LSK Global is 1st Korean CRO firm in Europe

LSK Global PS has become the first pharmaceutical contract research organization (CRO) in Korea to establish a pharmacovigilance agency in the European Union (EU).

The local CRO said Thursday that it has set up a new branch in Warsaw, Poland, that collects, detects, assesses, monitors and prevents adverse effects of pharmaceutical products researched in the EU. The newest drug safety unit will be responsible for monitoring and evaluating clinical trial processes for drugs being tested throughout the continent.

Pharmacovigilance refers to the process of identifying hazards in pharmaceutical products and reducing the risk of them inflicting damage to patients. Pharmaceutical companies are obligated to conduct comprehensive drug safety tests and pharmacovigilance audits prior to applying for approval to a local drug regulatory authority.

With the establishment of the new agency in Warsaw, LSK Global PS will work with the European Medicines Agency to create a comprehensive tracking system for all drugs being made and tested in EU.

“As the pharmacovigilance area becomes increasingly important both in and out of Korea, the establishment of a European branch will greatly help us expand to overseas markets,” said Lee Young-jack, president of LSK Global PS, in a statement.

The global pharmacovigilance market has been growing as countries are increasingly becoming aware of the importance of ensuring the safety and efficacy of drugs and many emerging economies are receiving government support to open their own pharmacovigilance centers.

According to market tracker Zion Market Research, the global pharmacovigilance market is expected to grow from $3.87 billion in 2018 to $8.33 billion by 2025.

Korea joined the International Council on Harmonisation in November 2016 and has been imposing the council’s standards in manufacturing and conducting clinical trials for locally-produced pharmaceutical products.

LSK Global PS said it will continue working to expand its operations to regions outside Europe.

BY KO JUN-TAE [ko.juntae@joongang.co.kr]