CDER published Q&A Catalogue for Generic Drug Authorisations

In September 2021, the CDER (Center for Drug Evaluation and Research) of the U.S. FDA published a so-called "Draft Guidance for Industry" in the form of a question and answer catalogue.

This catalogue highlights frequently asked questions during the submission and approval of marketing authorizations for generics and provides answers and guidance to marketing authorization holders and generic drug manufacturers. The items listed in the document "Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry" address quality and regulatory issues and should be considered as recommendations.

In addition to other topics, the following points are discussed

  • Changes to the container closure system (point 2),
  • number of batches required for stability studies (point 5) and 
  • their packaging materials (point 7)

Point 2 "Container Closure Changes"

This paragraph discusses two questions and answers regarding packaging materials of generics.

First, an example is used to illustrate that the generic product does not have to have the same container closure system (CCS) as the reference product. During the review of the marketing authorization application (ANDA: abbreviated new drug application), any differences between the two packaging systems, the generic and the reference product, are worked out and examined to see if they affect the labeling and intended use.

In principle, the marketing authorization application must show that the generic product has the same intended use and the same labeling, with some acceptable differences.

In the second subitem, it is recommended to use the colors for caps of ophthalmic products as specified by the AAO (American Academy of Ophthalmology). If this is not handled accordingly, a justification for this must be submitted.

Guidelines and references are provided and recommended for each of the two blocks of questions.

Point 5 "Number of Batches"

This paragraph deals with explanations around the topic of stability data and considers the special case where more than one manufacturing site is used to manufacture the generic medicinal product. This requires that stability data from three batches of each manufacturing site and each product strength be submitted with the marketing authorization application. In addition to these recommendations for further guidance, the Q&A document also provides guidance on the possible compositions of the required batch quantities.

Point 7 "Packaging"

Point 7 highlights two issues regarding the packaging material of batches used to provide stability data.

This paragraph begins with the question of whether those three batches used for stability purposes must be packaged completely (i.e., in their commercial packaging) and indicates the requirements according to the FDA guidance.

In this context, the second question sheds light on the specifics of "combination products" consisting of an injector and an injectable medicinal product in a cartridge and comparable products.

Please also see the complete questions and answers in the draft version of the CDER's Q&A document.

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