Updated on 27 January 2015
LG Life Sciences' hepatitis B vaccine "Euvax B," became the first Korean product to earn PQ qualification
Singapore: The Korean Ministry of Food and Drug Safety (MFDS) recently announced plans to support and nurture domestic vaccine manufacturers, by helping them obtain WHO's pre-qualification certificate, which will help in increasing vaccine exports.
The agency announced that it would expand its WHO PQ counselling and consulting for Korean manufacturers who wish to obtain the certification. The PQ (prequalification) program aims to comprehensively evaluate the quality, safety and efficacy of medicinal products in close cooperation with national regulatory agencies and partner organizations, in order to provide the products to developing countries. As the PQ qualification guarantees the safety of the vaccines, it can raise product credibility in the global market.
The MFDS proposes to help Korean vaccine manufacturers by providing details about PQ documentation to be submitted to the WHO for clinical tests and quality inspections, information about the WHO's inspection standards, and how to produce and place VVM labels.
The agency will also offer mock inspections and customized counselling to the domestic vaccine makers. An official at the ministry said to a news daily, "To improve brand awareness of Korean vaccines and to increase international procurement, we set up the plan and will offer other services to raise the competitiveness of domestic pharmaceuticals in the global market."
So far, 14 Korean vaccines have obtained the PQ qualification, including LG Life Sciences' hepatitis B vaccine "Euvax B," which in 1996 became the first Korean product to earn PQ qualification.