WHO Expert Committee on Specifications for Pharmaceutical Preparations: forty-sixth report: 970

The following new guidelines were adopted and are included in the report: development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products; Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Program: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements when artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients.

In addition, 18 new monographs and general test methods were adopted for inclusion in The International Pharmacopoeia. The specifications under development are internationally applicable methods for testing antimalarial, antituberculosis, antiretroviral and radiopharmaceutical medicines, as well as medicines for children.