Q1C - Stability Testing: Requirements for New Dosage Forms
Health Canada ICH Coordinator
January 18, 1999
To Associations, Registrars of Medicine, Registrars of Pharmacy:
I am pleased to inform you of the release of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH)/Therapeutic Products Programme guideline, "Stability Testing: Requirements for New Dosage Forms". 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. The ICH Steering Committee has endorsed the final draft and has recommended its adoption by the regulatory bodies of the European Union, Japan and the United States
The Therapeutic Products Programme has adopted this international guideline. In accordance with ICH rules, the document was adopted verbatim. This guideline, which is an annex to the ICH guideline "Stability Testing of New Drug Substances and Products", represents an approach that will be considered acceptable for the review of new drug substances and products. This document should be read in conjunction with the relevant sections of other applicable TPP guidelines
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Therapeutic Products Programme Guideline
ICH Harmonised Tripartite Guideline
Published by authority of the Minister of Health
For more information, please contact:
Therapeutic Products Programme
The material herein was prepared under the direction of the Therapeutic Products Programme, Health Canada. No changes are permitted.
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Catalogue No. H42-2/78-1998E
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. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.
The Therapeutic Products Programme (TPP) has adopted this guideline and reproduced it in this document. This guideline represents an approach that will be considered acceptable for the review of new drug substances and products. This document should be read in conjunction with the relevant sections of other applicable Directorate guidelines.
Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. Submission sponsors may discuss, in advance, alternate approaches with the Directorate to avoid the withdrawal/ rejection of a submission.
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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