South Korea’s Drug Ministry said Thursday that it has officially joined the international pharmaceutical cooperation body ICH, a move expected to ease the entry of Korean pharmaceutical products into overseas markets.

The Korean Ministry of Food and Drug Safety is the sixth member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, which aims to establish a shared international standard across all stages of the pharmaceuticals regulation process.

“By joining the ICH, Korea has earned international recognition as a country with an advanced evaluation and regulation system for pharmaceutical products,” the ministry said in a statement.

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The ICH, launched in 1990 under the initiative of Europe, US and Japan to harmonize regulations, includes the world’s leading drug and health regulators. Members include the US Food and Drug Administration, the European Commission, Japan’s Pharmaceuticals and Medical Devices Agency, Health Canada and Switzerland’s Swissmedic.

Korea’s ICH membership is expected to bring benefits for Korean pharmaceutical exports. For one, Korean drugs will enjoy priority status during drug procurement bids in Vietnam and Hong Kong, while drug approval procedures will be partially simplified in countries in the Middle East and Taiwan, a ministry official told The Korea Herald.

“As a member of the ICH, Korea will also become an active contributor to shaping global pharmaceutical regulations -- an exclusive role held by the US, Europe and Japan, home to the world’s most advanced pharmaceutical industry, until now,” the official said. 


In addition to joining the ICH, the Korean Drug Ministry has struck a number of other partnerships with foreign drug regulators and industry stakeholders this year.

Earlier this month, the MFDS signed an agreement with the World Health Organization on shortening the certification period for Korean vaccines applying for the WHO’s prequalification approval.

Under the deal, the WHO will substitute its usual lengthy on-site investigation on Korean vaccine producers with the results of the Korea’s Good Manufacturing Practice inspection which ensures vaccines’ safety, effectiveness and availability.

Through this substitution, the WHO’s pre-qualification procedures for Korean vaccines will be shortened by more than six months, raising efficiency and expediting export procedures, the ministry said.

The Korean Drug Ministry also signed a deal with Mexico’s health regulator Cofepris in April, under which Mexico agreed to conduct GMP inspections on Korean drugs sold in Mexico every five years, instead of the previous two years.

This month, Peru’s Ministry of Health also agreed to adopt the Korean Pharmacopoeia as an official reference in addition to the US Pharmacopoeia and European Pharmacopoeia, according to the Korean Drug Ministry.

By Sohn Ji-young (jys@heralcorp.com)