MVC's aseptic filling line of enterovirus EV71 (EV71) vaccine obtained TFDA's PIC/S GMP approval. After combining previous PIC/S GMP approval of EV71's bulk production granted on November 29th, 2018, MVC's certification number is updated to (IMP)0460020. Since MVC's entire EV71 vaccine production line, from bulk production, fill/finish to laboratory, now fulfills stringent PIC/S GMP requirement, MVC is able to speed up supplying EV71 vaccines to South East Asia due to the mutual recognition agreement among ASEAN countries.
MVC's production plant is located in Zhubei Biomedical Park and is Taiwan's first PIC/S GMP level cell-culture vaccine production plant. Zhubei plant is designed to have integral manufacturing functions including bulk production, aseptic filling and finishing. Benefitting from PIC/S GMP certification and experience, MVC is able to develop more high-quality products and offer CDMO services.
PIC/S stands for International Pharmaceutical Inspection and Consultation Organization, which is the most stringent pharmaceutical quality management standard in the world. PIC/S members can mutually recognize each other's certifications to reduce oversea inspections and to speed up people's access to new medicines. By far 9 ASEAN countries have mutually recognized TFDA's PIC/S GMP certification.