On January 15, the MFDS announced that it would expand its WHO PQ qualification counseling and consulting for Korean vaccine manufacturers who want to receive 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.
As of 2013, among the total US$200 million volume of vaccine exports, the majority ($190 million or 95%) were exported through the PQ qualification.
To help Korean pharmaceuticals earn the qualification, the MFDS provides know how on passing the test, such as PQ documentation 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.
In addition, for the WHO PQ inspections, the ministry will offer customized counselling or mock inspection, along with help in providing required inspection information in the documents for submission.
An official at the ministry said, “To improve brand awareness of Korean vaccines and to increase international procurements, we set up the plan and will offer other services to raise the competitiveness of domestic pharmaceuticals in the global market.”
Meanwhile, as of 2014, 14 items had 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.
By John Choi (firstname.lastname@example.org)