In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Trabectedin Drug Master File in Korea (Trabectedin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trabectedin. The MFDS reviews the Trabectedin KDMF as part of the drug registration process and uses the information provided in the Trabectedin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trabectedin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Trabectedin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trabectedin suppliers with KDMF on PharmaCompass.