Resources for
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Pharmacovigilance: a shared responsibility
Clearing Doubts
Frequently Asked Questions
Clearing Doubts
Frequently Asked Questions
What are the ICH pharmacovigilance guidelines?
The ICH Guidelines (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) are a set of standards and recommendations designed to ensure the quality, safety, and efficacy of medicines, including aspects of pharmacovigilance.
What is the main objective of the ICH pharmacovigilance guidelines?
How many guidelines currently address pharmacovigilance activities?
There are six guidelines distributed as follows:
Essential Manuals and Guidelines for Pharmacovigilance
ICH Guidelines
GOOD PHARMACOVIGILANCE PRACTICES.
Risk Management Plans
Importance of Risk Management Plans Associated with Medicines
Ensuring Benefit-Risk Ratio
Plans ensure that the benefits of a medicine outweigh the associated risks, keeping patient safety as a priority.
Continuous Safety Monitoring
They allow for constant monitoring of the medicine's safety, identifying and managing adverse effects throughout its lifecycle.
Improvement in Risk Communication
They facilitate effective risk communication to healthcare professionals and patients, improving informed decision-making.
Regulatory
Compliance
They ensure compliance with national and international regulations, maintaining high standards in the pharmaceutical industry.
Collaboration Among Stakeholders
They promote collaboration among healthcare professionals, regulators, and the pharmaceutical industry for more effective and coordinated risk management.
This Pharmacovigilance site does not collect Adverse Drug Reaction Reports.
If you wish to report an adverse effect or technical complaint regarding a pharmaceutical product, please contact your healthcare provider and/or the Health Authorities in your respective country.