Pharmacovigilance Requirements in Colombia

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Pharmacovigilance Requirements in Colombia

Pharmacovigilance Requirements in Colombia – CRO Partner

Pharmacovigilance is a cornerstone of drug regulation and patient safety, aimed at detecting, assessing, and preventing adverse effects or any other drug-related issues. In Colombia, like in many countries, pharmacovigilance is a crucial component of the healthcare system, ensuring that pharmaceutical products remain safe and effective throughout their lifecycle.

This blog delves into the pharmacovigilance requirements in Colombia, shedding light on the regulatory framework, reporting obligations, and the significance of robust pharmacovigilance practices.

Regulatory Landscape

The surveillance and monitoring of pharmaceutical products in Colombia are overseen by the National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA). INVIMA is the regulatory authority responsible for setting the guidelines and regulations that govern the pharmacovigilance activities carried out by pharmaceutical companies, healthcare professionals, and marketing authorization holders.

Key Pharmacovigilance Activities

  1. Adverse Event Reporting: One of the primary pharmacovigilance requirements in Colombia is the prompt reporting of adverse events to INVIMA. Pharmaceutical companies and marketing authorization holders are obligated to report any adverse event that occurs within the country, including unexpected or severe adverse reactions, to ensure the ongoing assessment of a product’s safety profile.
  2. Periodic Safety Reports: Pharmaceutical companies are required to submit Periodic Safety Reports (PSRs) to INVIMA. These reports provide a comprehensive overview of the safety profile of a drug, including any emerging safety concerns, changes to product information, and a summary of adverse events reported during a specified timeframe.
  3. Risk Management Plans (RMPs): Certain high-risk drugs may necessitate the submission of Risk Management Plans to INVIMA. These plans outline strategies and measures for identifying, characterizing, and managing the risks associated with the drug. RMPs are particularly relevant for drugs with complex safety profiles or those intended for specific patient populations.
  4. Signal Detection and Evaluation: INVIMA conducts signal detection and evaluation activities to identify potential safety signals associated with marketed drugs. By analyzing data from various sources, including adverse event reports and scientific literature, INVIMA can detect emerging safety concerns that require further investigation.
  5. Communication of Safety Information: Pharmaceutical companies are responsible for disseminating updated safety information to healthcare professionals and patients. This includes updating product labeling and package inserts to reflect new safety findings or changes in the risk-benefit profile of the drug.

Pharmacovigilance Requirements in Colombia

Pharmacovigilance Requirements in Colombia

Pharmacovigilance Requirements in Colombia

Importance of Robust Pharmacovigilance

Effective pharmacovigilance practices in Colombia serve several critical purposes:

  1. Patient Safety: The foremost objective of pharmacovigilance is to ensure patient safety by swiftly identifying and addressing any adverse effects or safety concerns linked to pharmaceutical products. This commitment to patient well-being builds trust in the healthcare system.
  2. Regulatory Compliance: Adhering to pharmacovigilance requirements is essential for regulatory compliance. Failure to report adverse events or provide timely safety updates can lead to regulatory actions, including product recalls or the suspension of marketing authorization.
  3. Continuous Benefit-Risk Assessment: Pharmacovigilance facilitates an ongoing assessment of the balance between a drug’s benefits and risks. This information empowers informed decisions about the continued marketing and usage of pharmaceutical products.
  4. Global Collaboration: Adverse events and safety concerns transcend national borders. Effective pharmacovigilance practices enable collaboration and information sharing with international regulatory bodies, fostering a global understanding of drug safety profiles.


Pharmacovigilance stands as a cornerstone of drug safety and public health in Colombia, ensuring the well-being of patients and the integrity of pharmaceutical products. The regulatory framework established by INVIMA lays out clear guidelines for adverse event reporting, safety updates, and risk management strategies.

Adhering to these requirements not only safeguards patient health but also ensures regulatory compliance and upholds the standards of the pharmaceutical industry. As pharmacovigilance continues to evolve, its emphasis on safety remains pivotal to Colombia’s healthcare landscape and the betterment of patients’ lives.

Pharmacovigilance Requirements in Colombia

Source: Pro Colombia

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Pharmacovigilance Requirements in Colombia

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Pharmacovigilance Requirements in Colombia

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Pharmacovigilance Requirements in Colombia

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Colombia &

Daniela Maresca
Daniela Maresca | Country Lead Argentina
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Pharmacovigilance Requirements in Colombia

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Pharmacovigilance Requirements in Colombia

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Pharmacovigilance Requirements in Colombia

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