WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Close this folder2. General policy
View the document2.1 Specifications for medicinal plant materials and for herbal products
View the document2.2 Risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the document2.3 Stop TB programme
View the document2.4 Roll Back Malaria programme
View the document2.5 HIV/AIDS programme
View the document2.6 Future of The International Pharmacopoeia
View the document2.7 Pharmacopoeial Discussion Group (PDG)1
View the document2.8 International Conference on Harmonisation (ICH)
Open this folder and view contents3. Quality control - specifications and tests
View the document4. Quality control - international reference materials
Open this folder and view contents5. Quality control - national laboratories
Open this folder and view contents6. Quality assurance - good manufacturing practices
Open this folder and view contents7. Quality assurance - inspection
Open this folder and view contents8. Quality assurance - distribution and trade-related
Open this folder and view contents9. Quality assurance - risk analysis
Open this folder and view contents10. Quality assurance - drug supply
Open this folder and view contents11. Quality assurance - storage
View the document12. International Nonproprietary Names (INNs) programme
Open this folder and view contents13. Miscellaneous
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the documentAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Open this folder and view contentsAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
Open this folder and view contentsAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
View the documentAnnex 5 Model certificate of Good Manufacturing Practices
View the documentAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
View the documentAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Open this folder and view contentsAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover
 

2.8 International Conference on Harmonisation (ICH)

The Committee was provided with a draft document titled “Some considerations on the impact of ICH in non-member countries” and the Committee was informed that this document and its recommendations would be brought to the attention of the Tenth International Conference of Drug Regulatory Authorities to be held in Hong Kong Special Administrative Region of China in 2002.

The Committee considered that, while ICH standards were important in specifying requirements for pharmaceutical manufacturers of new chemical entities, WHO had an important role in adopting and adapting ICH standards for developing countries. The Committee therefore endorsed the need for WHO to intensify its efforts to develop international standards on the approval of generic products in consultation with the generic industry, related organizations and national authorities. This would improve access to quality essential drugs.

The Committee endorsed the general principles of the document.

 

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