Regulatory and Compliance Communication

For professionals whose first language is not English, understanding regulatory documents can be challenging. Regulatory language often includes technical, legal, and scientific terminology that may not be commonly encountered in everyday communication. Additionally, the formal tone and strict adherence to regulatory standards can make the language feel complex and rigid. However, mastering this style of communication is essential for success in regulatory affairs.

This article explores how professionals can sharpen their regulatory and compliance communication skills, ensuring that their words are not just understood, but trusted, in one of the most highly regulated industries in the world.

1. Regulatory Language: Terms Used in Regulatory Documents

Regulatory language refers to the formal and structured use of language in official regulatory documents. It is designed to be precise, clear, and compliant with legal and scientific standards, ensuring that there is no ambiguity in the requirements set out by regulatory authorities.

Common Regulatory Terms:

Authorization

Formal approval granted by a regulatory authority to market or use a product.

Marketing authorization for a new drug after successful clinical trials.

Submission

The process of sending documents and data to regulatory authorities for evaluation.

IND submission for a new therapy.

Approval

Confirmation from a regulatory body that a product meets the required standards for use.

FDA approval for market release after Phase III trials.

Compliance

Adherence to laws, guidelines, and regulations set by regulatory authorities.

Compliance with GMP during the manufacturing of pharmaceuticals.

Labelling

Information accompanying a product, including instructions, warnings, and ingredients.

Updated product labelling to include safety warnings.

Protocol

A detailed plan that outlines how a clinical trial will be conducted.

Clinical trial protocol for a Phase III study on cancer treatment.

Risk Management

The process of identifying, evaluating, and mitigating risks associated with a product.

Risk management plan in an NDA submission.

Adverse Event

An unintended and harmful outcome associated with the use of a medical product.

Reporting adverse events during post-marketing surveillance.

Audit

A formal examination of records or processes to ensure compliance with regulatory standards.

GMP audit conducted to ensure compliance with FDA standards.

Pharmacovigilance

Monitoring the safety of pharmaceutical products after they are on the market.

Pharmacovigilance to track adverse events in patients post-market.

Inspection

Review by regulatory authorities to ensure compliance with laws and standards.

FDA inspection of a drug manufacturing facility.

Investigational Product

A drug or device under investigation in a clinical trial.

Investigational product used in Phase II clinical trials for diabetes.

Dossier

A collection of documents submitted for product evaluation by regulatory authorities.

Submission of a complete dossier for regulatory approval of a biosimilar.

Clinical Hold

A suspension imposed on a clinical trial due to safety concerns or lack of data.

FDA imposes a clinical hold pending additional safety data.

Endpoint

A specific outcome used to measure the effectiveness of a treatment in a clinical trial.

Primary endpoint in a cancer drug trial is overall survival.

Post-Marketing Surveillance

Monitoring of a product's performance after release to ensure ongoing safety.

Post-marketing surveillance of a newly approved vaccine.

Good Clinical Practice (GCP)

An international quality standard for designing and conducting clinical trials.

Clinical trials are conducted following GCP guidelines.

Good Manufacturing Practice (GMP)

Standards ensuring products are consistently produced and controlled to quality standards.

Compliance with GMP during the production of sterile products.

Investigator Brochure

A compilation of clinical and preclinical data provided to investigators in a clinical trial.

Submission of an investigator brochure to include new safety findings.

New Drug Application (NDA)

Application submitted to request approval for a new pharmaceutical product.

NDA submission for an antiviral medication.

Phrases often used in regulatory documents:

“Meets the criteria for approval”

Indicates that a product or process has satisfied all the necessary evaluation criteria set by regulatory authorities.

The clinical data submitted meets the criteria for approval under Section [specific section] of the regulation.

“In accordance with applicable guidelines”

Confirms that actions or processes comply with regulatory or industry guidelines.

The product’s manufacturing process has been validated in accordance with applicable GMP guidelines.

“As per the requirements of the authority”

Indicates that a particular action follows the directives of a regulatory body.

The label has been updated as per the requirements of the authority and includes all mandated safety warnings.

“Shall comply with”

Specifies a mandatory requirement that must be met.

The company shall comply with all regulatory standards for clinical trials as outlined by the EMA.

“Subject to regulatory approval”

Indicates that an action or decision is dependent on receiving approval from regulatory authorities.

The product launch is subject to regulatory approval from the FDA.

“In accordance with the provisions of”

Refers to compliance with specific sections of a law or regulatory framework.

This submission is made in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act.

“In compliance with”

Confirms that the subject adheres to the applicable laws or regulations.

The product’s labeling is in compliance with 21 CFR Part 201.

“On condition that”

States that approval or a decision is contingent upon specific conditions being met.

Approval for the clinical trial is granted on condition that the sponsor submits updated safety data monthly.

“Provided that”

Introduces a condition that must be fulfilled for something to proceed.

The new labeling is approved provided that all risk warnings are clearly displayed.

“In line with international standards”

Indicates that the action or product adheres to globally recognized guidelines.

The manufacturing process has been audited and found to be in line with international standards such as ISO.

“Pending further evaluation”

Indicates that a final decision is on hold until more data or analysis is provided.

The approval is pending further evaluation of the drug’s long-term safety profile.

“Subject to verification”

Indicates that approval or a decision may be reconsidered based on verification of certain aspects.

The submission is conditionally accepted, subject to verification of the CMC data.

“Shall be subject to”

States that a process or action will undergo further review or constraints as specified.

