Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 – 27 November 2025 – European Medicines Agency

PRAC Monthly Meeting Report: Upholding Sustainable Development Goals in Pharmaceutical Safety

Commitment to SDG 3: Good Health and Well-being

The Pharmacovigilance Risk Assessment Committee (PRAC) convened for its monthly meeting, reinforcing its commitment to ensuring public health and safety, a cornerstone of Sustainable Development Goal 3. The committee’s work is integral to achieving Target 3.8 by guaranteeing access to safe, effective, and quality medicines. Key activities undertaken during this session to support this goal included:

• Comprehensive Assessment of Safety Signals: Proactive identification and evaluation of potential adverse effects of medicines to protect patient health.
• Systematic Review of Risk Management Plans: Ensuring robust strategies are in place to mitigate known and potential risks associated with medicinal products.
• Evaluation of Periodic Safety Update Reports (PSURs): Continuous monitoring of the benefit-risk balance of medicines once they are on the market.
• Oversight of Post-Authorisation Safety Studies (PASS): Scrutinizing data from real-world use to further understand a medicine’s long-term safety profile.

Enhancing Institutional Transparency and Partnerships (SDG 16 & SDG 17)

In line with SDG 16 (Peace, Justice and Strong Institutions) and SDG 17 (Partnerships for the Goals), the PRAC maintains a transparent and accountable operational framework. This approach fosters trust and collaboration among stakeholders, which is essential for a resilient global health system. Procedural updates from the meeting that reflect this commitment include:

1. Referral Procedure Status: It was confirmed that no new referral procedures were initiated or concluded during this session, providing stability and clarity in the regulatory process.
2. Information Accessibility: Details regarding ongoing safety referrals remain publicly accessible in a dedicated table, ensuring all stakeholders are informed of continuing assessments.
3. Agenda Transparency: The full agenda detailing all topics discussed by the committee is available for public review, underscoring the PRAC’s dedication to open and effective governance as a strong institution.

Analysis of Sustainable Development Goals in the Article

Which SDGs are addressed or connected to the issues highlighted in the article?

1. SDG 3: Good Health and Well-being

   • The article discusses the work of the European Medicines Agency’s (EMA) safety committee (PRAC), whose responsibilities “cover all aspects of the risk management of the use of medicines.” This function is central to ensuring public health by making sure that medicines are safe for consumption, which directly aligns with the overall goal of promoting well-being and healthy lives.

What specific targets under those SDGs can be identified based on the article’s content?

1. Target 3.8: Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.

   • The article highlights the PRAC’s role in the “assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.” These activities are crucial mechanisms to ensure that medicines on the market are safe, effective, and of high quality, which is a key component of this target.

2. Target 3.d: Strengthen the capacity of all countries, in particular developing countries, for early warning, risk reduction and management of national and global health risks.

   • The committee’s core responsibility is described as “risk management of the use of medicines.” This involves identifying potential health risks through safety signals and managing them proactively. This work directly contributes to strengthening the capacity for risk reduction and management of health risks associated with pharmaceuticals on a large scale.

Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

• The provided article does not contain any specific, measurable indicators to track progress towards the identified targets. It is a high-level summary of the committee’s responsibilities and meeting topics. While it mentions activities like “assessment of safety signals” and “risk management plans,” it does not provide any quantitative data, such as the number of assessments conducted, the reduction in adverse drug events, or other metrics that could serve as indicators. The statement that the committee “did not start or conclude any referral procedures” is a qualitative status update rather than a recurring performance indicator.

SDGs, Targets, and Indicators Summary

Source: ema.europa.eu