A primer on market authorizations for health care biotech products in Colombia

April 16, 2020

Small and intermediate life science companies looking to enter Latin American markets will consider several variables to gauge their local market success before engaging in the preparation and execution of a market introduction strategy.

With approximately 50 million people, Colombia is the third-largest market in Latin America and is a developing hub for several industries in the region. Colombia needs novel biotechnologies to address an array of key health issues. Furthermore, because of its well established regional academic and specialist connections, inland developments in the health care industry will resonate in neighboring counties. Thus, visiting and exchange health care professionals and KOLs are very likely to get to know new technologies and be willing to adopt them in their home countries.

In Latin America, Colombia stands out as a viable regional launching point for novel biotechnological human healthcare and MedTech products.

As in many other countries, in Colombia, new health care products require government authorization before market introduction. Colombia’s national agency for food and medicaments surveillance–INVIMA, for its initials in Spanish, is in charge of granting this type of market authorization. Depending on INVIMA’s product classification, largely aligned with that of the European Medicines Agency, market authorizations in Colombia are valid for 5 or 10 years.

Small and medium-sized life science industries planning on entering the Colombian market, may not be fully aware of the local ethos. We would like to provide three pieces of advice to help them prepare for a successful regulatory strategy around their technology.

1. Team-up with local consultants who understand your product and can communicate it effectively

Innovative biotechnology and MedTech products are developed from cutting-edge ideas, yet their purpose should be straightforward to grasp. The right consultant team for your company is not only able to understand what sets your products on the foreground and why they offer the best solution to local needs, but it also stands for you and communicates effectively with regulatory bodies. Furthermore, dealing with INVIMA, you are going to need a consultant team that is highly committed and proactive.

2. Be flexible about the time to market authorization

Dossier preparation and submission, in paper or electronic format and following local specifications, is only one part of the job. Although INVIMA has a fairly well-established dossier review protocol and counts with knowledgeable officers, the agency rarely meets its promised target dates. For instance, products in the category In vitro diagnostic reagent Class II have an intended review time to approval of 90 workings days, but, in practice, approval arrives in twice as much time. This is because INVIMA does not consider query management times upfront.

Dossier review of novel biotechnological and MedTech products will surely involve queries. Careful consultants will be able to foresee and minimize their occurrence by conducting pre-submission meetings with the agency and preparing dossiers thoroughly. INVIMA’s processing of queries and their communication to sponsors is not swift enough, so your consultants need to follow up tightly on the process and find the best communication channels with the agency.

3. Consider conducting local clinical studies before or after having requested a market authorization

The market success of an innovative biotechnological or MedTech product can depend on the confidence distributors, KOLs, and healthcare professionals have in it, and whether they are convinced about working with /advocating for it. Clinical studies provide tangible information on product performance in the target market and supply the best evidence to persuade the right stakeholders. In case you want to conduct clinical studies before having a market authorization, you will require INVIMA permission to run the study and to import the product needed.

Another advantage of taking this course of action is that the same group of stakeholders you intend to become the users of your product will be testing it. This means you will gain valuable insight into the local use conditions of your product. Consequently, you may consider optimizing or adapting your product to the market.


Final remarks

Plan your regulatory submission strategy aided by the local consultants of your choice whom you can trust, communicate openly with, and who can answer for your company and your products to regularity authorities.

Allow more time than initially estimated for approval to market. Use the insights from your local consultant to foresee costly bottlenecks, such as queries, and avoid them. Should queries show up, make sure your consultant counts with a response team that promptly addresses these queries and requests for additional information. Quick responses facilitate the review process.

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    Author: Ricardo Wilches, PhD
    Ricardo is Associate Consultant at SupportA. He counts with 11+ years of research experience in genetics and genomics within interdisciplinary and international teams. He has lead projects investigating the genetic underpinnings of monogenetic and complex traits in humans and animal models.