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# 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.

On this page

- The basics Key points
- What it is
- How it is organised
- Worked example
- Two programmes, one purpose
- Markers
- In practice
- Reference norms
- Memory aid

- Study Test yourself

- Connections Connections

## 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.

## Memory aid

Pharma for drugs, techno for devices: both keep watch after sale, when thousands are exposed.

## 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

## Related 6

- [Patient safety and adverse events](https://durgical.com/en/epidemiology/patient-safety-and-adverse-events/)
- [Phases of clinical trials](https://durgical.com/en/epidemiology/phases-of-clinical-trials/)
- [Real-world evidence and comparative effectiveness](https://durgical.com/en/epidemiology/real-world-evidence-and-comparative-effectiveness/)
- [Public health surveillance](https://durgical.com/en/epidemiology/public-health-surveillance/)
- [Case report and case series](https://durgical.com/en/epidemiology/case-report-and-case-series/)
- [Number needed to harm](https://durgical.com/en/epidemiology/number-needed-to-harm/)

[← All of epidemiology](https://durgical.com/en/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](https://normograma.invima.gov.co/compilacion/docs/resolucion_minproteccion_4816_2008.htm) (Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia, 2008); [Resolución 2024015321 de 2024 INVIMA](https://normograma.invima.gov.co/normograma/compilacion/docs/resolucion_invima_15321_2024.htm) (Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia, 2024); [The use of the WHO-UMC system for standardised case causality assessment](https://www.who.int/publications/m/item/WHO-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](https://www.invima.gov.co/blog/sala-de-prensa-13/colombia-registra-mas-de-10-600-reportes-mensuales-relacionados-con-medicamentos-minsalud-e-invima-llaman-a-fortalecer-la-prevencion-de-riesgos-639) (Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia, 2026).

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License: CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/). Cite as: DurgiPedia (durgical.com), https://durgical.com/en/epidemiology/pharmacovigilance-and-technovigilance-in-colombia/