Korea, Mexico agree on drug standards deal

South Korea and Mexico signed an agreement in Mexico City Tuesday to mutually recognize each state’s pharmaceuticals qualification standards, a move expected to expedite the entry of Korean drugs into the Mexican market.

The deal will take effect once Mexico officially joins the Pharmaceutical Inspection Cooperation Scheme, an international body that sets an international manufacturing quality standard for new drugs. The U.S., European Union, Japan and Korea are among its members.

Though the exact timing is unknown, Mexico is “currently undertaking membership procedures to join the scheme in the near future,” Park Sun-im, a ministry official, told The Korea Herald.

Under the new deal signed between the Korean Ministry of Food and Drug Safety and Mexico’s health regulator Cofepris, Korean drugmakers will no longer need to complete a separate site inspection by the Mexican authorities when preparing to export their products to Mexico.

Previously, Korean drug makers had to pass an independent review by Mexico’s health regulators even after passing an inspection from domestic authorities — a process perceived as redundant and time-consuming, according to the ministry.

Moreover, local firms whose products are already being sold in Mexico will benefit from the deal by being subject to new inspections by Mexico every five years, instead of the current two years.

As of now, Korea exports 17 drugs to Mexico, including LG Life Sciences’ anemia drug Espogen and Boryung Pharmaceutical’s hypertension medication Kanarb.

The Drug Ministry expects the new deal to increase the net volume of Korean pharmaceutical exports to Mexico by at least $8 million annually, according to their survey of local drugmakers in the field.

“We welcome the new MOU as it eliminates one of several regulatory procedures involved in entering Mexican markets, expediting the market launch of new products by around two to three weeks,” said LG Life Sciences spokesperson Park Jun-hyung.

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