Certainly, with respect to its size alone, Colombia does not hold the same importance as Brazil or Mexico. By most accounts, it would rank fifth in terms of how large its pharmaceutical market is, behind Mexico, Brazil, Argentina, and Venezuela. Nevertheless, with a market for pharmaceuticals that was worth US$1.8 billion in 2006, and a growth rate of 5%, the Colombian market is nothing to sneeze at.
Indeed, Columbia has become, perhaps somewhat unexpectedly, a destination for clinical trials. The regulation of clinical trials in Colombia is entrusted to the Instituto Nacional de Vigilancia de Medicamentos y Alimentoa (INVIMA). While the 17- to 21- week time frame for approval presents a longer timeline than what is found in Mexico, it is still considerably shorter than the length of time that the process requires in Brazil. The key initial documents consist of the protocol, ICF, IB POA, and an insurance policy for the Colombian sites.
Although it is required that the protocol for each site be approved by IRBs, once the IRB approves the protocol for the first site, it can be submitted for INVIMA to approve. INVIMA must then be notified of additional sites. Once a company has approval from INVIMA, it can request an import license for the study drug and other supplies.
In contrast to the challenges that protocols with a placebo arm present in Brazil, there are no such special concerns with placebo-controlled studies in Colombia as long as it is approved by ECs.
On the other hand, the clinical trials regulation in Colombia presents its own set of challenges. In particular, a new resolution was introduced in 2008 that requires GCP and a certification of institution by INVIMA in order for a company to be able to conduct clinical research. Consequently, all protocols that are submitted to INVIMA for approval will need to also include a copy of the submission of a certification plan.
Putting aside the potential for conducting clinical trials in Colombia, the pharmaceutical market, in general, is also ripe with possibilities. Since the 1930s, when the pharmaceutical industry in Colombia essentially consisted of just three local manufacturers and ten foreign subsidiaries, the Colombian pharmaceutical market has developed and blossomed. Today, the domestic industry is considered relatively well developed although rather fragmented. This market fragmentation itself can be seen as a source of opportunity for companies entering Colombia.
Also worth bearing in mind, as with most other countries in Latin America, the time and cost associated with registering a pharmaceutical product in Colombia, both with respect to new, as well as similar or generic pharmaceuticals, is significantly lower than in the U.S. or Europe. New drugs take six months to register, while similar and generic drugs can be registered in merely three months.
However, although the pharmaceutical market in Colombia holds a great deal of appeal, there are also challenges to entering and operating in this market that a pharmaceutical company ought to be aware of when considering doing business there.
One challenge is the high incidence of under-the-counter sales in pharmaceuticals in Colombia. Additionally, counterfeit products make up about 2–3% of the pharmaceutical market value. This particular issue, however, may become less of a concern in the future; the prevalence of counterfeit pharmaceuticals is decreasing in Colombia thanks to the adoption of good manufacturing practices.