GLP/GCP: Requirement and implementation (Japan) Takashi Kozasa DVM Ministry of Agriculture, Forestry and Fisheries Government of Japan 1 5 th VICH Outreach Forum meeting (February 25, 2015)
Legal Cascade for VMPs in Japan Biological products standard National-Assay standard, etc. Regulatory rules specific to VMPs (GLP, GCP, GMP, etc.) Legally-binding Top legislation for medicinal products in Japan Applicable for both MPs and VMPs The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, etc. MAFF Ministerial Ordinances MAFF Ministerial Announcements from MAFF-HQ Director General or Director from NVAL Director General (including GUIDELINEs) non-binding Notice 2
1. Good Laboratory Practice (GLP) [Article 14(3)] of the Act A person intending to obtain an approval pursuant to Paragraph 1 shall attach documents on the results of clinical studies or any other pertinent data to the application, in accordance with MAFF Ministerial Ordinance. Ministerial Ordinance on the GLP Standard for the Conduct of Non-Clinical Safety Studies of Veterinary Medical Products (Ordinance No.74 of 1997) Applied to safety studies, toxicity studies and residue studies on the products intending to use in bovine, equine, swine, chicken, quail, honeybee and aquaculture animals for food Applied to safety studies and toxicity studies on the products intending to use in dogs and cats 3
Implementation of GLP in Japan Notice on “Standards for the Conduct of Animal Studies of Veterinary Medical Products” was published in 1987 Applicants were required to submit the dossier with data on safety studies, toxicity studies and residue studies (except companion animals) on the products intending to use in food-producing animals, dogs and cats conducted in accordance with the notice since 1988 MAFF Ministerial Ordinance (GLP Ordinance) was published in 1997 (effective since 1999) The OECD GLP Working Group confirmed that Japanese GLP of VMPs meets the OECD GLP principle in 2013 after the on-site evaluation visits 4
GLP Ordinance Purpose (Article 1) Definitions (Article 2) Practices for Conduct of Study (Article 3) Responsibilities of the Sponsor (Article 4) Chapter 1 General Provisions Personnel (Article 5) Test Facility Management (Article 6) Study Director (Article 7) Quality Assurance Unit (Article 8) Chapter 2 Personnel and Organization 5
GLP Ordinance Test Facility (Article 9) Equipment (Article 10) Chapter 3 Test Facility and Equipment Standard Operating Procedures (Article 11) Animal Care and Management (Article 12) Chapter 4 Operation at Test Facility 6
GLP Ordinance Handling Test Items and Reference Items (Article 13) Reagents and Solutions (Article 14) Chapter 5 Handling of Test Item, etc. Study Plan (Article 15) Conduct of the Study (Article 16) Chapter 6 Study Plan and Conduct of Study 7
GLP Ordinance Final Report (Article 17) Storage of Study-related Materials (Article 18) Chapter 7 Report and Storage Compliance matters (Article 19) Chapter 8 Multi-site Study 8
2. Good Clinical Practice (GCP) [Article 14(3)] of the Act A person intending to obtain an approval pursuant to Paragraph 1 shall attach documents on the results of clinical studies or any other pertinent data to the application, in accordance with MAFF Ministerial Ordinance. [Article 80-2] of the Act A person intending to sponsor a clinical trial shall assure that such sponsored trial is conducted in accordance with the standards specified in MAFF Ministerial Ordinance. Ministerial Ordinance on the GCP Standard for the Conduct of Clinical Studies of Veterinary Medicinal Products (Ordinance No.75 of 1997) Applied to clinical studies on the products intending to use in bovine, equine, swine, chicken, dogs and cats 9
Implementation of GCP in Japan Notice concerning “Standards for the Conduct of Clinical Studies of Veterinary Medicinal Products” was published in 1996 MAFF Ministerial Ordinance (GCP Ordinance) was published in 1997 (effective since 1999) The Ordinance is compliant with VICH GL9 (GCP) implemented in
Thank you for your attention 11