay, Egypt, Ecuador, Nigeria, and the United Arab Emirates (UAE).
The designation carries particular significance as it marks the first case based on Korea's inclusion in the World Health Organization (WHO) Listed Authorities (WLA). The MFDS completed its WLA listing for all regulatory functions for pharmaceuticals and vaccines last year.
Once designated as a reference country, local review procedures are simplified for pharmaceuticals approved in that country. In Lebanon's case, Korean-approved drugs will be eligible for fast-track review, partial exemption from manufacturing facility approval documents, and preferential treatment of 10 percent or more in drug pricing. As a result, Korean drugmakers are expected to shorten the time needed to enter the Lebanese market and secure pricing competitiveness.
The outcome is viewed as the result of a joint effort by the MFDS, the Ministry of Foreign Affairs, and the Embassy of the Republic of Korea in Lebanon. The embassy built a foundation of trust through consultations with local health authorities, while the MFDS presented Korea's regulatory framework and pharmaceutical approval cases to persuade the Lebanese side. The pharmaceutical industry and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association also supported the effort by sharing global approval cases for new drugs and biosimilars.
"This designation reflects international recognition of Korea's regulatory capabilities and expertise," MFDS Commissioner Oh Yu-kyoung said. "It will also contribute to expanding the global reach of K-pharma and biotech and diversifying the pharmaceutical supply chain."
