Stability Regulations
This segment is a growing collection of laws, guidances and requirements pertaining to the stability function from various nations and recognized global and regional organizations. While some are legal requirements, others are guidances that can be fulfilled with justified alternative measures, but all are expectations of duly authorized regulatory bodies.
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Regulations by Regulatory Body
…or use the search to discover other stability regulations!
Brazil (ANVISA) Quality
Vistaar Blog regarding ANVISA Resolution RDC 318/2019 (Also linked in Publications)
Canada (HC) GMP
Issued August 2020
Canada (HC) Quality
Superceded by 2017 Quality CMC
Canada (HC) Submissions
Effective 30 January 2018
EU (EC) Regulations
Issued 14 December 2005
EU (EC) Regulations
Annex 1 Consultation Document December 2020
EU (EMA) CHMP
Effective June 2008
EU (EMA) CPMP
Adopted by CPMP February 2001
EU (EMA) CVMP
First Published: 13 October 2023, Consultation dates: 13 October 2023 to 05 January 2024
EU (EMA) CVMP
First Published 12 October 2007
EU (EMA) Quality
Intended as an annex to stability guidelines and relates to marketing authorizations for all product categories. Last updated 19 November 2007.
EU (EMA) Quality
Questions and Answers, dated 23 July 2015
EU (EMA) Quality
Dated 22 June 2017
EU (EMA) Quality
Dated February 2002
EU (EMA) Quality
Dated July 1996
EU (EMA) Quality
For guidance on biotechnological/biological products subject to changes in their manufacturing process. Dated June 2005
EU (EMA) Quality
Step 5 dated November 2000
Internation (ICH) Q
Final version, adopted on 20 November 2019
International (ASEAN) ATSC
Version 1.0 (2013)
International (ICH) M
Final version, adopted on 24 May 2022
International (ICH) M
Document date: 11 November 2022
International (ICH) M
International (ICH) Q
This is a concept paper endorsed by the Management Committee on 15 November 2018
International (ICH) Q
Formerly Q1F (withdrawn), this guidance was published as Annex 2 in the WHO Technical Report Series, No. 953, 2009
International (ICH) Q
Current Step 4 version dated 4 June 2008
International (ICH) Q
Current Step 4 Version Dated 1-May-2012
International (ICH) Q
Draft version endorsed on 27 July 2021. Currently under public consultation.
International (ICH) Q
Current Step 4 version dated 6 February 2003
International (ICH) Q
Current Step 4 version dated 6 November 1996
International (ICH) Q
This version is dated 6 November 1996 and is an annex to the ICH Guideline on Stability Testing for New Drugs and Products.
International (ICH) Q
Current Step 4 version dated 6 February 2003
International (ICH) Q
Current Step 4 version Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005)
International (ICH) Q
Current Step 4 version dated 25 October 2006
International (ICH) Q
Current Step 4 version dated 2 June 2006
International (ICH) Q
Current Step 4 version (R8) dated 22 April 2021
International (ICH) Q
Current Step 4 version dated 22 April 2021
International (ICH) Q
Endorsed by the ICH Steering Committee on 21 October 2014
International (ICH) Q
Final version, adopted on 22 March 2019
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