INVIMA (Colombia)

INVIMA (the Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is the Republic of Colombia's national regulatory authority responsible for the regulation of human + veterinary medicines + biologicals + vaccines + medical devices + IVDs + cosmetics + food + dietary supplements + cleaning products + tobacco-related products. INVIMA was established by Law 100 of 1993 (Article 245) + Decree 1290 of 1994 as part of Colombia's foundational health-system reform creating the Sistema General de Seguridad Social en Salud (SGSSS). INVIMA is structured as a public scientific + technical establishment with administrative + financial autonomy + national jurisdiction, reporting to the Ministry of Health and Social Protection (MinSalud).

INVIMA's organisational structure includes:

• Director General — chief executive appointed by Presidential Decree on Ministerial recommendation; serves at the discretion of the Executive.
• Sub-Director General — deputy chief executive supporting strategic + operational management.
• Dirección de Medicamentos y Productos Biológicos — medicines + biologicals + biosimilars + vaccines registration + Sala Especializada de Medicamentos y Productos Biológicos.
• Dirección de Dispositivos Médicos y Otras Tecnologías — medical devices + IVDs + other health technologies registration + classification.
• Dirección de Alimentos y Bebidas — food + beverages + dietary supplements registration + food safety + Sala Especializada de Alimentos y Bebidas.
• Dirección de Cosméticos, Aseo, Plaguicidas y Productos de Higiene Doméstica — cosmetics + cleaning + pesticide + household-hygiene products + Sala Especializada de Productos de Higiene + Cosméticos.
• Dirección de Operaciones Sanitarias — port-of-entry operations + inspections + enforcement + counterfeit-product investigation.
• Dirección de Responsabilidad Sanitaria — administrative enforcement + sanctions + legal proceedings.
• Dirección General de la Red Nacional de Laboratorios — National Laboratory Network coordination + INVIMA Laboratorio in Bogotá + departmental laboratory coordination.
• Grupos Técnicos — specialist technical groups for Farmacovigilancia + Reactivovigilancia + Tecnovigilancia + Cosmetovigilancia + Sala Especializadas.

INVIMA operates a network of Salas Especializadas (Specialised Chambers) — INVIMA's distinctive technical-scientific advisory body model. Each Sala Especializada is a panel of external scientific experts + INVIMA staff that provides binding technical opinions on registration applications + classification decisions + product safety + complex regulatory questions. The Sala Especializada model includes the Sala Especializada de Medicamentos y Productos Biológicos (SEMPB), Sala Especializada de Reactivos de Diagnóstico In Vitro (SERDIV), Sala Especializada de Dispositivos Médicos y Productos Varios (SEDMPV), Sala Especializada de Alimentos y Bebidas (SEAB), Sala Especializada de Productos de Higiene Doméstica y Cosméticos (SEPHDC) + others. The Sala Especializada decisions are recorded in formal Actas (Minutes) published on INVIMA's website + are binding technical input to INVIMA registration decisions.

INVIMA is distinct from + complementary to: ICA (Instituto Colombiano Agropecuario, regulating veterinary medicines + agricultural inputs + animal-origin foods); ANLA (Autoridad Nacional de Licencias Ambientales, environmental licensing including for pharmaceutical manufacturing); the Superintendencia Nacional de Salud (Supersalud, regulating health-insurance + health-service-delivery quality); the Comisión Nacional de Precios de Medicamentos y Dispositivos Médicos (CNPMDM, pharmaceutical pricing); + the Colegios de Farmacéuticos (provincial pharmacy professional bodies).

Legal foundations are Law 100 of 1993 (creating SGSSS + INVIMA), Decree 1290 of 1994 (operational establishment of INVIMA), Decree 677 of 1995 (current medicines regulatory framework), Decree 4725 of 2005 + Resolution 4002 of 2007 (medical devices + IVDs), Decree 3554 of 2004 + Resolution 3823 of 2013 (cosmetics + personal hygiene), Resolution 3157 of 2018 (current Colombian GMP), Decree 3075 of 1997 (food sanitary regulation) + Resolution 2674 of 2013 (current food GMP) + a substantial body of INVIMA Circulars + technical guidelines.

