The EU Telematics Implementation Group - electronic submissions (TIGes) has released a new version 2.0 of the "TIGes Harmonised Guidance for eCTD Submissions in the EU" and a new version 3.0 of the corresponding Harmonised Guidance for NeeS (human medicinal products).
Both guidance documents have been changed significantly. Corresponding changes have been detailed in the respective release Notes:
TIGes Harmonised Guidance for eCTD Submissions in the EU, version 2.0, August 2011
Release Notes for TIGes eCTD Guidance – Comparison of version 2.0 with 1.0
TIGes Harmonised Guidance for Non-eCTD electronic Submissions (NeeS) for human medicinal products in the EU, version 3.0, August 2011
Release Notes for EU NeeS Guidance – Comparison of version 3.0 with 2.0
For More information please click here: Exalon: EU: Updated harmonized guidances for eCTD and NeeS released by TIGes
No comments:
Post a Comment