Introduce GLP GCP into China Shixin XU Ph D

Introduce GLP/GCP into China Shixin XU, Ph. D, Prof. China IVDC

I. III. IV. 2 The Benefits of GLP/GCP Main contents of GLP/GCP Progress of GLP/GCP Target of GLP/GCP

I. VICH The Benefits of GLP/GCP 3

Benefits • to avoid the waste on repeated study in the development of veterinary drug • ensure the conduct of test (genuine) • improve the quality of data (integrity) • ensure the validity of test data (reliability) 4

Benefits • prevent the application dossier may have the following problem: üstudy protocol is irrational ütest animal standards are not fulfilled üanimal facilities do not fulfill the requirement ü test results are inexplicable ü operation procedures are not normative ü false data-veracity 5

II. VICH Main contents of GLP/GCP 6

Main Contents • GLP in China ü 8 chapters, 48 articles, including a) b) Institutions and personnel c) Test facilities d) Instruments and materials e) SOPs f) Enforcement of test g) Archives h) 7 General rules Annex

Main Contents • GLP applicable to non-clinical studies related to acute toxicity, subchronic toxicity, reproductive toxicity(teratology study), chronic toxicity (carcinogenic test), and immunogenic test, local toxicity and irritation test, toxicokinetics, etc. , other test available for the safety assessment within laboratory. • Similar to human medicine GLP, or OECD GLP guidelines. 8

Main Contents • GCP in China ü 14 chapters, 74 articles, including h) Data management and statistical analysis i) Enforcement of test a) b) Institutions and personnel c) Sponsor d) Monitor k) Animal Selection and management e) Preparation and requirement l) Quality assurance and control f) Test Protocol m) Multicenter test g) 9 General rules Records and report n) Annex j) Administration on investigational drug

Main Contents • GCP applicable to clinical studies related to various systemic studies on target animals. • Similar to VICH GCP guidelines. • only frame of the guidelines was modified, ideas are embodied in Chinese GCP. Responsibility of investigator, sponsor and monitor, documentation and report, animal welfare and disposal are stipulated. 10

Main Contents • Institutions for clinical trials üSeems to be third independent institution ümandatory to be juridical institution, have the required laboratory and animal farm related to test titles conducted, the animal facilities and equipment and laboratory instrument could meet the requirement to safely and effectively conduct the clinical study. 11

Main Contents • certificate and compliance • The institution can voluntarily apply for certification, but will accept regular and irregular audit. • to be based on the animal species, test titles and type of drug (medicine, vaccine, herb medicine). i. e. , ü Pharmacokinetics of medicine in pigs üClinical trials of antiparasitics in cattle 12

Main Contents • considerations ü different test titles, need different test instrument ü different animal species, need different animal facilities, husbandry management and environment ü clinical trials may be termed as artificial infectious animal and natural infectious animal. 13

III. VICH Progress of GLP/GCP 14

Progress • Currently, GLP/GCP guidelines have not yet been officially issued, but public comments in China have been finished, many company including foreign industry had presented their comments to MOA. • It is estimated to be issued in 2015, and will be enforced in the year. 15

Progress • The equivalence between laboratory accreditation system or metric accreditation and GLP/GCP? • Professional personnel and animal facilities may be more important in GLP/GCP • Standard Operation Procedures for animal test need to established • Animal facilities need to be improved further 16

Progress • Several Challenges üthe institution has not yet handled the GLP/GCP guidelines, including our IVDC, though we participating the discussion of the draft. üThe team of accreditation and compliance has not yet been setup, and members of the team need to be trained and further to study the official guideline. 17

IV. VICH The target 18

Target • GLP ü From the point of view on toxicology evaluation for veterinary medicines, GLP laboratory from human drugs can be accepted directly. ü There are 43 labs for human drugs have been certificated including labs from the third independent labs, regulatory labs and industry labs. ü Several tests like PK, BE, residue depletion may follow both GLP and GCP. ü For veterinary drugs, 10 GLP Labs may be expected 19

Target • GCP üThe most needed guidelines for clinical trials üThe more labs, the better, sponsor can have more selection right. 20

Target • Industry labs certificate üThe labs from industry may have same rights as the third independent labs. üIndustry labs can provide test results only for its own application of registration for products. üForeign industry will be equal treated as internal industry, no discrimination. 21

China MOA public website http: //www. moa. gov. cn China IVDC public website http: //www. ivdc. gov. cn http: //www. ivdc. org. cn 22 22

Thank you for your attention! 23