The final product shall be subject to post-marketing surveillance as per the regulatory guidelines.

“Effective upon receipt of approval”

Indicates that an action will take effect once regulatory approval is granted.

The new dosage recommendations will be effective upon receipt of approval from the authorities.

“In the event of non-compliance”

Explains the consequences or actions that will be taken if there is a failure to comply with regulations.

In the event of non-compliance with these guidelines, corrective measures will be implemented immediately.

“Provided in the applicable regulations”

Refers to requirements established in specific regulatory documents or laws.

The clinical trial design follows the ethical standards provided in the applicable regulations.

“As outlined in the guideline”

Refers to specific guidelines that the document or process adheres to.

The development plan has been structured as outlined in the ICH E6 guideline for Good Clinical Practice.

“Demonstrates conformity with”

Indicates that a submission or action meets specific standards or requirements.

The new drug application demonstrates conformity with the FDA’s requirements for safety and efficacy.

“In accordance with standard operating procedures (SOPs)”

Confirms adherence to internal or external operational procedures for consistency.

The trial was conducted in accordance with standard operating procedures (SOPs) for ethical review and safety.

Types of Regulatory Documents

Clinical Trial Protocols:

Detailed plans that outline how a clinical trial will be conducted.

Regulatory Submissions:

Applications submitted to regulatory bodies, such as Investigational New Drug (IND) applications or New Drug Applications (NDA).

Labelling:

Information provided with a product, including instructions for use, warnings, and ingredients.

Summary Reports:

Documents that summarize the results of studies, trials, or audits.

Key Elements of Regulatory Language

• Clarity and Precision: Each word must be carefully chosen to reflect exact meanings.
• Consistent Terminology: Terms such as "shall," "must," or "may" have distinct legal interpretations and must be used correctly.
• Guideline Adherence: Regulatory language adheres to international standards, such as the International Council for Harmonisation (ICH), the Food and Drug Administration (FDA), or the European Medicines Agency (EMA).

2. Compliance Communication: Conveying Legal and Regulatory Concepts

Compliance communication is about conveying the legal and regulatory requirements in a way that is understandable and actionable within an organization. Unlike regulatory language, which is often formal and legalistic, compliance communication focuses on ensuring that these requirements are clearly understood by employees, contractors, and other stakeholders who need to implement them.

Effective Compliance Communication Strategies

Simplifying Complex Regulations: One of the main challenges in compliance communication is translating the dense, legal language of regulations into clear, practical instructions. For example, a regulation might state that certain practices "must be consistent with good clinical practice (GCP)." It’s the compliance officer's job to explain exactly what that means in everyday operations.

Maintaining a Professional Tone and Structure: While it’s important to make compliance requirements accessible, it’s equally crucial to maintain a professional tone, especially in formal reports or training materials.

Key Focus Areas:

• Policies and Procedures: Every organization must have clear policies and procedures that align with regulatory requirements. Compliance professionals need to write these documents in a way that is both legally sound and easy for employees to follow.
• Training Materials: Compliance training is an ongoing requirement in most regulated industries. These materials must break down complex regulatory requirements into simple, understandable concepts.
• Reports and Audits: Whether for internal purposes or for submission to regulators, compliance reports and audit findings must be detailed and precise. They should also be written in a way that allows readers to understand the context and significance of any findings.

Key Concepts to Communicate

• Adherence to Industry Standards: Standards such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and data privacy regulations (e.g., GDPR) must be clearly communicated. Employees need to understand the specific steps required to meet these standards.
• Risk Mitigation: Compliance communication often focuses on reducing risk, whether it's the risk of non-compliance, product failure, or safety issues. Effective communication helps to identify potential risks and explain how they can be mitigated.

3. Precision and Clarity

Accuracy in both regulatory and compliance communication is not just a matter of good practice; it’s a legal requirement. Regulatory submissions that are unclear or incomplete can lead to delays in product approvals, and miscommunication in compliance can result in legal penalties or product recalls.

Legal and Regulatory Consequences

• Submissions with incorrect or unclear information can lead to rejection or delays from regulatory bodies.
• Poor compliance communication can lead to non-compliance, resulting in fines, sanctions, or damage to an organization's reputation.

Best Practices

• Proofreading and Editing: Given the importance of precision, documents should be carefully proofread to ensure that they are clear and unambiguous.
• Collaboration: Working with legal and regulatory experts can help ensure that communication accurately reflects the latest regulatory requirements and interpretations.

4. Tools and Resources for Improving Regulatory and Compliance Communication

• Glossaries of Regulatory Terms: Developing a glossary of key terms can help teams stay consistent in their use of regulatory language.
• Templates and Examples: Standardized formats for common documents (such as submissions or training materials) can streamline communication and ensure compliance with formatting requirements.
• Training Programs: Language and compliance training can help improve overall communication, particularly for non-native English speakers.

Clear, precise communication ensures that all stakeholders—from regulatory authorities to internal teams—are on the same page, reducing the risk of misinterpretation or delays in approvals. When you can effectively explain complex regulatory requirements, provide concise summaries of progress, and ensure everyone understands their roles, you not only help keep projects on track but also demonstrate leadership and expertise.

By mastering this, you position yourself as a key player, someone who not only understands the technical and legal aspects but can also translate them into actionable insights for diverse teams. Ultimately, this ability makes you indispensable, driving both your projects forward and enhancing your career prospects.

The more effectively you communicate, the more opportunities you unlock, allowing you to move forward with confidence in this ever-evolving field. The decision is yours.