Guidelines for the Compilation of a Product Dossier for Submission in the Assessment Procedure for New and Multi-Source (Generic) Products Used in the Treatment of Malaria: Section 5. Efficacy and safety: Section 5.3 Summary of pharmacology, toxicology and efficacy of the product

Guidelines for the Compilation of a Product Dossier for Submission in the Assessment Procedure for New and Multi-Source (Generic) Products Used in the Treatment of Malaria
(11 pages)

Índice de contenido

	Section 1. Details of the product
	Section 2. Regulatory situation in other countries
	Section 3. Active pharmaceutical ingredient (s) (API)
		Section 3.1 Properties of the active pharmaceutical ingredient(s)
		Section 3.2 Sites of manufacture
		Section 3.3 Route(s) of synthesis
		Section 3.4 Specifications
		Section 3.5 Stability testing
	Section 4. Finished product
		Section 4.1 Formulation
		Section 4.2. Sites of manufacture
		Section 4.3 Manufacturing procedure
		Section 4.4 Specifications for excipients
		Section 4.5 Specifications for the finished product
		Section 4.6 Container/closure system(s) and other packaging
		Section 4.7 Stability testing
		Section 4.8 Container labelling
		Section 4.9 Product information
		Section 4.10 Patient information and package inserts
		Section 4.11 Justification for any differences to the product in the country or countries issuing the submitted WHO-type certificate(s)⁶
	Section 5. Efficacy and safety
		Section 5.1 Bio-equivalence study report
		Section 5.2 Artemisinin containing drug products
		Section 5.3 Summary of pharmacology, toxicology and efficacy of the product

Section 5.3 Summary of pharmacology, toxicology and efficacy of the product

In case of products containing new active ingredients and new combinations of active ingredients provide full information on safety and efficacy as defined in guidelines by the European Union, the US Food and Drug Administration, or the Japanese Ministry of Health and Welfare.

Guidelines. malaria generics