Introduction to Pharmacovigilance

Pharmacovigilance, a key public health function, involves the process and science of monitoring the safety of medicines and taking action to reduce risks while increasing their benefits. This field is crucial in ensuring the well-being of patients and the general public by identifying, evaluating, and preventing adverse effects or any other drug-related problems.


The European Union’s Approach

The European Union (EU) has one of the most advanced and comprehensive pharmacovigilance systems globally. This system ensures a high level of public health protection across the EU by monitoring the safety of medicines on the market. Key activities include:

  • Collecting and managing data on medicine safety.
  • Detecting “signals” of new or changing safety issues.
  • Evaluating data and making decisions regarding safety issues.
  • Implementing proactive risk management.
  • Acting to protect public health, including regulatory action.
  • Communicating with stakeholders and the public.
  • Auditing outcomes and key processes.

The Role of the World Health Organization (WHO)

The WHO plays a pivotal role in promoting global medicinal product safety through its Programme for International Drug Monitoring (PIDM). This program sets worldwide pharmacovigilance standards and systems and coordinates global networks for monitoring, assessing, and preventing adverse drug reactions (ADRs) and other medicine-related issues. The WHO also focuses on countering misinformation about vaccines through the Vaccine Safety Net (VSN) and developing training programs to strengthen national safety surveillance systems.

Pharmacovigilance in the Americas

The Pan American Health Organization (PAHO) emphasizes the importance of pharmacovigilance in ensuring that the benefit-risk ratio of medicines remains favorable throughout their lifecycle. Objectives of pharmacovigilance in the Americas include:

  • Improving patient care and safety in relation to medicine use.
  • Enhancing public health and safety.
  • Detecting and communicating medicine-related problems.
  • Contributing to the assessment of medicines’ benefit-risk ratio.
  • Promoting the safe, rational, and cost-effective use of medicines.
  • Encouraging education and training in pharmacovigilance.

PAHO also supports guidelines and recommendations on safe medicine use, provides technical cooperation with national medicine safety surveillance systems, and promotes studies and innovative tools for medicine safety.

Legal Framework and Regulatory Actions

The legal framework for pharmacovigilance in the EU is outlined in Regulation (EC) No 726/2004 and Directive 2001/83/EC. These regulations cover EU authorized medicinal products and nationally authorized products, respectively. Additionally, the Black Symbol initiative identifies medicines under additional monitoring, encouraging healthcare professionals and patients to report unexpected adverse reactions.

Challenges and Future Directions

Pharmacovigilance faces challenges such as underreporting of ADRs and the need for continuous adaptation to emerging health threats, like the COVID-19 pandemic. Future directions involve enhancing global collaboration, improving reporting systems, and integrating new technologies and methodologies to better detect and assess drug safety issues.


Pharmacovigilance is an essential aspect of healthcare, playing a critical role in ensuring the safety and efficacy of medicines. Through international collaboration, robust legal frameworks, and continuous monitoring and assessment, pharmacovigilance helps in maintaining a favorable benefit-risk balance of medicines, ultimately safeguarding public health.

Note: This chapter is based on information from the European Commission’s Public Health website, the World Health Organization, and the Pan American Health Organization. For more detailed and specific information, please refer to the original sources.


  1. European Commission. Pharmacovigilance [Internet]. Brussels: European Commission; [cited 2023 Nov 19]. Available from:
  2. World Health Organization. Pharmacovigilance [Internet]. Geneva: WHO; [cited 2023 Nov 19]. Available from:
  3. Pan American Health Organization. Pharmacovigilance [Internet]. Washington, D.C.: PAHO; [cited 2023 Nov 19]. Available from:

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