K-Bio Heading to Indonesia, MFDS Also Steps Up Support

The Ministry of Food and Drug Safety (MFDS) announced on the 26th that it will visit Indonesia from the 25th to the 29th to hold a director-level bilateral cooperation meeting with the Indonesian Food and Drug Authority to strengthen cooperation in the quality management of plasma fractionation products and support the export of domestically produced biopharmaceuticals to Indonesia.

[Image source=Yonhap News]

At this meeting, the MFDS and the Indonesian Food and Drug Authority plan to discuss cooperation measures regarding the import of raw plasma, blood product approvals, manufacturing and quality control, and national batch release approvals. This was arranged to secure a stable supply of raw plasma while supporting the export of domestic plasma fractionation products, as domestic plasma fractionation manufacturers are now able to establish blood product factories locally in Indonesia.

Recently, GC Green Cross and SK Plasma have been accelerating preparations to build blood product plants in Indonesia. GC Green Cross received final approval for the related business license from the Indonesian Ministry of Health and Welfare on the 1st and subsequently signed a business agreement with the Indonesian Red Cross and local pharmaceutical company P.T Triman on the 14th. SK Plasma is also proceeding with the export of a blood product plant together with Daewoong Infion, a local joint venture of Daewoong Pharmaceutical in Indonesia. Construction began last month, with completion targeted for 2025. The facility is planned to be capable of processing 1 million liters of raw plasma annually.

GC Green Cross announced on the 15th that it has signed a plasma supply business agreement for blood product processing and plant business with the Indonesian Red Cross and pharmaceutical company Triman. James Triman, CEO of Triman Pharmaceutical, Yusuf Kala, President of the Indonesian Red Cross, and Yoon Young-jun, Head of Global Business Unit at GC Green Cross (from left).
[Photo by GC Green Cross]

Additionally, the MFDS plans to visit local biopharmaceutical manufacturing plants established by Korean pharmaceutical companies in Indonesia to listen to the regulatory challenges faced by Korean companies and continue consultations with the Indonesian Food and Drug Authority to resolve regulatory issues related to biopharmaceuticals. Currently, in addition to Daewoong Infion, pharmaceutical plants established through cooperation between local pharmaceutical companies and Korean companies such as CKD-OTTO of Chong Kun Dang and PT Combiphar Dong-A Indonesia of Dong-A ST are operating locally in Indonesia.

Furthermore, the MFDS will attend the ‘Quality Control and Testing of Blood Products’ workshop held in Jakarta, Indonesia, on the 26th and 27th, hosted by the World Health Organization (WHO), where it will present Korea’s blood product quality management policies to ASEAN biopharmaceutical regulatory experts. This presentation was made at the request of the WHO and is expected to demonstrate the MFDS’s internationally recognized regulatory capabilities while serving as an opportunity to export excellent domestic biopharmaceuticals to ASEAN countries.

Shin Jun-su, Director of the MFDS Bio and Drug Division, said, “The establishment of local blood product factories in Indonesia by domestic pharmaceutical companies is the result of Korea’s internationally recognized excellence in biopharmaceutical manufacturing and quality management.” He added, “We will strive to open new paths so that excellent domestic products can be smoothly exported by advancing as a leading country in biopharmaceutical regulatory science.” He also stated, “We hope this cooperation meeting will serve as an opportunity to raise the regulatory standards for the safe management of plasma fractionation products and greatly benefit the national interests of both countries.”

This content was produced with the assistance of AI translation services.