Pharmaceutical company and (Drug) Master File in …

1 Pharmaceutical company andand ( drug ) Master File in JapanThe Second China - Japan SymposiumApril 29th2011, BeijingMr. Yoichi TAKASHITAAsia SubcommitteeInternational Affairs Committee, JPMA (Senju Pharmaceutical Co., Ltd.) 1 Contents of MF(1)Flow(1)Flow(2)Items for MF registration(3)Application form(3) pp ca oo(4)Attached documents(5)Reception Deskp(6)In-country Marketing Authorization Holder(1)Required documentation(2)Ministerial Ordinance No. 136 (GQP)()(3)Obligations of Marketing Authorization Holders(4)Report for changing(5)T k2(5)Task1 Outline of of Marketing Authorization Holder3 Flow of Regulatory Review of MFsM k tiA th i tiApplication step Marketing Authorization Holders(Applicant) PMDA MHLW MF registration MF registrationMF PMDA notify the applicantof the inquiry aboutMFs step Inquiry of the inquiry aboutMFsMF in-country caretaker step andInspection / in-country caretaker / MF Registrant 4g(step 0 or 1) accreditationAccredited Foreign Manufacturer Items for MF registration drug substances intermediates drug substances, intermediates, Pharmaceutical product materials New excipients , new pre-mix excipients pre-mix Materials for medical devices.

2 Ctikgig til Containers, packaging materials. etc application form6 Documents required : Application form , supporting dataItems for an approval application form 1/3 Classification of Registration( Type of Substances, etc. ) Name of drug substances, etc. Name of manufacturing site and other information Information about ingredients and their quantity or nature of drug substances, etc. Manufacturing method, manufacturing process control and quality control testcontrol, and quality control test 7 Items for an approval application form 2/3 Specifications and test methods St bilit t ttth ddid t Stability tests, storage method, and expiry date Storage Method and Expiry Date Information on safety 8 Items for an approval application form 3/310 Category of license for manufacturing operation or dit tif fif taccreditation of foreign manufacturer 11 Number of license for manufacturing operation or number and date of accreditation of foreign fmanufacturer 12 Name and address of in-country caretaker if the applicant for the MF registration is manufacturing ppggdrug substances, etc.

3 Outside Japan 9 Attached documentsAttached documents for an approval application form Data on Manufacturing Methods and Specifications/Test Methods Data on Stability Data on Pharmacological Action etc send CTD format for attached documentsPlease send CTD format for attached documentsto the in-country caretaker. CTD 10 Open part and Closed part of MF 1/4 , system provides for Disclosed and Non-Disclosedfor Disclosed and NonDisclosed Informationon 11 Open part and Closed part of MF 2/412 Open part and Closed part of MF 3/413 Open part and Closed part of MF 4/414 Reception Desk/ / Reception Desk/ / Pharmaceuticals and Medical Devices Agency (PMDA)Review Operation DivisionShin-Kasumigaseki Building 6th floor,3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan 100-0013 3 3 2 TEL : 03-3506-9437 FAX : 03-3506-9442 Office hours 9:30 12:00 and 13:30 17.

4 0015in-country caretaker Non qualification Non qualification Address in Japan Abilit fthi t tili ti Ability for the registration application and the registration management Japanese language power Japanese language power Knowledge of Pharmaceutical Affairs Act of chemistry in Japan 16 17 18 The published information for MFNumber 222MF10232 Date: 22 9 19 19 Name of Holder Synbiotics Address ..India Name of product 1 Outline of of Marketing Authorization Holder20 Required documentationqMarketing Authorization Holder drug Manufacturer need : The copy of MF registration MF e copy oeg s a o MF The agreement with MF registrant(ft)dDft(raw manufacturer) and drug manufacturerMF ( ) 21 Ministerial Ordinance No. 136 / 136 / 136 ( Article 7(3) The nature and extent of the periodical verification, by the marketing authorisation holder, of the manufacturing dutiesmarketing authorisation holder, of the manufacturing dutiesthat they are conducted under the proper and efficient manufacturing control and quality control,22 Ministerial Ordinance No.)

5 136 / 136 ( / 136 ( Atil 10 Article 10(1) To periodically verify that the manufacturing control and quality control by the manufacturers, etc. is conducted properly and efficiently in accordance with the standards and items specified inefficiently in accordance with the standards and items specified in MHLW Ministerial Ordinances that are provide to by established under the provision of Item (4) of Paragraph 2 of Article 14 and Paragraph 2 of Article 18 of Law and ingpaccordance with the contract specified in Article 7 of this Ministerial Ordinance, and to establish records regarding the results of the verification, and23 Obligation of Marketing Authorization HoldersObligation of Marketing Authorization Holders Marketing Authorization Holders has the gsame guarantee responsibility as its company asfor the product of raw materials fhliibilimanufacturer on the quality responsibility.))

6 24 Report of change & deviate information MF registrant must notify each applicant of the detailed information registered in MF or evenanydetailed information registered in MF or even anychangesand deviations made to their registered items in advance. MF MF FM If any changes are made, it should be properly discussed whether those will affect the quality of Pharmaceutical products or not to assure productpharmaceutical products or not to assure product safety, among MF registrant, applicants or marketing approval holders who quote the MF. (In order to avoid troubles)troubles) MF MF 25 lil30 25lil30 I am terribly sorry that I do not understant the English here and therefore I am not able to correct , 2011-3-9 Task Task drug manufacturer must visit raw mfg.

7 Site regularly, and maintain the environment that can exchangeand maintain the environment that can exchange information is necessary. 26 MF DMF The MF system of Japan is not as same as Europe and US DMF systemsame as Europe and US DMF system. MF DMF 27 Thank you for your 2005 4 former current GMP GVP, GQP GMP 29 Relation between and GQP GVP GQP GVP inspection 30