'Femi Fajimi

From a Regulatory Medical Writer’s Perspective

-By Femi Fajimi | 27 September 2026-

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For decades, regulatory medical writing has been largely document-centric.

Protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and regulatory summaries are developed as separate documents, often drawing on the same underlying sources.

When an endpoint changes, a study population is revised, or safety information is updated, the challenge rarely stops at one paragraph.

The question becomes:

Where else does this information appear?

That question highlights an important limitation of document-centric authoring—and helps explain why structured content is becoming increasingly relevant to regulatory medical writing.

From documents to structured information

Traditional medical writing treats the document as the primary unit of work.

The writer develops the document, reviewers comment on it, revisions are incorporated, and quality control ensures that the final version is accurate and internally consistent.

But regulatory information rarely exists within only one document.

Consider something as simple as a study endpoint. It may appear in the protocol and subsequently inform other clinical and regulatory documents. When that information changes, maintaining consistency depends on identifying everywhere the change has consequences.

Structured content approaches the problem differently.

Rather than treating information solely as prose within a document, content can also be considered according to what it represents, where it originates, and how it may be exchanged or reused.

This does not eliminate writing.

It changes how we think about what we are writing.

ICH M11: an important signal

The final ICH M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP) guideline was adopted in November 2025.

M11 introduces a harmonised clinical protocol template, but perhaps more interestingly, it is accompanied by a Technical Specification defining data elements and technical attributes that enable interoperable electronic exchange of protocol content.

This is significant.

A protocol remains a regulatory document, but the information within it can increasingly be understood as structured information capable of electronic exchange, rather than simply text occupying predefined sections.

ICH itself describes M11 as supporting the transition toward electronic protocol formats with structured data elements, with potential benefits including automated processing, improved data quality, and integration with electronic systems used in drug development and regulatory review.

Where does eCTD v4.0 fit?

eCTD v4.0 represents another part of the evolution of regulatory information management.

It should not be confused with structured content authoring itself. eCTD is the standard used to organise and exchange regulatory submissions rather than a system for writing clinical documents.

However, v4.0 advances the technical framework for identifying and managing regulatory information across the submission lifecycle.

FDA has accepted new regulatory applications in eCTD v4.0 since September 2024, while implementation of additional functionality continues. FDA updated several of its eCTD v4.0 technical resources again in August 2026.

Together, developments such as ICH M11 and eCTD v4.0 point toward a regulatory environment in which information is becoming increasingly structured, interoperable, and machine-readable.

What does this mean for medical writers?

It does not mean medical writers need to become programmers.

Nor does it mean Microsoft Word is about to disappear.

But it may mean that understanding the architecture surrounding regulatory content becomes increasingly valuable.

The traditional question:

“Is this paragraph scientifically accurate and well written?”

remains essential.

But additional questions become relevant:

Where did this information originate?

Where else is it used?

How is it structured?

What happens downstream when it changes?

In that environment, consistency becomes more than an editorial concern.

It becomes a content-governance and information-management concern.

Medical writers who understand concepts such as structured content, metadata, interoperability, content reuse, and information lifecycle may therefore be better positioned to work within evolving regulatory-authoring environments.

Writing still matters

Technology does not remove the central responsibilities of regulatory medical writing.

A structured data element cannot independently determine whether an efficacy interpretation is scientifically justified.

Metadata cannot decide whether uncertainty has been communicated appropriately.

Automation cannot replace the contextual judgement required to develop a coherent regulatory narrative from complex clinical evidence.

Those remain human responsibilities.

The change is therefore unlikely to be simply human writing versus automated writing.

It may be a change in what surrounds the writing.

Beyond the document

The future of regulatory medical writing may not involve documents disappearing at all.

The more meaningful transition may be from thinking primarily about documents to thinking about the regulatory information from which those documents are constructed.

Medical writers will still need to write clearly, interpret evidence, and understand regulatory expectations.

But increasingly, they may also need to understand how information is structured, governed, exchanged, and reused.

The regulatory medical writer of the future may still write the document—but may increasingly help architect the information behind it.