INVIMA is a WHO/PAHO Regional Reference Authority for the Americas — originally designated in 2011 + re-confirmed in 2021 under the updated PAHO regulatory-system benchmarking. INVIMA is a WHO Listed Authority + an active WHO Prequalification Collaborative Registration Procedure (CRP) Reference Authority + an IMDRF Affiliate Member + a PIC/S Applicant. INVIMA is a co-leader of the Andean Community (Comunidad Andina, CAN) Pharmaceutical Harmonisation framework alongside ARCSA Ecuador + DIGEMID Peru + AGEMED Bolivia + an active PANDRH (Pan American Network for Drug Regulatory Harmonisation) participant alongside FDA + Health Canada + ANVISA + COFEPRIS + ANMAT.

Colombian pharmaceutical regulation operates under a layered framework of primary legislation + INVIMA Resolutions + Circulars:

• Law 100 of 1993 — foundational SGSSS health-system reform; Article 245 creates INVIMA.
• Decree 1290 of 1994 — operational establishment of INVIMA as scientific + technical public establishment.
• Decree 677 of 1995 — current Colombian medicines regulatory framework covering manufacture, importation, marketing authorisation, pharmacovigilance + post-market surveillance.
• Decree 549 of 2001 + Decree 162 of 2004 — biosimilars + biotechnology-derived medicines framework.
• Decree 2200 of 2005 — pharmacy practice regulation (administered jointly with provincial Colegios de Farmacéuticos).
• Decree 4725 of 2005 — medical devices + IVDs regulatory framework with Class I-III risk-based classification.
• Resolution 4002 of 2007 — INVIMA medical-device + IVD technical guidelines.
• Decree 3554 of 2004 — cosmetics regulatory framework substantively aligned with Andean Community Decision 516.
• Resolution 3823 of 2013 — INVIMA cosmetics technical guidelines + cosmetovigilance.
• Resolution 3157 of 2018 — current Colombian Good Manufacturing Practice Guidelines substantively aligned with PIC/S GMP Guide + EU GMP + ICH Q7 + WHO TRS 986 Annex 2.
• Decree 3075 of 1997 + Resolution 2674 of 2013 — food sanitary regulation + food GMP.
• Decree 3249 of 2006 — dietary supplements framework.
• Resolution 1403 of 2007 — INVIMA technical guidelines on dietary supplements + nutraceuticals.
• Resolution 3692 of 2018 — current INVIMA pharmacovigilance framework substantively aligned with ICH E2 + EU GVP.
• Resolution 4396 of 2019 — current INVIMA Good Clinical Practice + Clinical Trial Authorisation framework substantively aligned with ICH E6(R2).
• Andean Community Decision 418 (Manual of Andean Standards for Sanitary Registration), Decision 516 (Andean Cosmetics Harmonisation), Decision 705 (Andean Pharmacovigilance) + Decision 824 (Andean Medicines Harmonisation) — Andean Community Resolutions directly applicable in Colombia + Ecuador + Peru + Bolivia.

INVIMA's distinctive technical-scientific advisory model operates through the Salas Especializadas (Specialised Chambers) — panels of external scientific experts + INVIMA staff that provide binding technical opinions on registration applications + classification decisions + product safety + complex regulatory questions. The Sala Especializada model is one of INVIMA's most distinctive regulatory features + provides a transparent + expert-driven scientific assessment framework that combines internal regulatory capacity with external scientific expertise from Colombian universities + research institutes + medical specialty societies.

