Pharmacovigilance and technovigilance in Colombia

System and programme

These systems detect and analyse harm from medicines and medical devices already on the market; in Colombia INVIMA coordinates them.

Updated Nov 13, 2026

Key points

Adverse reaction: a harmful, unintended response to a medicine used at usual doses; adverse event: any untoward medical occurrence during treatment, without a proven causal link.
Serious adverse event: causes death, threatens life, causes or prolongs hospital stay, leaves significant disability, causes a congenital anomaly or is otherwise medically important.
Signal: new information about a possible causal link between a medicine and an event; it usually needs more than one report.
Technovigilance (Resolution 4816 of 2008): serious device events and incidents are reported to INVIMA within 72 hours; non-serious ones in quarterly reports.
Industry pharmacovigilance (INVIMA Resolution 2024015321 of 2024, in force since 1 March 2025): holders report serious events within 15 calendar days and non-serious ones within 90.
Causality (WHO-UMC system): from most to least certain, certain, probable, possible and unlikely; most cases fall between probable and possible.

What it is

Pharmacovigilance is the science and activities for detecting, assessing, understanding and preventing adverse events and other medicine-related problems; technovigilance does the same for medical devices as post-marketing surveillance. In Colombia, INVIMA coordinates both national programmes and receives reports from providers, health professionals, manufacturers, importers, marketing authorisation holders and patients. Because clinical trials study few patients for a short time, rare or late reactions appear only once a product reaches thousands of people.

How it is organised

National level: the Ministry of Health and INVIMA, which coordinates the programmes, analyses signals and issues safety alerts.
Departmental and district level: health secretariats, which consolidate reports and follow them up.
Local level: providers with their institutional programme, independent professionals, manufacturers, importers and marketing authorisation holders.
Users: anyone who learns of an event or incident can report it.

Worked example

A made-up hospital receives 48 suspected adverse reaction reports in a year; 12 are serious: 12 / 48 = 25%.
One case: a 60-year-old woman starts an antibiotic and on day three develops a rash, with no other obvious cause.
The antibiotic is stopped and the rash clears within 5 days; it is not given again.
Reasonable timing, no other explanation and improvement on withdrawal: the case is rated probable under the WHO-UMC system.
Reading: without a documented rechallenge the case does not reach ‘certain’; even so, the report adds evidence towards detecting a signal.

Two programmes, one purpose

Aspect	Pharmacovigilance	Technovigilance
Watches	Medicines, including biologicals and herbal products	Medical devices
Reference norm	INVIMA Resolution 2024015321 of 2024 (industry reports)	Resolution 4816 of 2008
Deadline for serious cases	15 calendar days (authorisation holders)	72 hours
Example	Angioedema after starting an antihypertensive	Infusion pump delivering more volume than programmed

Markers

INVIMA
ADR
Serious adverse event
Signal
WHO-UMC

In practice

Reporting does not require certainty: reasonable suspicion is enough; the programme does the causality assessment.
A good report gives the patient's age and sex, the product's generic name and batch, start and stop dates, the outcome and whether the problem returned on restarting.
Besides reactions, therapeutic failures, medication errors and product quality problems are also of interest.
An event after a vaccine is investigated without assuming that the vaccine caused it.

Reference norms

Resolution 4816 of 2008 of the Ministry of Social Protection: regulates the National Technovigilance Programme.
INVIMA Resolution 2024015321 of 2024: content, deadlines and procedures for pharmacovigilance reports; repealed Resolution 2004009455 of 2004.
WHO-UMC system for standardised case causality assessment: the international reference for rating the link between a product and an event.

Test yourself

Think of the answer, then tap the question to see it.

What is the difference between an adverse drug reaction and an adverse event?

An adverse reaction is a harmful response attributed to the medicine; an adverse event is any untoward occurrence during treatment, without a proven causal link.

Which body coordinates pharmacovigilance and technovigilance in Colombia?

INVIMA, together with the Ministry of Health and departmental and district health secretariats.

How soon must a serious adverse event with a medical device be reported?

Within 72 hours, under Resolution 4816 of 2008; non-serious ones go in quarterly reports.

Why does pharmacovigilance find reactions that clinical trials missed?

Because trials include few, selected patients for a short time; rare or late reactions appear once the product is used by thousands of people.

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Connections

← All of epidemiology

Educational content on epidemiological and statistical methods; the examples use made-up numbers to teach the calculation. Not a clinical or legal guide: current Colombian rules are in the official sources.

Sources: Compilación Jurídica del Invima - Resolución 4816 de 2008 MPS (Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia, 2008); Resolución 2024015321 de 2024 INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia, 2024); The use of the WHO-UMC system for standardised case causality assessment (World Health Organization, 2013); Colombia registra más de 10.600 reportes mensuales relacionados con medicamentos: MinSalud e Invima llaman a fortalecer la prevención de riesgos (Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia, 2026).

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Representative model, for educational purposes only.