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)

Table des matières

	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

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

(These guidelines are based on the WHO document "Marketing Authorization of Pharmaceutical Products with special Reference to Multisource (Generic) Products: a Manual for a Drug Regulatory Authority, WHO/DMP/RGS/98.5 - full text can be found in the web site http://www.who.int/medicines/)

Note: Manufacturers interested in having their antimalarial drug evaluated for acceptability in principle for procurement by UN Agencies should submit a product dossier reflecting the data and information requested below. The sections should be clearly marked (Section 1 to 4.14).

The covering letter submitted with the product dossier should contain a clear statement by the responsible person submitting the product dossier, indicating that the information submitted is true and correct.