ICH HARMONISED TRIPARTITE G - Columbia Pharma

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICALREQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMANUSEICH HARMONISED TRIPARTITE GUIDELINESTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTSR ecommended for Adoptionat Step 4 of the ICH Processon 27 October 1993by the ICH Steering CommitteeThis Guideline has been developed by the appropriate ICH Expert Working Groupand has been subject to consultation by the regulatory parties, in accordance withthe ICH Process. At Step 4 of the Process the final draft is recommended foradoption to the regulatory bodies of the European Union, Japan and TESTING OF NEW DRUG SUBSTANCES AND PRODUCTSICH HARMONISED TRIPARTITE GuidelineEndorsed by the ICH Steering Committee at Step 4 of the ICH Process27 October 1993 PREAMBLEThe following guideline sets out the stability testing requirement for aRegistration Application within the three areas of the EC, Japan and the USA.

ICH Harmonised Tripartite Guideline Endorsed by the ICH Steering Committee at Step 4 of the ICH Process 27 October 1993 PREAMBLE The following guideline sets out thestability testing requirement for a Registration Application within the three areas of the EC, Japan and the USA. It

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  Guidelines, Harmonised, Ich harmonised tripartite, Tripartite, Ich harmonised tripartite guideline

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