• Sala Especializada de Medicamentos y Productos Biológicos (SEMPB) — medicines + biologicals + biosimilars + vaccines; meets ~24x per year + reviews complex registration applications + safety signals + classification.
• Sala Especializada de Reactivos de Diagnóstico In Vitro (SERDIV) — IVDs + diagnostic reagents; meets monthly + reviews IVD classification + registration applications.
• Sala Especializada de Dispositivos Médicos y Productos Varios (SEDMPV) — medical devices + other health products; meets monthly + reviews medical-device classification + registration.
• Sala Especializada de Alimentos y Bebidas (SEAB) — food + beverages + dietary supplements; meets monthly + reviews food + supplement registration + safety questions.
• Sala Especializada de Productos de Higiene Doméstica y Cosméticos (SEPHDC) — cosmetics + household hygiene + cleaning products; meets monthly + reviews cosmetic + household-product registration.
• Sala Especializada de Farmacovigilancia — pharmacovigilance signal evaluation + risk-benefit assessment + safety-action recommendations.
• Sala Especializada de Productos Naturales Fitoterapéuticos y Homeopáticos — herbal + phytotherapeutic + homeopathic products.
• Sala Especializada de Plantas Medicinales y Sustancias Estupefacientes — controlled substances + medicinal cannabis (post-Law 1787 of 2016).
• Actas (Minutes) — Sala Especializada decisions are recorded in formal Actas published on INVIMA's website + are binding technical input to INVIMA registration decisions; Actas are a primary source of Colombian regulatory precedent.
• External Expert Membership — Sala Especializada experts are appointed from Colombian universities, research institutes, medical specialty societies + INVIMA technical staff; expert membership is renewable + subject to conflict-of-interest disclosure.
• Transparency Model — the Sala Especializada model is widely cited as a transparency + scientific-rigour benchmark for Latin American regulators + has been studied by other regional NRAs.

INVIMA medical-device + IVD regulation operates under Decree 4725 of 2005 + Resolution 4002 of 2007 with a Class I-III risk-based framework substantively aligned with GHTF/IMDRF + EU MDR. Foreign manufacturers must appoint a Colombian Authorised Representative (Importador / Titular). Sala Especializada SEDMPV (devices) + SERDIV (IVDs) review complex applications.

• Risk-based Classification (Class I / IIa / IIb / III) — substantively aligned with GHTF/IMDRF + EU MDR with Colombian-specific overlay; IVDs classified separately per Resolution 4002 of 2007.
• Registro Sanitario — issued by INVIMA Dirección de Dispositivos Médicos based on technical-file review + Importador / Titular designation + Spanish-language labelling + Sala Especializada SEDMPV / SERDIV review for complex products.
• Colombian Authorised Representative (Importador / Titular) — Colombia-resident legal entity required for foreign manufacturers; bears post-market Tecnovigilancia responsibility + INVIMA regulatory interface.
• ISO 13485:2016 — recognised by INVIMA as QMS evidence framework; Colombian-specific overlay required including Colombian quality records + Importador QMS interface.
• Reliance pathways — INVIMA accepts CE Mark + FDA 510(k) + Health Canada + TGA + Swissmedic + MFDS + Japan-approval evidence as supporting evidence under reliance framework; reliance reduces dossier + accelerates review.
• MDSAP — Colombia is not currently an MDSAP Participating Regulator + does not require MDSAP audit reports; however INVIMA accepts MDSAP reports as supporting evidence.
• Andean Community + Pacific Alliance Harmonisation — INVIMA participates in Andean Community + Pacific Alliance medical-device harmonisation work-streams; Andean Community Decision 516 covers cosmetics + work-streams cover device harmonisation.
• Post-market Tecnovigilancia — INVIMA operates medical-device adverse-event reporting through the Sistema Nacional de Tecnovigilancia; reporting timelines substantively aligned with IMDRF Adverse Event Reporting Codes.
• Cosmetic Notification — cosmetics under Decree 3554 of 2004 + Resolution 3823 of 2013 + Andean Community Decision 516 require Notificación Sanitaria Obligatoria (NSO) + Spanish-language labelling; INCI-aligned ingredient listing + safety substantiation + cosmetovigilance reporting.
• Colombian UDI — INVIMA is progressively implementing UDI requirements substantively aligned with FDA UDI + EU EUDAMED UDI; Colombian-specific overlay applies.
• Importation Permit — INVIMA Importation Permit required in addition to product registration for foreign-manufactured devices entering Colombia.

