Isidro Rodríguez
Director General
View from the Top

Cutting Through Paperwork to Reach the Market

Wed, 09/07/2016 - 15:21

Q: In recent years the role of authorized third parties has been growing strongly in the Mexican healthcare sector. What specific needs do authorized third parties address?

A: In 2010, COFEPRIS announced the creation of third party authorized units for the pre-approval of medicines and medical devices. COFEPRIS decided to create these units taking into account the large backlog of registries they had at the time alongside new registrations. By law, COFEPRIS has to answer every submission. In some cases the products are easily authorized, but much more information is required. As COFEPRIS previously had to closely follow the entire approval process and thoroughly review all the information, granting approvals or rejections was a highly time-consuming process. COFEPRIS gave third party authorized units the responsibility to ensure all information submitted is accurate and correct, saving COFEPRIS´ time. COFEPRIS always has the final decision on every registration, since it has a large responsibility in regulating medical devices and medicines and we are held accountable if a product validated by us has negative health consequences.

Q: What strategies have you used to position the company in the Mexican market?

A: We began by searching for companies needing to submit registrations in Mexico. The first step was to gain their trust, convince them that we have all the expertise they require and that we will not waste their time with unnecessary paperwork. As a third party, the most important thing we handle is our clients’ trust.

Third party authorized units seem like a strange concept to foreign and local companies because they are usually not aware that these are fully authorized by COFEPRIS. We often have to explain to our clients that we are authorized by the council and the concept of third party authorized units is not new since it has already been utilized for other industries. The council applied this concept to medicines and medical devices, which was perceived as risky as it involved large responsibilities on public health. However the system has worked correctly and we are able to provide the necessary drugs and medical devices much faster to the Mexican population.

Q: What are the main services you provide and what is the added value of the services provided by Entimem?

A: We started working exclusively with medical devices. Afterward, we expanded to incorporate drugs, both in registration and modification of registries. At this point, there are 20 third party authorized units and all of them are able to do the same activities. To differentiate ourselves we offer value-added services including our Solution Ecosystem which encompasses all services we provide to help companies to register their products in Mexico with a network of companies that provide complementary services in the health industry such as translations, legal consulting, imports and distribution.

Q: What new services are you planning in the near future?

A: We plan to expand our services to other areas of the economy, for example to provide certification for drivers, electric devices, biotechnology drugs, pesticides food manufacturers and restaurants. COFEPRIS is also planning to allow third party authorized units to regulate vaccines, which is a very interesting and challenging area as it requires working with the WHO.

Q: What strategies is Entimem implementing to attract foreign and local clients?

A: At this point several companies around the world are under the impression that regulations in Mexico are overly complicated, so our goal is to bring more foreign companies. Next week, for example, we will go to Colombia to promote our services, as many companies in that country want to import to Mexico but they are unaware of the proper procedures. More companies, both from Mexico and the rest of the world, are seeing Mexico as a strategic country to enter the rest of Latin America, and for that reason there are increasingly more registries for medical devices and medicines.