11 Regulatory Affairs Professionals Society
Introduction
Regulatory writing – which interweaves language, science
or engineering, medicine, and law – creates communications
deliverables that advance medical, scientific, and manufac-
turing objectives. In biopharmaceutical, vaccine, and device
development, a regulatory writer’s principal goal is to produce
documents for submission to health authorities that are scientif-
ically and editorially accurate, a reflection of regulatory strategy
and corporate goals, compliant with applicable regulations and
guidelines, and clearly worded concerning key messages.
Regulatory documents often feature multiple authors
across several subject matter areas. This practice presents
challenges to producing writing in one consistent voice.
Well-designed documents provide information that the audi-
ence can easily understand and interpret. When producing
regulatory deliverables, authors, reviewers, and editors should
consider the following questions:
• Does the document present one clear, consistent repre-
sentation or narrative of the data?
• Are the safety information and risks disclosed and dis-
cussed adequately? Is adequate information included to
support safety conclusions?
• Is all information and terminology consistent?
• Are previous discussions with the health authority
addressed and consistent with all prior meeting minutes?
Regulatory writers must always keep their intended readers in
mind, particularly in terms of word choice and level of detail.
Teamwork for Success
The team should clarify expectations and roles early in the
writing process and ensure team members understand the
importance of their editorial and writing tasks. Rapport-
building and communication are critical to promoting this
understanding. One editorial team member and one content
expert team member could be responsible for assessing and
presenting key messages and conclusions within documents
Barriers to Effective
Communication
Effective regulatory communication must produce clear,
accurate exchange of key medical, scientific, and quality
messages and explain complex data. Recipients of regulatory
documents include health authority reviewers, including the
US Food and Drug Administration (FDA), the European
Medicines Agency, European notified bodies, physician
investigators, study coordinators, Institutional Review Board
members, pharmacists, and insurance providers. As readers,
these groups have varying needs.
Poor communication can have real and costly conse-
quences. Some examples include the following:1
• Health authorities may misunderstand a submission and
be unable to complete the review or give the sponsor a
timely answer.
• Submission content may not support the key messages or
desired label indications.
• Health authorities may question the content, raising
more issues than it answers.
• Health authorities may refuse to review dossiers that
seem deficient in content or format.
• Reviewers may spend more time searching for relevant
sections and information than reviewing them.
Sloppy submissions can create a negative impression of the
submission and the organization that wrote it. And once that
stage is reached, the reviewer may be more disposed to iden-
tify deficiencies because of low expectations for the overall
submission. If the regulator loses faith in the organization,
deficiencies may be more difficult to resolve because address-
ing technical issues is not the only action needed to redeem
the company in the regulatory reader’s opinion.
Text that is too dense or written mainly in the pas-
sive voice is challenging to read, comprehend, and assess.
Inconsistent information can raise questions that delay or
confound a regulatory decision.
2 General Considerations for
Quality Regulatory Writing
E. Mitchell Seymour, PhD, RAC-US
Introduction
Regulatory writing – which interweaves language, science
or engineering, medicine, and law – creates communications
deliverables that advance medical, scientific, and manufac-
turing objectives. In biopharmaceutical, vaccine, and device
development, a regulatory writer’s principal goal is to produce
documents for submission to health authorities that are scientif-
ically and editorially accurate, a reflection of regulatory strategy
and corporate goals, compliant with applicable regulations and
guidelines, and clearly worded concerning key messages.
Regulatory documents often feature multiple authors
across several subject matter areas. This practice presents
challenges to producing writing in one consistent voice.
Well-designed documents provide information that the audi-
ence can easily understand and interpret. When producing
regulatory deliverables, authors, reviewers, and editors should
consider the following questions:
• Does the document present one clear, consistent repre-
sentation or narrative of the data?
• Are the safety information and risks disclosed and dis-
cussed adequately? Is adequate information included to
support safety conclusions?
• Is all information and terminology consistent?
• Are previous discussions with the health authority
addressed and consistent with all prior meeting minutes?
Regulatory writers must always keep their intended readers in
mind, particularly in terms of word choice and level of detail.
Teamwork for Success
The team should clarify expectations and roles early in the
writing process and ensure team members understand the
importance of their editorial and writing tasks. Rapport-
building and communication are critical to promoting this
understanding. One editorial team member and one content
expert team member could be responsible for assessing and
presenting key messages and conclusions within documents
Barriers to Effective
Communication
Effective regulatory communication must produce clear,
accurate exchange of key medical, scientific, and quality
messages and explain complex data. Recipients of regulatory
documents include health authority reviewers, including the
US Food and Drug Administration (FDA), the European
Medicines Agency, European notified bodies, physician
investigators, study coordinators, Institutional Review Board
members, pharmacists, and insurance providers. As readers,
these groups have varying needs.
Poor communication can have real and costly conse-
quences. Some examples include the following:1
• Health authorities may misunderstand a submission and
be unable to complete the review or give the sponsor a
timely answer.
• Submission content may not support the key messages or
desired label indications.
• Health authorities may question the content, raising
more issues than it answers.
• Health authorities may refuse to review dossiers that
seem deficient in content or format.
• Reviewers may spend more time searching for relevant
sections and information than reviewing them.
Sloppy submissions can create a negative impression of the
submission and the organization that wrote it. And once that
stage is reached, the reviewer may be more disposed to iden-
tify deficiencies because of low expectations for the overall
submission. If the regulator loses faith in the organization,
deficiencies may be more difficult to resolve because address-
ing technical issues is not the only action needed to redeem
the company in the regulatory reader’s opinion.
Text that is too dense or written mainly in the pas-
sive voice is challenging to read, comprehend, and assess.
Inconsistent information can raise questions that delay or
confound a regulatory decision.
2 General Considerations for
Quality Regulatory Writing
E. Mitchell Seymour, PhD, RAC-US