• US:  www.fda.gov

# US FDA 21 CFR

* part 11: electronic records, electronic signature

* part 50: protect of human subjects

* part 54: financial disclosure by clinical investigators

* part 56: IRB

* part 312: investigational new drug application

# Guidelines

* FDA PI oversight

# Guidance for Industry

* Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects  Oct/2009

 

• EMA: http://eur-lex.europa.eu

                   http://ec.europa.eu

# EMA Directives

* DIRECTIVE 2001/20/ EC, 04-April- 2001

* DIRECTIVE 2005/28/ EC, 08-April- 2005

* DIRECTIVE 2001/83/EC, 6 November 2001            

 

 

• ICH: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

# ICH Guidelines:                                                                                                                         

* ICH E6 (R1) Guideline for good clinical practice/ 10 June 1996

* ICH E3 Structure and content of clinical study reports/ 30 November 1995       

    

                                                                                                         

• CFDA: http://www.sda.gov.cn

* Drug Administration Law of the People's Republic of China - Order of the President of the People's Republic of China - effective on Dec 1, 2001

* Regulations for Implementation of the Drug Administration Law of the People's Republic of China - Decree of the State Council of the People’s Republic of

* China No. 360 - effective on Sep 15, 2002

* China Good Clinical Practice - State Food and Drug Administration (SFDA) Regulations No. 3 - effective on Sep 01, 2003

* Provisions for Drug Registration - SFDA Regulations No. 28 - effective on Oct1, 2007

* Law on Licensed Doctors of the People's Republic of China - effective on May1, 1999