Pharmacovigilance is crucial for public health, ensuring the safety and effectiveness of medicinal products throughout their lifecycle. It involves periodic evaluation of real-world data to monitor a drug’s safety profile post-market release. Zenovel aims to discuss the evolution of Periodic Safety Update Reports into Periodic Benefit-Risk Evaluation Reports.

Why Ongoing Safety Monitoring Matters

Clinical trials have limitations due to their small, controlled group, exclusion of high-risk populations, and short timeframes. These trials may not reveal rare adverse drug reactions, long-term effects, or risks in diverse patient groups. Real-world data is crucial for identifying these gaps, and PSURs and PBRERs play an essential role in this process. Reports help monitor a drug’s safety and efficacy by analyzing data from broader populations, detecting rare adverse drug reactions (ADRs), evaluating safety in special groups, and assessing long-term impacts, ensuring timely identification and response.

The Birth and Evolution of PSURs

PSURs, introduced in 1992 and standardized by the ICH in 1996, are safety data compilation and evaluation tools for approved drugs. They use clinical trial data, post-marketing safety reports, and Development Safety Update Reports to provide a comprehensive safety overview, aiming to determine if updates to the Reference Safety Information are necessary to reflect new safety findings. The 2012 PBRER, a comprehensive report, aims to balance a drug’s benefits and risks, incorporating clinical trial data, post-marketing surveillance, and risk minimization measures. This approach provides a more comprehensive understanding of a drug’s performance in real-world settings, highlighting the importance of understanding a drug’s risks in the context of its benefits.

The Role of PBRERs in Modern Pharmacovigilance

The PBRERs, a structured format for presenting cumulative data, are a significant advancement in pharmacovigilance practices, as detailed in the ICH’s 2012 guidelines and refined in the EMA’s Good Pharmacovigilance Practices Module 7 (Revision 1, December 2013).

Who Needs PBRERs and When?

The EMA’s EURD list outlines products requiring PBRERs and their submission frequency, ranging from annual to every 16 years. Generic, well-established, homeopathic, or traditional herbal medicines are typically exempt, but authorities may request PBRERs if safety concerns arise. Marketing Authorization Holders (MAHs) must submit PBRERs within 70 days for up to 12 months.

What Do PBRERs Include?

PBRERs aim to deliver a concise yet comprehensive evaluation of a drug’s benefit-risk balance. They include:

• Clinical and Post-Marketing Data: Insights from trials and real-world use.
• Risk Assessment: Identification and analysis of known and potential risks.
• Effectiveness of Risk Minimization: Evaluation of measures taken to reduce risks.
• Benefit-Risk Analysis: A balanced assessment of the drug’s therapeutic value versus its risks.

This multi-faceted approach ensures that regulators and MAHs can make informed decisions about a drug’s continued use or necessary updates to its safety information.

Challenges and Support for Compliance

Pharmacovigilance service providers offer expert support to MAHs, helping them navigate the complexities of PBRER submissions, which vary across regions due to differing timelines, data requirements, and regulatory expectations. They maintain schedules, prepare high-quality PBRERs, and ensure timely submissions to relevant authorities.

The transition from PSURs to PBRERs marks a significant step forward in pharmacovigilance. Shifting the focus from safety alone to a balanced evaluation of benefits and risks. By incorporating real-world data and standardized reporting, PBRERs enhance our ability to protect public health. As pharmacovigilance continues to evolve, these reports remain a vital tool for ensuring that medicines remain safe and effective for all patients.

For MAHs seeking assistance with PBRER preparation, partnering with experienced pharmacovigilance experts can streamline compliance and safeguard product licenses. Contact a Zenovel pharmacovigilance provider today to learn more about managing your PBRER submissions effectively.

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