New FDA Guideline on Size, Shape and Physical Attributes of Generics

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

At the end of 2013, the FDA published a guideline draft entitled "Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules". The Agency saw a need for regulation because of the fact that the dosage forms of generics - particularly tablets and capsules - may considerably differ in shape and size from reference listed drugs (RLD) despite of equivalent pharmacological parameters. The FDA is concerned that this could affect patient compliance and acceptability of medication regimens and thus could pose a risk to patient safety. This mainly applies to patients suffering from dysphagia. For them swallowing a tablet or a capsule of a larger size may be almost impossible.

This guidance addresses companies who want to submit a marketing authorisation dossier in the USA either for a generic medicinal product or for an additional strength of an already authorised generic. The Guidance doesn't apply to already marketed generics and oral dosage forms other than tablets and capsules.

The Guidance formulates requirements with regard to the dimensions, volume measurements and further physical attributes of tablets and capsules which have to be taken into consideration by the generics manufacturers. For example, the largest dimension shouldn't basically exceed 22 mm. For smaller dimensions or volumes of the RLD, the generic dosage form may be larger only within specified limits. If the physical attributes defined in this Guidance are exceeded, the applicant should contact the Agency before submitting the authorisation dossier. Studies in the development phase with dosage forms which have physical attributes outside the limits set have to be described in CTD module 3, chapter 3.2.P.2, "Pharmaceutical Development" or 3.2.P.5.6, "Justification of Specifications".

The provisions on the characteristics of generic oral dosage forms are summarised in the chapter "Recommendations" of the Guidance. Like every FDA Guidance for Industry, the "recommendations" described should be considered as binding as the Agency's reviewers definitely use these regulations. Generics manufacturers who want to get an authorisation for the US-American market should thus accurately align to this Guidance.