regulatory authorities, healthcare professionals, and patients are aware of the safety profiles of drugs on the market or under investigation.

Why Use MedDRA Terminology?

MedDRA is a clinically validated international medical terminology that serves multiple regulatory purposes. Its principal use is in the classification and reporting of adverse events in clinical trials and post-marketing settings. The adoption of MedDRA terms in PSURs and DSURs offers several benefits:

• Standardization: Using a standardized vocabulary helps maintain consistency across reports, which is essential for clear communication with regulatory agencies.
• Clarity: Employing MedDRA terms allows for precise identification of adverse events, which improves understanding for both regulators and stakeholders.
• Regulatory Compliance: The use of MedDRA is recommended by various regulatory authorities, ensuring that submissions are in line with requirements.

Step 1: Acquiring MedDRA Access

The first step in utilizing MedDRA terms for PSUR/DSUR templates is to acquire access to the MedDRA database. Organizations interested in using MedDRA must register with the MedDRA Maintenance and Support Services Organization ( MSSO). Once registered, organizations can download the latest version of MedDRA, along with associated documentation and guidelines.

Important Note: MedDRA is a controlled vocabulary that requires a license, so ensure compliance with the licensing agreements upon acquiring access.

Step 2: Familiarizing with MedDRA Structure

The MedDRA terminology consists of a hierarchical structure organized by system organ class (SOC), which includes various preferred terms (PT) and sometimes lower-level terms (LLT). Understanding this hierarchy is vital in selecting appropriate terms for reporting in PSURs and DSURs.

The structure can be summarized as follows:

• System Organ Class (SOC): The highest level of classification encompassing related medical conditions.
• Preferred Term (PT): A clinical concept representing a single adverse event or reaction.
• Lower Level Term (LLT): More specific terms that fall under PTs, providing greater detail.

Step 3: Selecting Appropriate MedDRA Terms

With an understanding of MedDRA’s structure, the next step is to select the most relevant terms for your PSUR/DSUR. This process should involve a detailed review of the clinical data, adverse event reports, and other sources of safety information. Here are the steps to guide you in selecting appropriate MedDRA terms:

• Analyze Data: Review reported adverse events and categorize them based on severity, frequency, and relevance.
• Cross-reference Terms: Utilize MedDRA’s search tool to find suitable SOCs, PTs, and LLTs that accurately reflect the clinical findings.
• Verify Consistency: Ensure that the selected MedDRA terms are consistent with previous reports, maintaining continuity in terminology.

Step 4: Integrating MedDRA Terms in PSUR/DSUR Templates

Once MedDRA terms have been selected, the next step is to integrate them into PSUR/DSUR templates. The structure of these reports may vary based on regulatory requirements, but certain key sections typically remain constant. Below is a framework to guide the integration of MedDRA terms:

Sections of PSUR/DSUR Templates

• Introduction: Provide an overview of the medicinal product, including its indication, composition, and marketing authorization status.
• Study Data: Summarize all clinical studies and reported adverse events, employing MedDRA terminology to convey findings.
• Benefit-Risk Evaluation: Conduct an assessment of the benefits versus the reported adverse events utilizing the selected MedDRA terms for clarity.
• Conclusion and Recommendations: Provide actionable recommendations based on the data presented, ensuring that they align with the findings categorized using MedDRA.

When drafting sections, remember to follow any specific formatting and structural guidelines issued by regulatory bodies. The overall goal is to create a document that is easily navigable and comprehensible when reviewed by regulatory authorities.

Step 5: Compliance Considerations

Ensuring compliance with global regulatory standards when preparing PSURs and DSURs is paramount. Companies must be aware of the specific requirements for each market, including the timelines for submission, the frequency of updates, and any regional variations in the use of MedDRA terms. Here are some key compliance considerations:

• Submission Timelines: Regulatory agencies may have specific timelines for PSUR/DSUR submissions, typically ranging from quarterly to annually, depending on the phase of the medication.
• Adverse Event Reporting: Ensure that all serious adverse events are reported accurately, incorporating terms from MedDRA as they pertain to each case.
• Audit and Review Processes: Establish regular audit and review processes for PSUR/DSUR submissions to ensure adherence to internal and external guidelines.

Step 6: Evaluating the Return on Investment (ROI)

Implementing a systematic approach to using MedDRA terms in PSURs and DSURs not only aids compliance but can also yield a significant return on investment for pharmaceutical companies. Evaluating ROI can provide insights into the efficacy of processes and tools in regulatory submissions. Consider the following factors:

• Efficiency Gains: Streamlined processes utilizing MedDRA may reduce the time needed for report preparation, freeing up resources for other critical activities.
• Reduced Non-compliance Risks: Adopting standardized terminology helps mitigate risks of regulatory non-compliance, which can lead to costly fines and delays.
• Enhanced Reputation: Consistently high-quality submissions can enhance a company’s reputation with regulators and in the market, promoting overall trust and credibility.

Final Thoughts

The integration of MedDRA terms in PSUR and DSUR templates is an essential task in the regulatory affairs realm of the pharmaceutical industry. By ensuring compliance, utilizing standardized terminology, and following a structured approach in document preparation, companies can enhance the quality and efficiency of their reporting processes. A robust understanding of MedDRA and its application also strengthens the submission’s alignment with ICH-GCP, FDA, EMA, and other regulatory expectations globally.

For additional information and the latest guidelines in this area, regulatory professionals should consult resources from the International Council for Harmonisation (ICH) and other relevant regulatory bodies.