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Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations

We have adopted this International Scientific Guideline - EMEA/CHMP/CVMP/QWP/17760/2009 Rev2 

Last updated

About this guideline

Overseas effective date: 6 December 2014

Replaces: CPMP/QWP/3309/01, EMEA/CVMP/961/01

Note: To be read in conjunction with the Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 2: defining the scope of an NIRS procedure (EMA/CHMP/CVMP/QWP/63699/2014)

Categories: Quality | Specifications, analytical procedures and analytical validation

          Quality | Non-immunologicals

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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For more information see International scientific guidelines adopted in Australia.

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