Good Clinical Practices international guidelines

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic E6 Note for Guidance on Good Clinical Practice Consolidated Guideline, CPMP/ICH/135/95. London European Agency for the Evaluation of Medicinal Products, 1996. 

Food Drug Administration (PDA). International conference on harmonisation, good clinical practice consolidated guidelines. Federal Register 1997 62 25692-709. 

The Efficacy Committee of the International Conference on Harmonization has prepared a final guidance (E6) entitled Good Clinical Practice Consolidated Guideline. This document was issued by the FDA in April 1996, by both the Center for Drug Evaluation and Research and the Center for Biologies Evaluation and Research. This document should be consulted prior to completion of the final IB. 

The main regulative guidelines for pharmaceutical products date from 25 May 1972, updated 25 November 1999. Clinical tried regulations were introduced 18 November 1993 compliant with International Good Clinical Practice (GCP) Guidelines and came into force 1 January 1995. 

Guideline for Good Clinical Practice. International Conference on Harmonization [ICH] of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1996. http // www.ifpma.org/pdfifpma/e6.pdf. 

Organizacion Mondial de la Salud (International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use) Good Clinical Practice Consolidated Guideline. Documento no. E6GCPD12WP6. ICH Secretary. Ginebra, may 1996. 

International Conference on Harmonisation (1996) Guideline for good clinical practice. International Conference on Harmonisation, http //www.emea.europa.eu/pdfs/human/ich/ 013595en.pdf. 

International Conference on Harmonisation (ICH) (1996) E6(R1) Good Clinical Practice Consolidated Guideline, www.ich.org (accessed 9 August 2006). 

Source International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). http //www.ich.org/LOB/media/MEDIA482.pdf [accessed September 17,2007]. 

Guidelines for the conduct of clinical trials of pharmaceutical agents have been published (e.g., WHO, 1995), and internationally recognized EC Principles of Good Clinical Practice have been developed (EC,... 

U.S. Department of Health and Human Services, Food and Drug Administration, Fed Reg. International Conference on Harmonization, Draft Guideline on Good Clinical Practice, 60 (159) 42947-42957, Aug. 17,1995. 

Investigator s Brochure Conformity with the International Conference on Harmonization Good Clinical Practice Guideline for the... 

Principles for the conduct of clinical research are set forth in internationally recognized documents, such as the Declaration of Helsinki and the Guideline for Good Clinical Practice of the International Conference on Harmonization (ICH) [14]. 

According to the International Committee on Harmonization and Good Clinical Practice guidelines (ICH/GCP), in the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic... 

There are a number of Western publications, as well as materials from various conferences (Droujinine 1996 Loran et al. 1996 Sinackevich 1997), that address clinical trials in Russia. It is important to mention the appearance of the new Instructions. .. as well as adopting the International Conference on Harmonization Good Clinical Practice (ICH GCP) as the major guidelines for conducting clinical trials by the Russian MOH (12 August 1997). 

Note the acronym CRO is used throughout this document to refer not only to a contract research organization (CRO), but also to any organization involved in the conduct or analysis of in vivo bioequivalence studies. As defined in the International Conference on Harmonisation (ICH) Tripartite Harmonised Guidelines, Guidelines for Good Clinical Practice (5), a CRO is a person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor s trial-related duties and functions. 

International Conference on Harmonisation (ICH) Guidelines. Tripartite Harmonized Guidelines for Good Clinical Practice, Step 4. Geneva, ICH Secretariat (IFPMA), 1996. 

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