INVIMA operates the Programa Nacional de Farmacovigilancia under Resolution 3692 of 2018. The Colombian pharmacovigilance system integrates federal + departmental + hospital + community-pharmacy + manufacturer reporting through the EVRA (Eventos Adversos a Medicamentos) online platform + has substantial mature ADR reporting volume.

• Programa Nacional de Farmacovigilancia (PNFV) — coordinated federal-departmental pharmacovigilance programme with effector centres in major hospitals + Departmental Health Secretariats + Marketing Authorisation Holders.
• WHO PIDM Long-standing Member — Colombia is a long-standing WHO Programme for International Drug Monitoring member + contributes substantial ADR data to VigiBase via Uppsala Monitoring Centre (UMC).
• EVRA Online Platform — INVIMA operates online ADR reporting via the EVRA (Eventos Adversos a Medicamentos) platform; available for healthcare professionals + consumers + Marketing Authorisation Holders.
• E2B(R3) ICSR — INVIMA accepts E2B(R3) format ICSR submissions substantively aligned with ICH E2B(R3); 15-day SUSAR reporting timeline for clinical trials + post-market.
• PSUR / PBRER — periodic safety update reports substantively aligned with ICH E2C(R2); INVIMA-specific submission timeline.
• Risk Management Plans (RMP) — INVIMA requires ICH E2E-aligned Pharmacovigilance Plan + Risk Management Plan for new drugs + biosimilars + vaccines + high-risk products.
• Sala Especializada de Farmacovigilancia — Specialised Chamber for pharmacovigilance signal evaluation + risk-benefit assessment + safety-action recommendations.
• Active surveillance — INVIMA operates targeted active-surveillance programmes including for HIV antiretrovirals + tuberculosis + COVID-19 vaccines + biologicals + sentinel-site hospital surveillance.
• Tecnovigilancia + Cosmetovigilancia + Reactivovigilancia — INVIMA operates parallel materiovigilance (Tecnovigilancia) for medical devices, cosmetovigilance for cosmetics + reactivovigilancia for IVDs.

• WHO/PAHO Regional Reference Authority — INVIMA is a WHO/PAHO Regional Reference Authority for the Americas (originally designated 2011, re-confirmed 2021); designation reflects INVIMA's mature regulatory system + benefits PAHO Member States through reliance pathways.
• WHO Listed Authority — INVIMA is a WHO Listed Authority recognised for medicines + vaccines + biologicals + WHO PQ reliance.
• WHO PQ CRP Reference Authority — INVIMA is one of the active WHO Prequalification Collaborative Registration Procedure (CRP) Reference Authorities in the Americas + provides reliance assessments for WHO PQ purposes.
• PIC/S Applicant — INVIMA is a PIC/S Applicant + INVIMA GMP Resolution 3157 of 2018 + inspectorate practices are substantively aligned with PIC/S GMP Guide + Annexes; full PIC/S Membership is pursued.
• ICH Observer — INVIMA is an ICH Observer; ICH guidelines extensively implemented in Colombian regulatory practice including ICH Q7 + Q8 + Q9 + Q10 + Q11 + E2A-E + M4.
• ICMRA Participant — INVIMA participates in International Coalition of Medicines Regulatory Authorities (ICMRA) Working Groups + Strategic Initiatives.
• PANDRH — INVIMA is an active PANDRH (Pan American Network for Drug Regulatory Harmonisation) participant alongside FDA + Health Canada + ANVISA + COFEPRIS + ANMAT.
• Andean Community Co-Leader — INVIMA is a co-leader of the Andean Community (Comunidad Andina) Pharmaceutical Harmonisation framework alongside ARCSA Ecuador + DIGEMID Peru + AGEMED Bolivia; CAN Decisions 418 + 516 + 705 + 824 govern Andean pharmaceutical + cosmetic + pharmacovigilance harmonisation.
• Pacific Alliance Health Cooperation — INVIMA participates in Pacific Alliance (Chile + Colombia + Mexico + Peru) Health Regulatory Cooperation Working Group + bilateral cooperation with ISP Chile + COFEPRIS Mexico + DIGEMID Peru.
• IMDRF Affiliate — INVIMA is an IMDRF Affiliate Member + draws on IMDRF guidance for medical-device regulation.
• Bilateral MoUs — INVIMA holds MoUs with FDA + EMA + MHRA + Health Canada + TGA + PMDA + ANVISA + COFEPRIS + Chilean ISP + Argentine ANMAT + Peruvian DIGEMID + Ecuadorian ARCSA + Bolivian AGEMED + Uruguayan MSP + Paraguayan DNVS + Spain AEMPS + Cuban CECMED + Mexican CENADIM.
• ICDRA — active International Conference of Drug Regulatory Authorities participant + has hosted ICDRA Regional Conferences in Bogotá + Cartagena.
• OECD GLP MAD Participant — Colombia is an OECD Mutual Acceptance of Data (MAD) Adherent + INVIMA participates in OECD GLP work-streams.
• Industry Cooperation — INVIMA engages with Asociación de Industrias Farmacéuticas Colombianas (ASINFAR), Cámara de la Industria Farmacéutica de la ANDI (Asociación Nacional de Empresarios de Colombia) + AFIDRO (multinational industry association).

