Medicines

45th Expert Committee on Specifications for Pharmaceutical Preparations

Geneva, 18-22 October 2010

For submissions of comments please use the following forms...

Working documents

Regulatory guidance:

Quality requirements for Artemisinin as a starting material in the production of Antimalarial active pharmaceutical Ingredients (APIs)
pdf, 229kb
Pharmaceutical development for multisource (generic) pharmaceutical products
pdf, 726kb
Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product (FPP): quality part
pdf, 1.45Mb
Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product (FPP): Preparation of product dossiers (PDS) in common technical document (CTD) format
pdf, 722kb
WHO guidelines for drafting a site master filê
pdf, 146kb
Development of paediatric medicines: points to consider in pharmaceutical development
pdf, 575kb

GMP:

Distribution and related practices :

Joint FIP/WHO guidelines on good pharmacy practice: Standards for quality of pharmacy services
pdf, 476kb

Quality assurance guidance:

Laboratory:

Prequalification:

Legislation and nomenclature:

Specifications

Anti-infectives

Antimalarials:

Anti-TB:

ARVs:

Other medicines:

Paediatric:

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