What stability data is required at submission for a product with a new active substance?

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SFDA: “Data from stability studies should be provided on at least three primary batches of the FPP.” (GCC v3.3 (archived) · 3.2.2 Selection of batches) “Two of the three batches should be at least pilot-scale batches and the third one can be smaller, if justified.” (GCC v3.3 (archived) · 3.2.2 Selection of batches) “Minimum time period covered by data at submission Long-term 30 °C ± 2 °C/ 65% RH ± 5% RH 12 months* Accelerated 40 °C ± 2 °C/ 75% RH ± 5% RH 6 months” (GCC v3.3 (archived) · 3.2.6.1 General case (FPP table)) EU: “The long term testing should cover a minimum of 12 months’ duration on at least three primary batches at the time of submission and should be continued for a period of time sufficient to cover the proposed shelf life.” (ICH Q1A(R2) · 2.2.7 Storage Conditions) “Two of the three batches should be at least pilot scale batches and the third one can be smaller, if justified.” (ICH Q1A(R2) · 2.2.3 Selection of Batches) “Accelerated 40°C ± 2°C/75% RH ± 5% RH 6 months” (ICH Q1A(R2) · 2.2.7.1 General case (table)) US FDA: “Data from stability studies should be provided on at least three primary batches of the drug product.” (FDA Q1A(R2) · 2.2.3) “Two of the three batches should be at least pilot scale batches, and the third one can be smaller if justified.” (FDA Q1A(R2) · 2.2.3) “The long-term testing should cover a minimum of 12 months’ duration on at least three primary batches at the time of submission and should be continued for a period of time sufficient to cover the proposed shelf life.” (FDA Q1A(R2) · 2.2.7) WHO: “For FPPs containing new APIs, data from stability studies should be provided on at least three primary batches of each proposed strength of the FPP. Two of the three batches should be at least pilot-scale batches and the third batch can be smaller, if justified (see example below).” (WHO TRS 1010 Annex 10 · 2.2.3 Selection of batches) “At the time of submission, the long-term testing should cover a minimum of six months for FPPs containing existing APIs or 12 months for FPPs containing new APIs and should be continued for a period of time sufficient to cover the proposed shelf life.” (WHO TRS 1010 Annex 10 · 2.2.7 Storage conditions) “Study Storage condition Minimum time period covered by data at submission Intermediateᵇ 30 °C ± 2 °C/65% RH ± 5% RH 6 months Accelerated 40 °C ± 2 °C/75% RH ± 5% RH 6 months” (WHO TRS 1010 Annex 10 · 2.2.7.1 General case (table, continued))

What stability data is required at submission for a product with a new active substance?

SFDA Saudi Food and Drug Authority

EU European Union

US FDA US Food and Drug Administration

WHO World Health Organization

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