(1) Reasons for Proposal
This request has been made to promote the rational operation of the Drug Master File (DMF) system by limiting the use of the injections subject to DMF to medical purposes; and by temporarily excluding pharmaceutical preparations used for supplying their main ingredients as nutrition from the list subject to DMF until such system is stabilized.
(2) Major Provisions
A. Allow a manufacturing certificate for import products to be submitted on an optional basis, which has been compulsory, when applying for Drug Master File (Article 4)
B. Exclude the medicines for the shortage-preventive drugs and for supplying nutrients, among drug substances from Drug Master File (attached Table 1)
C. Amend the previous addendum (Addendum Article 4 of the Notice of Ministry of Food and Drug Safety No. 2016-59) to the effect that the drug substances used to manufacture permitted injections (antibiotic substance preparations) may also be designated as a medicine for Drug Master File
(3) Amendment Details
The Regulations on Drug Master File is partially amended as follows.
The proviso to Article 4 (1) 2 (a) of the regulation shall be deleted and the following shall be newly inserted as follows.
B. For import products, a manufacturing certificate corresponding to Article 4 (1) 4 (a) of the Regulation of Medicinal Product Safety may be submitted in lieu of the documents under (a).
No. 210 in the attached Table 1 shall be as follows.
210. Drug substances of injections. Provided that the drug substances of the medicines for supplying components and nutrients corresponding to the shortage-preventive drugs designated by the Minister of Health and Welfare under the Article 13 (4) 7 of the Regulation for Criteria for Providing Reimbursed Services are excluded.
Article 4 of the Addendum of the Regulations on Drug Master File of the Notice of Ministry of Food and Drug Safety No. 2016-59 (June 30, 2016) shall be newly inserted as follows.
Article 4 (Transitional measures on Drug Master File for injections) Despite Article 3, any person who has obtained approval to manufacture and sell or import - including a notification - products corresponding to the antibiotic substance preparations (drug effect code 610) shall comply with the amended provisions of the attached Table 1 until January 1, 2020.
Addenda
Article 1 (Enforcement Date) This notice shall enter into force from the date of notification.
Article 2 (Applicability) The revised regulations may also be applied when the application for Drug Master File (including changes) has been submitted to the Minister of Food and Drug Safety in accordance with the previous provisions at the time of enforcement of this notice.
