INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN
USE
ICH HARMONISED TRIPARTITE GUIDELINE
STABILITY TESTING FOR NEW DOSAGE FORMS
Annex to the ICH Harmonised Tripartite Guideline on
Stability Testing for New Drugs and Products
Q1C
Current Step 4 version
dated 6 November 1996
This Guideline has been developed by the appropriate ICH Expert Working Group and
has been subject to consultation by the regulatory parties, in accordance with the ICH
Process. At Step 4 of the Process the final draft is recommended for adoption to the
regulatory bodies of the European Union, Japan and USA.
1
Q1C
Document History
First
Codification History Date
New
Codification
November
2005
Q1C Approval by the Steering Committee under Step 2
and release for public consultation.
29
November
1995
Q1C
Current Step 4 version
Q1C Approval by the Steering Committee under Step 4
and recommendation for adoption to the three ICH
regulatory bodies.
6
November
1996
Q1C
2
STABILITY TESTING FOR NEW DOSAGE FORMS
Annex to the ICH Harmonised Tripartite Guideline on
Stability Testing for New Drugs and Products
ICH Harmonised Tripartite Guideline
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting
on 6 November 1996, this guideline is recommended for adoption
to the three regulatory parties to ICH
1. GENERAL
The ICH harmonised Tripartite Guideline on Stability Testing of New Drug
Substances and Products was issued on October 27, 1993. This document is an
annex to the ICH parent stability guideline and addresses the recommendations
on what should be submitted regarding stability of new dosage forms by the
owner of the original application, after the original submission for new drug
substances and products.
2. NEW DOSAGE FORMS
A new dosage form is defined as a drug product which is a different
pharmaceutical product type, but contains the same active substance as included
in the existing drug product approved by the pertinent regulatory authority.
Such pharmaceutical product types include products of different administration
route (e.g., oral to parenteral), new specific functionality/delivery systems
(e.g., immediate release tablet to modified release tablet) and different dosage
forms of the same administration route (e.g., capsule to tablet, solution to
suspension).
Stability protocols for new dosage forms should follow the guidance in the parent
stability guideline in principle. However, a reduced stability database at
submission time (e.g., 6 months accelerated and 6 months long term data from
ongoing studies) may be acceptable in certain justified cases.
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