Structure of Dossier of Medicinal Product- Q part. Gabriel K. Kaddu Head, Drug Assessment and Registration National Drug Authority.
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Gabriel K. Kaddu
Head, Drug Assessment and Registration
National Drug Authority
Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.
Outline of presentation
Common Technical Document
An initiative under the ICH: Europe, Japan and USA.
A quality CEP certifies that the quality of the substance can be checked according to the Ph. Eur. by applying the analytical methods described in the Ph. Eur. monograph supplemented by those appended to the CEP.
Quality dossier / Section 3
Finished Pharmaceutical Product
3.1. Manufacturing and marketing authorization
3.2. Pharmaceutical development
3.4. Sites of manufacture
3.5. Manufacturing process
3.6. Manufacturing process controls of Critical steps and intermediates
3.7. Process validation and Evaluation
3.8. Specifications for excipients
3.9. Control of the FPP
3.10. Container/closure system (s) and other packaging
3.11. Stability testing
3.12. Container labelling
3.13. Product information for health professionals
3.14. Patient information and package leaflet
3.15. Justification for any differences to the product in the country or countries issuing the submitted WHO-type certificate(s)
THANK YOU to the WHO PQ team