What stability data is required at submission for a generic product?

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SFDA: “In the case of conventional dosage forms with APIs that are known to be stable, data from at least two primary batches should be provided.” (GCC v3.3 (archived) · 3.2.2 Selection of batches) “If the product is registered and marketed in the country of origin, at least one of the batches used in submitted stability study should be of a production scale.” (GCC v3.3 (archived) · 3.2.2 Selection of batches) “For generic products that are marketed in the country of origin, long-term stability study supporting the complete proposed shelf-life should be submitted.” (GCC v3.3 (archived) · 3.2.6.1 General case (table footnote *)) EU: “… a) For conventional dosage forms (e.g. immediate release solid dosage forms, solutions) and when the active substances are known to be stable, stability data on at least two pilot scale batches are acceptable.” (EMA existing actives · 2.2.3 Selection of Batches) “… b) For critical dosage forms or when the active substances are known to be unstable, stability data on three primary batches are to be provided. Two of the three batches should be of at least pilot scale, the third batch may be smaller.” (EMA existing actives · 2.2.3 Selection of Batches) “Long term* 25° C ± 2° C/60% RH ± 5% RH or 30° C ± 2° C/65% RH ± 5% RH 6 months (option a) 12 months (option b) Intermediate 30° C ± 2° C/65% RH ± 5% RH 6 months Accelerated 40° C ± 2° C/75% RH ± 5% RH 6 months” (EMA existing actives · 2.2.7.1 General case (table)) US FDA: “Submit data from three pilot scale batches or two pilot scale batches and one small scale batch.  If the size of the pilot scale batch does not follow ICH recommendations, the applicant should provide a justification.” (FDA ANDA stability 2013 · III (Discussion), item 1) “At the time of submission, provide 6 months of data that include accelerated and long-term conditions.  FDA recommends following ICH guidelines with respect to utilization of intermediate conditions to support shelf-life.” (FDA ANDA stability 2013 · III (Discussion), item 2) “Two of the three batches should be of at least 10 percent of the proposed production batch or 100,000 finished dosage units, whichever is greater (i.e., pilot scale batches).  The third batch can be smaller than the 10 percent of the proposed production batch, but should not be less than 25 percent of the pilot scale batch.” (FDA ANDA stability Q&A 2014 · II.C, A13 (Oral dosage forms, (a) Tablets/Capsules)) WHO: “For FPPs containing existing APIs (e.g. generics), data should be provided on not less than two batches of at least pilot scale, or in the case of an uncomplicated³ FPP (e.g. immediate-release solid FPPs (with noted exceptions) or non-sterile solutions), at least one batch of at least pilot scale and a second batch which may be smaller (e.g. for solid oral dosage forms, 25 000 or 50 000 tablets or capsules) of each proposed strength of the FPP.” (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 generic product?

SFDA Saudi Food and Drug Authority

EU European Union

US FDA US Food and Drug Administration

WHO World Health Organization

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