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The Impact of Implementation of ICH Guidelines in Non-ICH Countries - Regulatory Support Series No. 009
(2002; 34 pages) View the PDF document
Table of Contents
View the documentExecutive Summary
View the document1. Introduction
View the document2. WHO'S role in developing global standards for pharmaceutical products
View the document3. The International Conference on Harmonisation (ICH)
View the document4. Expanded ICH initiatives
Open this folder and view contents5. Implications of the ICH process and globalization of ICH guidelines
Open this folder and view contents6. Implication of the use of ICH guidelines by non-ICH drug regulatory authorities
View the document7. WHO guidelines for generic drugs
View the document8. Challenges for WHO
View the document9. Recommendations to WHO
View the documentAnnex I - List of Participants

The Impact of Implementation of ICH Guidelines in Non-ICH Countries - Regulatory Support Series No. 009

Original: English
Distribution: General

Report of a WHO Meeting
Geneva, 13-15 September 2001

Regulatory Support Series, No. 9

This Series is produced by the WHO Drug Regulatory Support Unit and aims at providing guidance, assistance and training in drug regulatory issues.

The main focus is on supporting the work of national drug regulatory authorities of developing countries.

World Health Organization

© World Health Organization 2002

This document is not a formal publication of the World Health Organization (WHO).

All rights are reserved by WHO. The document may, however, be freely reviewed, abstracted, reproduced or translated, in part or in whole, but not for sale or use in conjunction with commercial purposes.

The views expressed in this document reflect the opinions expressed and the discussions that took place during the meeting. These views do not necessarily reflect the decisions or the stated policy of WHO.


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