Development pharmaceutics for biotechnological and biological products (CPMP/BWP/328/99) Annex to note for guidance on development pharmaceutics (CPMP/QWP/155/96)

We have adopted this International Scientific Guideline - CPMP/BWP/328/99.

Last updated

3 June 2024

About this guideline

Overseas effective date: April 2000

Categories: Biologicals | Finished product | Pharmaceutical development

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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