What is the long-term storage condition for stability studies?

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SFDA: “* GCC States are categorized in climatic zones III & IV a.” (GCC v3.3 (archived) · 2. Glossary – Climatic zone (table footnote)) “Long-term 30 °C ± 2 °C/ 65% RH ± 5% RH” (GCC v3.3 (archived) · 3.2.6.1 General case (FPP table)) EU: “Details of the conditions recommended for these stability studies are included in the relevant CHMP/ICH Guidelines where storage conditions for real time studies were chosen as 25°C/60% RH supported by accelerated or, where applicable, intermediate conditions and based on the mean kinetic temperature of climatic zone I/II, the relevant zone for the EU.” (EMA storage declaration · A. 1. Background) “The mean kinetic temperature in any part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV. This guideline addresses climatic zones I and II.” (ICH Q1A(R2) · 1.3 General Principles) “Long term* 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH” (ICH Q1A(R2) · 2.2.7.1 General case (table)) US FDA: “The mean kinetic temperature in any part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV.  This guidance addresses climatic zones I and II.” (FDA Q1A(R2) · 1.3) “Long-term* 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH 12 months” (FDA Q1A(R2) · 2.2.7.1 (table)) “It is up to the applicant to decide whether long-term stability sturdies [sic] are performed at 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH.” (FDA Q1A(R2) · 2.2.7.1 (table footnote *)) WHO: “Whether long-term stability studies are performed at 25 °C ± 2 °C/60% RH ± 5% RH or 30 °C ± 2 °C/65% RH ± 5% RH or 30 °C ± 2 °C/75% RH ± 5% RH is determined by the climatic zone in which the FPP is intended to be marketed. Testing at a more severe long-term condition can be an alternative to storage at 25 °C/60% RH or 30 °C/65% RH.” (WHO TRS 1010 Annex 10 · 2.2.7.1 General case, table footnote a) “Saudi Arabia 30 °C/65% RH¹” (WHO zone table 2021 · Table, Regional Office for the Eastern Mediterranean (EMRO), p. 4) “United Kingdom 25 °C/60% RH or 30 °C/65% RH¹” (WHO zone table 2021 · Table, Regional Office for Europe (EURO), p. 5) “United States of America 25 °C/60% RH or 30 °C/65% RH¹” (WHO zone table 2021 · Table, Regional Office for the Americas (AMRO), p. 3) “1 Information obtained through respective regional harmonization groups (e.g. ASEAN, ICH and GCC) and from official communications from national medicines regulatory authorities to WHO (entries in bold type).” (WHO zone table 2021 · Table, footnote 1)

What is the long-term storage condition for stability studies?

SFDA Saudi Food and Drug Authority

EU European Union

US FDA US Food and Drug Administration

WHO World Health Organization

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