What is a dossier in regulatory affairs?

All eyes are on the latest James Bond movie, No Time To Die – but secret dossiers aren’t just the stuff of spy movies.

Such collections of documents – maybe not ‘secret’ but sometimes confidential – also appear in more everyday life, filled with detailed information about a given person or subject.

Dossiers about candidates are used in recruitment, particularly for senior positions. So are dossiers of evidence compiled to back up a particular case or argument in a legal context.

Regulatory affairs is also an area where dossiers are commonplace. In this arena, the term refers to a package of data, facts and figures on a particular topic, such as a new or modified drug or medicinal product.

These files – rigorously set out and meticulously detailed – are provided to meet the requirements of regulators in the EU and US, which must assess matters in great detail before granting Marketing Authorisation Approvals, leading to licensing items to be sold. 

The review and approval of dossiers is therefore a critical activity to ensure patient safety – and for the manufacturers to enable commercialisation.

A dossier is needed for all applications, including clinical trials.  These can be for new products, extensions, variation or renewals and must be set out on particular forms, as part of the package.

What is included in a dossier, in regulatory affairs?

Administrative information relating to the efficacy, quality and safety of a drug product forms the bulk of such a bundle of material, either online or on paper, or both.  This is known as a CTD (Common Technical Document) or eCTD if electronic-only, which is now the mandatory medium globally.

The CTD is a standard, formally structured file, agreed by the International Council of Harmonisation and includes five modules covering nonclinical, clinical, and technical / manufacturing information. 

The format is equally applicable to an NDA (New Drug Application) as it is to a MAA (Marketing Authorisation Application).  Stipulations and therefore contents vary by the stage or product development and country, but some sections are common to all regions.

This internationally-recognised system streamlines processes globally, and aids the smooth consideration and processing of applications.

All CTDs begin with a cover letter offering an overview of the application.  As detail unfolds, cross references can be made to previous submissions and supporting documents such as relevant studies or reports of drug trials.

The physical, chemical, or biological characteristics of the drug in question, information about its manufacturer, and the methods used to assure its identity, strength, quality, and purity are presented and discussed.  Matters such as artworks and labelling are also addressed in full, to demonstrate that strict regulations will be met.

Details of consultation with target patient groups as well as information about approvals previously granted may also be included where relevant.  The scientific parts of the collection of documents, signed by experts, typically include summaries, quality reports, clinical and non-clinical reviews, and declarations.  As a more recent development, environmental impact risk assesments are also submitted.

In summary, putting together a regulatory affairs dossier for a medicinal product requires processes that, when combined, can be complex and time-consuming tasks, involving the assembling and updating material from various individual document sources and formats.

If you would like to know more, or would like some help with this task, please contact us to see how we could support you.