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21 August 2006

EMEA Plans Revision of NIR Guideline

On 27 June 2006 EMEA published the "Concept paper on revision of the note for guidance of the use of Near Infrared Spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations". The revision was necessary due to new developments in this area, authority experience as well as due to feedback from the pharmaceutical industry. The Concept Paper discusses items like:

  • Since completing the first NIR Guideline (2001-2002) authorities as well as the industry gained plenty of experience with NIR
  • Thus, detailed requirements as until now will not be necessary in the future
  • In addition new regulations (e.g. ICH Q8, or PAT) will impact this guideline
  • The Ph.Eur. describes the common methods in more detail now; the future guideline will thus not have to describe them that thoroughly
  • The future guideline will have to clarify, what data are GMP data, and what information will have to be submitted for marketing authorisation applications or change notifications.

The revised guideline is supposed to become effective in the second quarter of 2009.

The complete document is available here.

NIR will also be introduced as one of FDA's PAT-Initiative key technologies - at the

University of Heidelberg PAT Conference
with FDA and EU Authority Speakers

co-sponsored by ECA. Get the latest update in Heidelberg from 27-29 September.
Among the Speakers are

  • Dr Chris Watts, FDA, Member of the PAT Policy Team,
  • Prof Christina Graffner, MPA, Expert of the ad hoc EU-PAT group of EMEA's scientific committees,
  • Dr Ajaz Hussain, Sandoz Inc., USA, formerly FDA's PAT Expert Group Leader,

as well as Speakers from SanofiAventis, Astra Zeneca, Roche, GlaxoSmithKline, Schering and many more.

Please visit:

Dr Gnter Brendelberger
On behalf of the European Compliance Academy (ECA)


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