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A Briefing Document (BRD), also called briefing book or briefing package, is a compilation of relevant information provided to a regulatory decision-making body/entity. Its purpose is to summarize critical information and support interactions with health authorities, at several stages of development (preclinical, clinical, also post authorization). Feedback is provided by the health authority during a meeting, or in writing.
Besides providing background information, the BRD formulates different questions with the goal of getting the health authority to address the issues. To facilitate this process, the document contains proposed solutions for the presented questions and appropriate supporting data. These questions can concern quality (manufacturing, chemical, pharmaceutical and biological testing), non-clinical (toxicological and pharmacological tests), clinical aspects (trials in human participants, including clinical pharmacological trials), or issues relating to interpretation and implementation of guidelines.
There are many types of BRDs, which need to be tailored to the needs of the situation and to the requirements of the health authority concerned. These documents often require, depending on the issues, input from different functions (CMC, non-clinical, clinical, regulatory, …).
The BRD is not updated; however, revisions of draft briefing books during the procedure are possible, to implement health authority feedback.
Emtex Life Science medical writers can play an important role in the document development process (eg, compile contributions, circulate for review, implement comments). If applicable, the Medical Writer can also help to draft the clinical contribution.
FAQ: Briefing Document
What is a Briefing Document (BRD) and what information does it contain?
A BRD is a compilation of information submitted to a regulatory decision‑making body. It contains background information, specific questions for the health authority, proposed solutions, and supporting data related to quality, non‑clinical, or clinical aspects. The goal of the BRD is to help the health authority review the issues and provide feedback during a meeting or in writing.
When is a BRD needed during product development?
A BRD is needed when a company seeks input from a health authority at different stages of development, including preclinical, clinical, and post‑authorization phases. It is used to request clarification, confirm a development strategy, discuss study results, or address guideline interpretation questions.
How is a BRD structured to support discussions with a health authority?
A BRD is structured to clearly present the issue, the related background information, and the specific question for the health authority. It also includes proposed solutions or options to guide the discussion. This structure helps the health authority review the information efficiently and provide focused feedback.
How can Emtex Life Science support the preparation of a BRD?
Emtex Life Science can support the BRD process by coordinating input from all functions involved (such as CMC, non-clinical, clinical, and regulatory), compiling contributions, managing review cycles, implementing comments, and ensuring consistency across the document. If needed, Emtex can also draft the clinical section to ensure clarity and alignment with regulatory expectations.
Why is professional medical writing support valuable for a BRD?
Professional medical writing support is valuable because a BRD must be clear, accurate, and aligned with regulatory expectations. A medical writer ensures the document is well‑organized, the key issues are clearly formulated, and the proposed solutions are logically presented. This improves the quality of the submission and helps facilitate an efficient and productive interaction with the health authority.