Colombia combines an ideal environment for botanic-based medicines and related products, as well as a well-structured, complete regulatory framework.

Pharmaceuticals, Medical Devices, Biotech & similar industries

GMP regulations in Colombia are designed to safeguard public health, ensuring that medications and healthcare products are safe, effective, and of high quality. These regulations are overseen by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), the national health authority responsible for regulating pharmaceuticals and other domains.

INVIMA, headquartered in Bogota, was founded in 1953 and covers the areas of Pharmaceuticals, Food, and Cosmetics. The drug approval process parallels that of the FDA and other world agencies. A dossier (like the FDA IND) precedes a series of phased clinical trials, which can vary according to the type of drug being developed.    For a drug candidate, prior drug approvals from the EU or USA can greatly expedite the process, due to their recognized stringent regulatory procedures and high standards.

In addition to drug approvals, pharmaceutical manufacturing plants must undergo registration with INVIMA. For INVIMA drug manufacturing site registration under Good Manufacturing Practices (GMP), the following documents are typically required:

• Site Master File (SMF)
• Quality Manual
• Standard Operating Procedures (SOPs)
• Validation Master Plan (VMP)
• Validation Protocols and Reports
• Electronic Batch Records
• Equipment Qualification Documentation
• Cleaning Validation Documentation
• Change Control Procedures
• Training Records
• Quality Control Records
• Deviation Reports

INVIMA also classifies both pharmaceuticals and medical devices according to their use:

• Class I Medical Device: Bandages, non-invasive thermometers.
• Class Ila Medical Device: Hearing aids, syringes.
• Class IIb Medical Device: Surgical lasers, infusion pumps.
• Class III Medical Device: Implantable pacemakers, heart valves.
• Pharmaceutical Class A: Over-the-counter painkillers.
• Pharmaceutical Class B: Prescription antibiotics.
• Pharmaceutical Class C: High-risk medications like immunosuppressants.

Dietary Supplements, Nutraceuticals

Colombia is one of the most biodiverse countries in the world. This means a great array of botanical supplement ingredients can be successfully grown within a reasonable transport distance to processing facilities.

INVIMA also regulates these products in Colombia. INVIMA requires a detailed registration process for nutraceutical manufacturers (requiring a GMP (Good Manufacturing Practices) certificate), as well as labelling guidelines, and restrictions on health claims.

Manufacturers of nutraceutical products are generally expected to follow Good Manufacturing Practices to ensure the quality, safety, and consistency of their products.

Vaping and e-cigarettes

It is illegal to purchase and use these products for anyone under 18 years of age.

Cannabis

Colombia is known for its favorable climate and ideal growing conditions for cannabis, which has attracted significant investment in the industry worldwide, as well as interest and renown in the recreational community.

Cannabis is only officially legal for medicinal purposes in Colombia at this time. Recreational use of cannabis in Colombia is currently decriminalized up to the possession of 20 grams.

Hemp products are legal if the THC level is below 1%.

Colombia has much going for it to be a significant commercial provider in the regulatory product categories that tap local strengths. Its regulatory organization is well equipped to ensure the quality and safety of the products it covers.

InstantGMP offers systems and expertise to address INVIMA compliance by reducing paperwork and automating general documentation tasks. Our systems are now available in Spanish.  www.instantgmp.com

 

References

INVIMA   www.invima.gov.co

Team Conical Pharmaceuticals, Ms. Ritika Patel  www.conicalpharmaceuticals.com

Artixia www.artixia.com

Colombia One www.colombiaone.com  Josep Freixes

MyCannabis   www.mycannabis.com  Melanie Paige