• Colombian Importador / Titular not properly designated — application rejected at INVIMA intake or post-approval compliance failure.
• Spanish-language labelling deficiencies — Spanish (Colombian variant) labelling + Spanish PIL (inserto) required; many applicants provide other Latin American Spanish variants without Colombian-specific terminology + tropical-climate storage-condition appropriateness.
• GMP Resolution gaps — applicants assuming EU GMP / PIC/S GMP compliance is automatically sufficient without addressing Colombia-specific INVIMA Resolution 3157 of 2018 clarifications + INVIMA-specific quality records.
• Colombian climate-zone stability data missing — Colombian Climate Zone IVa/IVb (tropical hot + humid Caribbean + Pacific coasts + Amazon) with Climate Zone II/III (temperate Andean) variations; many applicants provide insufficient zonal-specific stability data.
• Sala Especializada review timeline not planned — complex registration applications + safety questions require Sala Especializada SEMPB / SEDMPV / SERDIV / SEAB / SEPHDC review; Sala scheduling adds 2-4 months but is essential for novel + complex products.
• Andean Community harmonisation not leveraged — CAN Decision 418 + 824 provide harmonised dossier elements across Colombia + Ecuador + Peru + Bolivia; INVIMA + ARCSA + DIGEMID + AGEMED-led Andean Joint Registration substantially underutilised.
• Pacific Alliance reliance not leveraged — Pacific Alliance Health Regulatory Cooperation underutilised by applicants targeting multiple Pacific Alliance markets through ISP + INVIMA + COFEPRIS + DIGEMID coordination.
• PANDRH reliance not leveraged — PANDRH reliance pathway underutilised by applicants targeting multiple American markets through FDA + Health Canada + ANVISA + COFEPRIS + INVIMA coordination.
• WHO PQ CRP reliance under-utilised — WHO-PQ-approved products eligible for accelerated INVIMA CRP review; INVIMA is a WHO PQ CRP Reference Authority providing reliance to other regulators.
• ICA jurisdictional split — veterinary medicines + agricultural inputs + animal-origin foods sit with ICA (Instituto Colombiano Agropecuario), not INVIMA; avoid filing veterinary or animal-origin food applications to INVIMA.
• CNPMDM pricing scope — pharmaceutical pricing for SGSSS reimbursement sits with Comisión Nacional de Precios de Medicamentos y Dispositivos Médicos (CNPMDM), not INVIMA; registration + pricing are separate regulatory tracks.
• Variations strategy not planned — Type IA / IB / II variations procedure substantively similar to WHO but with Colombia-specific timelines + fee structure + Spanish-language requirements.
• Renewal timing missed — 5-year Registro Sanitario renewal must be filed within prescribed window before expiry; missed deadline triggers de-registration + market withdrawal.
• Clinical trial Resolution 4396 of 2019 + REC steps — Colombian clinical trials require INVIMA CTA + INVIMA-recognised Research Ethics Committee approval; sponsors sometimes overlook REC recognition + departmental REC variations.
• Pharmacovigilance + EVRA reporting gaps — INVIMA Resolution 3692 of 2018 + PNFV requirements substantively similar to ICH E2 + EU GVP but with Colombia-specific EVRA submission requirements + Spanish-language ICSR.

