After the United States Food and Drug Administration (US FDA)’s guidance document, titled ‘Integrated Summaries of Safety and Effectiveness (ISS/ISE): Location Within the Common Technical Document, was released in April 2009, the significance of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) increased. ISS and ISE are pre-approval Regulatory submission documents for new drugs and biologics. They are clinical reports that are part of Module 5.3 during the electronic Common Technical Document (eCTD) submission to support the products’ safety and effectiveness. However, preparing the submissions can be complex and time-consuming and requires significant expertise in Regulatory medical writing. Hence, an experienced Regulatory medical writer is crucial in preparing high-quality and compliant ISS and ISE submissions.

The Role of a Regulatory Medical Writer in Preparing Compliant ISS and ISE Submissions:

Compliant ISS and ISE submissions can be achieved through a qualified medical writer with the following qualities:

  • Data Organization and Management: A medical writer needs to organize and manage clinical trial data or clinical trial summaries from various sources. The step should ensure that the data is analyzed in a Regulatory-compliant manner.
  • In-depth Understanding of Health Authority (HA) guidelines: A medical writer should guide the organization regarding relevant regulations, guidelines, and best practices related to ISS and ISE submissions.
  • Quality Resilience: A medical writer needs to perform Quality Assurance (QA) checks to ensure completeness, accuracy, and quality. They can also provide recommendations for improving the submissions, if necessary.
  • Cross-functional Team Collaboration: A medical writer must seek inputs from various stakeholders across the Regulatory domain. Collaboration ensures error-free, complete, and clinically aligned submissions to HAs.
  • Upholding Consistency: A medical writer should ensure consistency of format and style throughout the submission document.
  • Striving for Continuous Improvement in the Process: A medical writer is responsible for continuously improving the quality of ISS and ISE drafts.
  • Risk Management: A medical writer is involved in identifying and mitigating any risks associated with the data presented in the ISS and ISE sections of the New Drug Application (NDA) and Biologics License Application (BLA) submissions to HAs.

Benefits of Hiring a Regulatory :

Hiring a Regulatory can offer several benefits to pharmaceutical companies. The following are some of the listed benefits:

  • On-demand Expertise: A medical writer has a deep understanding of Regulatory guidelines and requirements, which helps avoid cost-intensive mistakes and delays in the drug development process.
  • Accuracy: A medical writer ensures that the ISS and ISE documents are accurate and complete, which in turn prevents HAs from rejecting the submitted applications on the grounds of data deficiency.
  • Efficiency: A medical writer works in close association with the clinical research team to gather and analyze the data, which in turn helps streamline the drug development process. Such collaboration ensures efficiency right from the fundamental stages, leading to foolproof ISS and ISE drafts.

Pharmaceutical companies often face challenges with ISS and ISE submissions, which include data unavailability, non-compliant study designs, lack of data harmonization, and QA oversight, all of which may cause errors, leading to submission delays. Having an experienced Regulatory partner will ensure that the submissions are error-free and prepared in time.

In a nutshell, ISS and ISE submissions form a critical part of pre-approval Regulatory submissions for new drugs and biologics. Drafting foolproof ISS and ISE for HA submissions can be complex and require significant expertise in Regulatory writing. By leveraging the expertise of forty (40)+ clinical and non-clinical experts, including scientific writers, we can make your ISS and ISE submissions a hassle-free endeavor. Consult Freyr and ensure compliance throughout your Regulatory journey!


Varunesh Sanjay Tambe


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