Japanese Regulations of RM Products

GCTP Ministerial Ordinance
　Japanese GCTP (Good Gene, Cellular and Tissue-based Products Manufacturing Practice) for themanufacturing
　management and the quality control of regenerative medicine products was enforced as theminister ordinance
　on 12th August 2014.

• • • 　<Main Items on J-GCTP>
      
      
      • Marketing Authorization Holder (MAH) (Article 3)
        　 Japanese MAH and designed foreign MAH shall have manufactures, etc. established the system on manufacturing
        　 management and quality control as a requirement of manufacturing and marketing approval based on GCTP regulation.
      • Manufacturing Division and Quality Division (Article 5)
        　 The manufactures, etc. which must indicate the manufacturing manager beforehand need to have a manufacturing
        　 division and a quality control division under the control of the manager in each factory. There must be quality control
        　 division independently of the manufacturing division.
      • Quality Standard Code (Article 8)
        　- Regulated to create, storage and handle in every product and every manufacturing site
        　- Included the standard for biological ingredients, the matter on the quality when receiving an improvement order and
        　　the quality matter as regulatory approval condition
        　- Included origin, producing place and the methods of manufacture management and quality control to secure the
        　　ingredient quality
      • SOP (Article 9)
        　 Manufactures shall set the following SOPs in every factory;
        　The sanitation control standard code, the manufacturing control standard code and the quality control standard code
      • The structure facilities of factory (Article 10)
      • The manufacture management (Article 6)
      • The quality control (Article 12)
      • The management of shipment from a factory (Article 13)
      • Handling of the information on quality and quality failure (Article 15)
      • Validation or verification (Article 14)
      • Procedure for handling of recall (Article 19)
      • Procedure for self-inspection (Article 21)
      • Training (Article 21)
      • Document and record control (Article 22)
      • <Other Japanese Regulations on Regenerative Medicine Product, etc.>
        
      • The standard for GCP ministerial ordinance (PFSB Notification 0812 No.23 dated on Aug. 12, 2014)
      • The non-clinical studies which should be conforming to GLP (PFSB Notification 0812 No.20 dated on Aug. 12, 2014)
      • Documents which should be attached when submission file for a manufacture and sales approval
        　(PFSB/ELD/OMDE and Minister's Secretariat/Councilor Notification 0812 No.5 dated on Aug. 12, 2014)
      • The standard for raw materials of biotechnical/biological products
        　(PFSB/ELD/OMDE and the Minister's Secretarial/Councilor Notification 1002 No.1 dated on Oct. 02, 2014)
      • About the report system of infection disease (PFSB Nitification 0812 No.7 dated on Aug. 12, 2014)
      • The standard for post marketing surveillance and clinical trials (GPSP)
        　(PFSB Notification 0812 No.23 dated Aug. 12, 2014)
      • Handling of combination products (regenerative medicine product and medical device)
        　(PFSB/ELD/OMDE and the Minister's Secretariat/Councilor Notification 1024 No.1)
      • GVP standard (Ministerial Ordinance No.44 dated on Jul. 30, 2015)
      • GQP standard (Ministerial Ordinance No.87 dated on 30, 2015)
      • <Abbreviation of MHLW Organization>
      • 　　PFSB: Pharmaceutical and Food Safety Bureau, ELD: Evaluation and Licensing Division
      • 　　OMDE: Office of Medical Devices Evaluation