Key Takeaways

• “Writing with the end in mind” was the main theme of many speakers. For example, clinical study reports (CSRs) can be written not only for agency reviewers but also to highlight the value of the therapy to other medical professionals who work more closely with patients in the product lifecycle.
• Multi-functional teamwork is crucial not only for successful clinical development of a product, but for successful development of the clinical documents required to move that product through review and approval, and onto the market for patients to access.
• The ongoing and rapid regulatory reform in China requires medical writers to thoroughly understand and expertly interpret local (NMPA) and global (ICH) requirements for high quality submission documents. This challenge is also a tremendous opportunity for medical writers to accelerate document submission, by enabling quicker regulatory review and approval of these documents, so that they are placed in the market for patients in China as early as possible.

Preparing a CSR under the ICH E3 guideline was presented in a principle-to-practice way by (1) reviewing the principles of ICH E3; (2) comparing ICH E3 (global) with NMPA (local) requirements for CSR structure, content, and appendices; and (3) focusing on the Results sections of the CSR.

All speakers noted that keeping in mind the different perspectives of various stakeholders who use the CSR is the key success factor for writing a high-quality CSR. They recommended that streamlining the methodology sections, reducing the synopses, and more sharply focusing the results sections, will create a clear and concise, yet compliant, CSR. This simplified but focused format will also help regulators to review this document more efficiently.

This Theme also confirmed the medical writer’s critical role within the ICH framework as the main coordinator and author of key clinical documents at different stages of the product lifecycle.

• Briefing Document: Preparation of briefing documents was presented to illustrate how they facilitated and improved communication between the sponsor and health authorities; the process, timeline, and key points to include in this briefing document were discussed.
• Common Technical Document (CTD): Health authorities always request comprehensive, accurate, standardized and well-structured clinical documents in Module 2 of the CTD as part of a high-quality submission dossier. The medical writer plays an essential role in both local and global practices for preparing these documents, and in contributing to bridging strategies and methods for local submissions to achieve the ultimate goal of regulatory approval.
• Pharmacovigilance (PV) Documents: This is a relatively specialized area for medical writers in China to explore in the context of regulatory requirements for the structure, content, timeline, and project management of these documents.