The MFDS (Minister: Chung, Seung) announced that starting in 2015, the scope of custom counselling and field advice services will be expanded for domestic vaccine manufacturers wishing to have their products to be PQ certified.

PQ refers to pre-qualification and under this mechanism, the WHO evaluates the quality, safety, and efficacy as well as safety control capacity of the national regulatory agency of a country from which the vaccine manufacturer concerned originates.

The extensive custom and field counselling services are expected to help improve international standing of Korea-manufactured vaccines, and have a leg up on the international vaccine procurement market.

Support details are: PQ document authoring techniques in areas including clinical studies and quality review; relevant information and cases regarding the WHO GMP inspection designing and attachment instructions related to vaccine vial monitoring (VVM) labelling.

The services include the provision of tailored counselling and mock inspection as well as how to create PQ documents with what contents.

The VVM allows to confirm vaccine storage conditions by checking the color changes of labels with accumulated temperatures, and VVM is required by UNICEF and other international organizations for vaccines that are distributed to many African countries and others with a tropical climate.

For reference, Korea's vaccine export volume was roughly USD 200 million in 2013, and of this, the WHO PQ exports took account 95% (USD 190 million), which compare to 47% of the entire biologics exports (USD 400 million).

The first PQ product approved was Euvax B Injection (1996) and by the end of 2014, 14 vaccine products were PQ certified, and of the total 230 WHO PQ-certified vaccines, 6.1% was manufactured in Korea.

Particularly, the WHO granted Quinvaxem cPAD a PQ certification in just eight months by sharing data of inspection conducted by the MFDS without any inspections carried out by the WHO.

The MFDS expects that the expanded tailored services and field counselling will reduce time taken to process for the WHO PQ certification, and secure a beachhead in the international market by Korean vaccine manufacturers. Furthermore, the national agency vowed to continue to help the industry improve export competitiveness by lending support in a more proactive manner.

Jan, 15, 2015, Press Release by the MFDS,