What is Pharmacovigilance?
Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and / or unexpected. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use. However, the clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time. Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period of time.
The WHO PIDM in Focus - Building a global community
Vaccines, thimerosal and autism spectrum disorder
The Global Advisory Committee on Vaccine Safety (GACVS) reviewed the evidence regarding a potential link between vaccines and autism multiple times between 2002 and 2012, consistently concluding that the evidence does not support a causal relationship. To provide an updated and comprehensive overview of the published scientific literature on this topic, the WHO commissioned a review of studies from 2010 to 2025.
WHO Risk Management Plan Assessment Workshop in Uganda for the Uganda National Drug Authority, from 10–12 November 2025 in Kampala
The WHO Pharmacovigilance (PVG) Team, in collaboration with the Paul-Ehrlich-Institut (PEI, Germany), held a hands-on RMP and PSUR Assessment Workshop for the Uganda National Drug Authority (NDA) from 10–12 November 2025 in Kampala.
The workshop strengthened NDA’s capacity to review Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) using the WHO Model Assessment Tools, focusing on safety specifications, pharmacovigilance planning, and risk-minimization measures for high-priority vaccines and medicines.
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To support Uganda’s preparation for introducing arPraziquantel—the first global rollout of the paediatric formulation—the EMA-approved RMP for arPraziquantel was used in practical exercises. Participants also worked with RMPs and PSURs of key vaccines to apply the tools across different product types.
Assessors from Market Registration and Pharmacovigilance participated in group assessments of major RMP and PSUR sections, presenting findings, identifying safety concerns, and proposing context-appropriate risk-minimization measures.
WHO Programme for International Drug Monitoring (PIDM) meeting
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The 43rd Annual Meeting of the members of the WHO Programme for International Drug Monitoring (PIDM) was held in Cairo, Egypt (27-29 Oct 2025) with the theme ‘Pharmacovigilance in women of childbearing potential and children’.
Participants from around the world discussed this theme in the context of the WHO Global Smart Pharmacovigilance Strategy.
National workshop on VigiMobile introduction in Eritrea
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The World Health Organization Pharmacovigilance Team (WHO-PVG), in collaboration with the Uppsala Monitoring Centre (UMC), Sweden, facilitated a national workshop on VigiMobile introduction, a Smart-phone application tools for reporting Adverse Events Following Immunization (AEFI) and Adverse Drug Reactions (ADR) at Asmara, Eritrea on14–15 October 2025. The training brought together over 60 participants, including national and zonal pharmacovigilance focal points, regulatory affairs officers, representatives from the Expanded Programme on Immunization, and specialists in Information and Communication Technology. VigiMobile will enable the transition from paper-based reporting to a streamlined, digital system, thereby enhancing the efficiency, accuracy, and timeliness of adverse events reporting in the country.
Workshop on the Assessment of Risk Management Plans, WHO, Geneva, 3 – 4 June 2025
The WHO Pharmacovigilance team (PVG), in close collaboration with the Paul-Ehrlich-Institut (PEI), Germany, hosted a workshop on Risk Management Plan (RMP) Assessment at WHO headquarters, Geneva, from 3 to 4 June 2025. Assessors from four African National Regulatory Authorities representing the departments of product registration and pharmacovigilance from Ghana, Rwanda, Sierra Leone and Zimbabwe participated.
The workshop introduced the Model RMP Assessment Tools developed by WHO PVG and provided an opportunity to pilot these and receive feedback from the countries based on their practical application, with the goal of refining and finalizing the tools.
VigiMobile training in Uganda
The WHO Pharmacovigilance Team, in collaboration with the Uppsala Monitoring Centre, Sweden, facilitated a national training on the VigiFlow and VigiMobile tools on 22-23 May 2025 for over 50 vaccine safety focal points at Entebbe, Uganda. Participants included representatives from the Uganda National Regulatory Authority, Immunization Program, regional referral hospitals, and the WHO Country Office.
This training marks another significant milestone in WHO’s ongoing efforts to support low- and middle-income countries in strengthening electronic reporting of vaccine safety events. The adoption of these tools enables more efficient, accurate, and timely data capture and transmission from the field to national systems. It also ensures that critical safety data are simultaneously accessible to both national regulators and immunization programs.
Moreover, the improved speed and accuracy of data flow contribute to faster submission of safety information to the WHO global safety database, reinforcing global pharmacovigilance efforts.
WHO Pharmacovigilance Partners’ Meeting
A WHO Pharmacovigilance Partners’ Meeting was organized on 13 October 2024 in New Delhi, India on the margins of the 19th International Conference of Drug Regulatory Authorities (ICDRA). 147 people from 68 countries participated in this face-to-face meeting, to review the WHO Global Smart Pharmacovigilance Strategy. A synopsis of the draft Strategy is available. The revised Strategy will be available in the coming months.
About us
The WHO Pharmacovigilance team strives to ensure safer use of medicines and vaccines throughout the life cycle of the products. We produce reliable, balanced information on the benefits and risks of medicines and vaccines, which enhances people’s care and safety.
Team Lead: Dr Shanthi Pal
Among our activities we are:
- Developing norms, standards and guidelines.
- Providing credible safety and regulatory information on medicines.
- Appointing and convening global advisory committees of experts to review and provide guidance on the safety of medicines and vaccines.
- Hosting global networks such as the WHO Programme for International Drug Monitoring (PIDM) to promote pharmacovigilance in countries.
- Establishing and maintaining WHO Collaborating centres (WHO CCs) to provide technical support to countries in pharmacovigilance.
- Countering vaccine-misinformation about vaccines through the Vaccine Safety Net (VSN), which facilitates the access to reliable information on vaccine safety.
- Providing training programmes to build and strengthen the capacity of national safety surveillance systems for medicines and vaccines .
- Developing innovative methods and tools to generate new evidence on the safety of medicinal products