V5 Ultimate provides the operational infrastructure Colombian + foreign-supplier sites need for Law 100 of 1993 + Decree 1290 of 1994 + Decree 677 of 1995 + INVIMA Resolution 3157 of 2018 GMP + INVIMA Medical Devices framework + Andean Community + Pacific Alliance + PANDRH + WHO PQ CRP + Programa Nacional de Farmacovigilancia + Sala Especializada readiness.

• INVIMA GMP Resolution 3157 of 2018 control framework — PIC/S + EU GMP + ICH Q7-aligned controls (clean rooms, aseptic process, environmental monitoring, computerised systems) with ALCOA+ data-integrity + Colombia-specific clarifications + Colombian climate-zone IVa/IVb/II/III stability monitoring.
• INVIMA drug-registration packaging — Colombian CTD-aligned dossier structure with Colombia Module 1 specifics + Module 3 stability + Colombian inserto (PIL) + Spanish (Colombian variant) labelling + Importador / Titular declarations + Decree 677 of 1995 framework.
• Sala Especializada workflow — Sala Especializada SEMPB / SEDMPV / SERDIV / SEAB / SEPHDC / Farmacovigilancia packaging for complex registration applications + safety signals + classification questions; Acta tracking + scientific-evidence packaging.
• Andean Community workflow — CAN Decision 418 + 824 harmonised dossier packaging for joint registration across Colombia + Ecuador + Peru + Bolivia; Comité Andino de Autoridades en Medicamentos coordination.
• Pacific Alliance workflow — Pacific Alliance Health Regulatory Cooperation packaging for joint registration across Chile + Colombia + Mexico + Peru; ISP + INVIMA + COFEPRIS + DIGEMID coordination.
• PANDRH workflow — PANDRH reliance pathway packaging for products assessed by FDA + Health Canada + ANVISA + COFEPRIS + ANMAT + INVIMA Reference Authorities.
• WHO PQ CRP workflow — INVIMA as WHO PQ CRP Reference Authority + applicant-side WHO PQ CRP packaging with reduced dossier + accelerated INVIMA review.
• Colombian Importador / Titular workflow — foreign-manufacturer Importador designation + role-management + Colombia-specific post-market surveillance + INVIMA interface.
• Colombian clinical-trial workflow — INVIMA Resolution 4396 of 2019 GCP + INVIMA-recognised REC + INVIMA-registered investigator + Colombian SUSAR reporting via EVRA.
• INVIMA Pharmacovigilance + EVRA integration — E2B(R3) ICSR generation + 15-day SUSAR timeline + PSUR / PBRER packaging + Spanish-language ICSR + PNFV effector-centre coordination + EVRA submission + VigiBase upload + Risk Management Plan packaging.
• Tecnovigilancia + Cosmetovigilancia + Reactivovigilancia workflow — parallel materiovigilance + cosmetovigilance + IVD-vigilance packaging.
• Medical-device + cosmetic + IVD workflow — Decree 4725 of 2005 + Resolution 4002 of 2007 + Decree 3554 of 2004 + Resolution 3823 of 2013 + CAN Decision 516 dossier packaging + Class I-III classification + ISO 13485 + Importador / Titular + post-market Tecnovigilancia.
• INVIMA Variations workflow — Type IA / IB / II classification + INVIMA procedure + Colombian packaging.
• Renewal workflow — 5-year Registro Sanitario renewal window tracking + INVIMA procedure packaging.
• Andean + Pacific Alliance + PANDRH regional bridging — for companies operating across Latin America, V5 surfaces INVIMA + ANVISA + COFEPRIS + ANMAT + ARCSA + DIGEMID + AGEMED + ISP Chile + Uruguayan MSP + Paraguayan DNVS + Cuban CECMED + Venezuelan INHRR harmonised dossier-element reuse alongside national-specific extensions.