The government has suspended Il-yang Pharmaceutical’s manufacturing of Teratect Prefilled Syringe Inj., a quadrivalent influenza vaccine, for one month from July 27 due to the company’s failure to submit data for a drug reassessment.
|Teratect Prefilled Syringe Inj. (Credit: Il-yang Pharm)|
Suppliers of novel drugs or medicines designated by food and drug safety minister must conduct safety and efficacy studies for six or four years after winning approval and apply for the regulator’s reevaluation within three months. If the company fails to submit necessary data within the period, it has to face administrative punishment.
Il-yang obtained the nod for Teratect on Sept. 9, 2016. It was the second licensed flu vaccine to be produced from fertilized eggs in Korea.
In May, Il-yang obtained the World Health Organization’s prequalification (PQ) for Teratect, being eligible to participate in international biddings hosted by WHO’s units and to supply products. Through PQ, the WHO certifies the safety and efficacy of a vaccine, as well as the manufacturing process, quality of the vaccine, and clinical results.
The latest suspension is expected to hurt Il-yang’s vaccine supply and international biddings in the second half.