Regulatory Medical Writing in 2025: Global Compliance, Clarity, and Control

Regulatory writing and medical writing are closely related but differ in terms of responsibilities, target audiences, and expertise. Regulatory medical writing is a specialized subset of medical writing and plays a critical role in supporting regulatory submission during pharmaceutical research and development (R&D) for regulatory review and approval, as well as for communication with stakeholders. Regulatory writers prepare a range of documents, from investigational new drug applications (INDs) to clinical study reports. This blog highlights the importance of regulatory writing, key global regulatory differences, and the main types of regulatory documents.  We also outline the best practices for regulatory document preparation and explore how outsourcing professional regulatory medical writing services ensures consistent, quality, and accelerated submissions. 

Global Regulatory Differences: FDA vs. EMA vs. PMDA

Effective regulatory medical writing requires navigating and adapting to different regulatory bodies. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Device Agency (PMDA) all share the same goals in ensuring therapies are high quality, safe, and efficacious, although their processes, requirements, and organizational structures differ. 

Regulatory Approval Pathways and Documentation

FDA Approval Pathway - Uses INDs, New Drug Applications (NDAs), and Biologics License Applications (BLAs) for approvals. Extensive Chemistry, Manufacturing and Controls (CMC) data is required upfront.

EMA Approval Pathway - Uses Marketing Authorization Applications (MAAs) and requires a comprehensive quality dossier as part of the submission. It may also require a Pediatric Investigation Plan (PIP).

PMDA Approval Pathway - Focuses on national approval processes and often requires local clinical data to include relevant data for the Japanese population. 

H3: Clinical Trial Requirements

FDA Clinical Trial Requirements - Clinical trials must emphasize racial diversity to reflect the U.S. population.

EMA Clinical Trial Requirements - Regulated clinical trials must comply with the General Data Protection Regulation (GDPR). 

PMDA Clinical Trial Requirements - Prioritizes the inclusion of Japanese participants in clinical trials.

H3: Specialist Programmes

FDA - Fast Track, Breakthrough Therapy, Accelerated Approval for expedited access. 

EMA - PRIME scheme for priority medicines.

PMDA - Sakigake Designation for innovative therapies.

Key Document Types in Regulatory Medical Writing

FDA INDs and NDAs

Both INDs and NDAs are submitted to the FDA. An IND is an essential part of the R&D process, where a request is submitted for permission to conduct clinical trials of a new drug or biologic in humans. Gaining IND approval allows for essential research where the safety and efficacy of a new drug can be assessed before it can be marketed. Whereas, an NDA is the formal application to the FDA to market a new small molecule drug.

FDA BLAs and MAAs

Both BLAs and MAAs are crucial for gaining regulatory approval to market a therapeutic. A BLA is submitted to the FDA and is specific for biologics, including monoclonal antibodies, and cell and gene therapies. An MAA is targeted specifically to the EMA for approval of medicinal products to the EU and associated countries.

Electronic submission requirements - Electronic Common Technical Document (eCTD) format

The eCTD format is an essential electronic submission requirement for regulatory submissions,  ensuring standardization and efficiency in the review process. The eCTD is the standard electronic format for submitting regulatory information, a requirement for almost all regulatory submissions to the FDA and EMA. The eCTD format is primarily based on the Common Technical Document (CTD) and uses an XML backbone, ensuring accuracy and efficiency.

Specific regulatory pathways - 505(b)(2) and orphan drug designation

The 505(b)(2) and orphan drug designation are specific regulatory pathways within the FDA for drug development and approval. The 505(b)(2) aims to streamline the approval process for previously approved drugs that have been modified or are seeking approval for a new use. This generally speeds up the application timeline, as previously approved data can be used to support the application, reducing the need for new, extensive clinical trials. However, evidence that the new use or modified drug is safe and efficacious is still required. An orphan drug designation is aimed at encouraging the development of therapeutics for rare diseases.

Best Practices for Regulatory Document Preparation

Effective scientific communication is essential in regulatory medical writing. Ensuring regulatory documents are prepared to the highest standards helps build credibility with stakeholders and increases the likelihood of regulatory approval. Some of the best key practices for regulatory document preparation include:

• Clarity and precision: Using clear, concise language and defined terminology ensures that regulatory documents are easily understood by reviewers. 

• Compliance with guidelines: Ensuring specific guidelines from the FDA, EMA, and PMDA are followed. This includes consistent and correct formatting, structure, and content. 

• Accuracy and completeness: Ensure all information in the document is accurate, verifiable, and supported by data.

• Data integrity: Ensure all data is attributable, legible, contemporaneous, original, and accurate (ALCOA principles).
  

Regulatory Writing Services

Outsourcing regulatory writing can ensure that submission documents are at the highest standard and quality for submission. Expert regulatory writers can prepare clinical study protocols, clinical study reports, investigator brochures, non-clinical and safety documents, and write regulatory submissions such as INDs, NDAs, and MAAs. They also offer editing and formatting services, increasing confidence and accuracy in regulatory submissions. 

Benefits of Outsourcing Regulatory Writing

Outsourcing regulatory medical writing services has multiple advantages, including:

• Time savings: Freeing up time for internal team members to dedicate to core R&D. Ensuring documentation is correct the first time, avoiding reworks, and accelerating approval timelines.

• Expertise and Compliance: Regulatory writers have deep knowledge and expertise in regulatory guidelines, ensuring documents are accurate, clear, and compliant. 

• Efficiency: Streamlines and accelerates the process and burden on internal staff members. 

• Quality assurance: Expert regulatory writers can provide quality checks to detect any inconsistencies and errors, improving the accuracy of regulatory documents and accelerating turnaround times.

  
  

Conclusion

Regulatory medical writing can seem complex, especially when complying with the requirements of multiple regulatory bodies such as the FDA, EMA, and PMDA. Ensuring that documents are accurate and adhere to each authority’s guidelines can be challenging. However, by outsourcing regulatory medical writing, this simplifies submission processes, ensuring adherence to global regulatory requirements, whilst accelerating timelines without compromising quality.

At Co-Labb, our PhD-educated writers bring extensive experience in regulatory writing. Whether you're preparing an IND, a clinical study report, or any other regulatory documentation, we’re here to support you at every stage. Contact us today to ensure your submissions are compliant, clear, and delivered to the highest standard.