Domestic Production of Radioactive Raw Material Pharmaceuticals 'Green Light'... Nuclear Research Institute Obtains MFDS Product Approval

A green light has been turned on for the localization of radioactive raw material pharmaceuticals, which had relied entirely on imports.

The Korea Atomic Energy Research Institute (KAERI) announced on the 11th that the radioactive raw material pharmaceutical "KAERI Sodium Iodide (hereinafter I-131) solution" produced at the research reactor Hanaro has received product approval from the Ministry of Food and Drug Safety (MFDS) for the first time in Korea.

‘KAERI Sodium Iodide (I-131) Solution’ Prototype. Provided by Korea Atomic Energy Research Institute

Dr. So-Young Lee's research team at the Isotope Research Division of KAERI established procedures, methods, equipment, and facilities applying GMP standards throughout the entire commercialization process of the I-131 solution produced at Hanaro, and applied for product approval from the MFDS last year, ultimately receiving the approval.

I-131 is mainly used as a raw material for radioactive pharmaceuticals for the treatment of intractable cancers. However, until now, there has been no product in Korea that meets the Good Manufacturing Practice (GMP) standards, so the country has relied entirely on imports.

Unlike radioactive pharmaceuticals, radioactive raw material pharmaceuticals have not been subject to mandatory GMP application, so there had been no cases of approval from the MFDS in Korea. For the same reason, domestic pharmaceutical companies and hospitals had no choice but to import GMP-applied I-131 at high prices from overseas.

However, with KAERI receiving product approval for GMP-applied I-131, the path to producing domestic products has opened.

In particular, the approved production volume of I-131 at Hanaro is 2,000 curies (Ci) per year, which exceeds the total domestic I-131 usage (1,537 curies as of 2020), and is expected to meet all domestic demand.

Additionally, it complies with international standards such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines for pharmaceutical quality, clinical and non-clinical data formats in the International Council for Harmonisation Common Technical Document (CTD), and quality control according to the European Pharmacopoeia, making future exports possible.

Interior view of the hot cell for manufacturing 'KAERI Sodium Iodide (I-131) solution'. Provided by Korea Atomic Energy Research Institute

Radioactive raw material pharmaceuticals are radioactive active substances containing radioactive isotopes and are used as raw materials for radioactive finished pharmaceuticals.

The main application of I-131 is as a raw material for radioactive pharmaceuticals used in the treatment of intractable cancers. I-131 is also used as the main raw material for "Iodine-131 mIBG (I-131 mIBG)," a radioactive pharmaceutical produced and supplied solely by KAERI in Korea for the treatment of rare pediatric cancers such as neuroblastoma.

Jung Young-wook, Director of the Hanaro Quantum Science Research Institute, said, "By stably supplying high-quality radioactive pharmaceutical raw materials, we can expect the revitalization of the domestic radioactive pharmaceutical industry," adding, "KAERI will also put more weight on exporting various radioactive raw materials and radioactive pharmaceuticals in the future."

Meanwhile, this achievement is the result of research conducted over the past three years with support from the Ministry of Science and ICT's "Development of Standardization Technology for Radioisotope Applications" project.

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