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Understanding the OTC and Pharma Regulatory Process and Requirements in Colombia

Get The Important Insights!

Colombia is one of Latin America’s most promising consumer health and pharma markets. The first step to successfully entering this market is understanding the government regulations and requirements. Therefore, the article aims to give essential insights into the regulatory process. 

Market Drivers 

Colombia, being the third most populated country in Latin America has a lot to offer. Even if its OTC and prescription market is not as large as the Brazilian or Mexican, it has strong growth potential in future years.  

  • Colombia has a stable and attractive healthcare system and is the third country in the region with the highest share of public spending on healthcare. 
  • 95% of the Colombian population is insured under the general social security health system, SGSSS. 
  • The healthcare market is forecasted to grow at a CAGR of 10,09% from 2025 until 2035, reaching approximately USD 10,38 Billion by 2035. 

The pharmacovigilance institution of Colombia 

In Colombia, the INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is the authority that regulates the registration and safety of consumer health and pharma drugs. In recent years the authority has been internationally recognized for its high regulatory standards and approval times, making Colombia more attractive to OTC and Rx companies. 

Inside knowledge of the Regulatory Process 

New Rx, consumer health and phyto drugs need to be in line with the regulatory requirements of the INVIMA to be introduced into the market. It enables the marketization and further commercialization of the medicines. 

This procedure can take more or less time, due to the fact that the regulatory conditions are constantly changing but this largely depends on how one decides to approach the local process. For medicines already registered in countries like Japan, USA, Australia, Norway, Germany, Canada, France, Switzerland, Sweden, England, Denmark, and the Netherlands, the evaluation process could be even shorter. 

The Drug Regulatory Process 

The difficulty of the registration process in Colombia is intermediate. However, with our valuable up-to-date insights and expertise, we will clarify the regulatory processes and support you for a speedy and successful market entry.  

  • The applicant must prepare and submit a dossier to the INVIMA. If there are new molecules, they will make a new molecular committee review.  
  • The review and evaluation process can take up to 4 to 6 months 
  • During that time, the company must register its brand name in the country.  
  • The applicant must comply with the standard registration procedure. 
  • The detailed dossier is submitted.  
  • The authority issues a certificate of pharmaceutical evaluation. If everything is in line with the required standards, approval is granted 

The whole process may take only 10 to 14 months and then the phyto and OTC drugs will be ready to be commercialized in Colombia’s consumer health and Rx market.  

Infographic: Colombia – OTC, Phyto and pharma Registration process and time 

Chameleon Pharma Consulting Group and our local Colombian CPC experts offer the most upto-date insights on regulatory changes and local networks in the global pharma industry. We will gladly support you in registering your pharma products and guaranteeing your company a speedy and successful market entry. 

Feature picture: Photo by Saul Mercado on Unsplash


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