CONTENTS -- 1. Introduction -- 2. General Policy -- 2.1 Cross-cutting pharmaceuticals - quality assurance issues -- 2.2 Pharmacopoeial Discussion Group -- 2.3 International Conference on Harmonisation -- 2.4 International Conference of Drug Regulatory Authorities -- 3. Quality control - specifications and tests -- 3.1 The International Pharmacopoeia (4th ed.) -- 3.2 New monographs for inclusion in The International Pharmacopoeia -- 3.3 Dissolution test requirements -- 3.4 Pharmacopoeial monographs on antiretrovirals -- 3.5 Specifications for antimalarials -- 3.6 Quality specifications for antituberculosis drugs -- 3.7 Specifications for other medicines -- 4. Quality control - International Reference Materials -- 4.1 International Chemical Reference Substances -- 4.2 Guidelines for chemical reference substances -- 5. Quality control - national laboratories -- 5.1 External Quality Assurance Assessment Scheme -- 6. Quality assurance - Good Manufacturing Practices -- 6.1 Biologicals -- 6.2 Sterile pharmaceutical products -- 6.3 New guidelines -- 7. Quality assurance - inspection -- 7.1 Training modules for inspectors -- 8. Quality assurance - distribution and trade related -- 8.1 Good distribution practices for pharmaceutical products -- 9. Quality assurance - risk analysis -- 9.1 New approach to inspections and manufacture -- 10. Quality assurance - Stability -- 11. Prequalification -- 11.1 Prequalification of priority medicines -- 11.2 Ongoing quality monitoring of prequalified medicines -- 11.3 Prequalification of quality control laboratories -- 11.4 Procedure for prequalification - manufacturers of active pharmaceutical ingredients -- 11.5 Guidance on variations to a prequalified dossier -- 12. Regulatory guidance -- 12.1 Medicines for children.

12.2 Revision/update of the guidance on the selection of comparator pharmaceutical products for equivalence assessment -- 12.3 Proposal to waive in vivo bioequivalence requirements for immediate release, solid oral dosage forms -- 12.4 WHO Certification scheme -- 13. Nomenclature and computerized systems -- 13.1 International Nonproprietary Names (INN) for pharmaceutical substances -- 13.2 WHO terminology used in quality assurance -- 14. Miscellaneous -- 14.1 Index of pharmacopoeias -- 14.2 Article on the Expert Committee -- 14.3 Promotional materials on quality -- 15. Summary and recommendations -- 15.1 New standards and guidelines adopted and recommended for use -- 15.2 Activities that should be pursued and progress reported at the next meeting of the Expert Committee -- 15.3 New areas of work suggested -- Acknowledgements -- Annex 1 -- The International Pharmacopoeia - related substances tests: dosage form monographs guidance notes -- Annex 2 -- List of available International Chemical Reference Substances and International Infrared Reference Spectra -- Annex 3 -- General guidelines for the establishment, maintenance and distribution of chemical reference substances. Revision -- Annex 4 -- Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies -- Annex 5 -- Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies -- Annex 6 -- Guidance on variations to a prequalified product dossier.