MF—drug中英文.doc

Master File System for Drug Substances, etc 1. Master File (MF) System Master file (hereinafter referred to as “MF”) system for drug substances, etc. allows Japanese or foreign manufacturers of drug substances etc. to voluntarily register the data concerning the quality/manufacturing methods of their drug substances, etc. used for manufacture of drugs (pharmaceutical products) to the review authority. The registered data is quoted as the necessary information for an approval review of the drug (pharmaceutical product) in which the drug substance is used. Japanese or foreign drug manufacturers can register in MF by submitting the specified forms (application form for MF registration, application for change in registered items, minor change notification, etc.) to Pharmaceuticals and Medical Devices Agency (hereinafter referred to as “PMDA”) in accordance with the procedures described in the Enforcement Regulations for the Pharmaceutical Affairs Law (hereinafter referred to as “Regulations”). (See Article 72, 79, and 81 of the Regulations (*1); “Documents to be Submitted”.) Foreign manufacturers of drug substances, etc. can also apply for MF registration. In order to apply for MF registration, it is necessary for a foreign manufacturer to obtain a foreign manufacturer accreditation (*2) because the accreditation category, the accreditation number, and the date of accreditation of the foreign manufacturing site must be entered in the MF registration application form. In addition, when a foreign manufacturer applies for the accreditation and MF registration, the manufacturer codes for the foreign manufacturer and for the manufacturing site are required. Thus the both codes must be registered in advance. When a foreign manufacturer applies for MF registration, a person to undertake the duties concerning the relevant MF registration with an address within Japan (in-country caretaker of drug substances) shall be appointed (Article 72 of the Regulations). MF registration app