Leading the Way in Third-Party Regulation

Q: How has the company advanced in its certification processes since 2015?

A: After completing the authorization process with COFEPRIS we focused on getting biotechnological, vitamin and herbal products certification. It was a complex process and the commission was mindful of every detail when testing our processes. As we are certified in biotechnological products the first new molecules have already been authorized via a pre-review process through TAPVS. The sector is increasingly moving toward biotechnological medicines and TAPVS is becoming a key partner in the process.

Q: How have COFEPRIS’ latest changes in regulation affected TAPVS’ operations?

A: We always adapt to COFEPRIS’ standards and we have seen many positive changes. The new regulations establish a post-commercialization approach that forces companies to really think about the inherent sanitary risks of any product. As a result, there is a significant improvement in pre-commercialization norms leading to pharma and technical vigilance. The government focuses on tracking the behavior of the product once it reaches the market, more in line with how the international sector works.

Q: How could COFEPRIS incentivize further investment in projects similar to TAPVS’?

A: The vision of COFEPRIS’ new head, Julio Sánchez, follows Mikel Arriola’s previous strategy to protect people from any sanitary risks, while taking into consideration the economic implications for all players regulated by the commission. Making vigilance processes much more assertive and establishing clear regulations incentivizes newcomers to consider Mexico as an investment destination. Furthermore, it pushes these companies to not only seek strategic partners but also bring their full operations to the country. One of TAPVS’ main drivers has always been customer service and focusing on clarity and time efficiency so our clients can get their marketing authorizations as soon as possible. In the end, COFEPRIS’ trust makes our job much easier.

Q: What trends has TAPVS detected in the pharma sector?

A: We see a definite trend toward generic solutions. Many patents became public in 2016 and we expect more to expire in the following year. However, we also see many new molecules coming into the country. It is not widely known the national sector is investing considerably in new research. It is true that Big Pharma is registering trends related to a drop in clinical studies, but Mexico has all the necessary advantages to become an international standard in this area. We have the right infrastructure, we have qualified doctors and we have a considerable genetic diversity, particularly in the north of the country.

Q: What has been TAPVS’ development in the domestic market over the last few years?

A: We have maintained constant double-digit growth rates and although we previously reported rates of 40- 50 percent we are now consolidating at 10-13 percent margins. We are not worried about this and we have always considered competition as our best ally. We are now reinventing our business to adopt more advanced IT tools, methodizing ruling processes, standardizing revisions and making our operations far more efficient. This has also been a major advantage for our clients, since they know exactly what we need to follow up on their registrations. Through our Workflow platform, COFEPRIS can supervise all our activities so there is no way we can make any mistakes. We have already implemented this solution. This is an excellent alternative in terms of sustainability as well, since we can store all information digitally and delete it once we do not need it anymore.

We have even worked on specific ruling guidelines we expect will help revolutionize the regulation process in the country. Furthermore, considering the benefits it has brought to the pharma market, certification outsourcing can be an excellent solution for other industries as long as the government establishes the proper regulation. The oil and gas sector has already taken advantage of this solution and the country is now looking to integrate this system in the industrial patent registration process.