Digitization of Regulatory Files to Accelerate Processes

Q: What was the reason to create Total Integridad y Confianza Internacional (TIC INTL)?

A: We observed the need for solutions for a regulated industry like the sanitary industry. Mexico’s health regulation is complex because it is decentralized and there are many regulatory authorities. For this reason, we want to be a viable solution for new companies seeking to introduce their products to the market by assisting them in navigating complex health regulations and ensuring compliance. We are focused on compliance and regulations, while also integrating quality management. We have specialized in accompanying new companies, a sector that grew in the pandemic, specifically in the health sector.

Other Consultancies often have many limitations, such as having staff with experience in only some fields. This situation forces companies to look for solutions in different places. TIC INTL offers all solutions for any sanitary business by integrating different specialists under a quality system to guarantee adequate results.

Q: How should regulation evolve to become a booster instead of an obstacle for innovation in post-pandemic times?

A: Health regulation is complex because it is very difficult and confusing, so the sanitary industry needs regulation that is clear and transparent for everyone. The sector requires well-drafted regulations with systematic and transparent criteria. 

Regulation can be a barrier if it is unclear and causes confusion. Complex processes also hinder entrepreneurship. It is common for entrepreneurs with an idea and seed capital to have to wait approximately one and a half years for the regulatory process to finish. Regulations and timelines must be clear from the start to plan a launch. Unfortunately, new companies are often born without adhering to regulations and only later undergo the process.

Q: In this scenario, what is the role of the regulatory authorities? 

A: It is hard to write regulations that manage all risks properly. COFEPRIS also has a huge burden of jurisdiction. Unlike in other countries, in Mexico many different products and services fall under COFEPRIS’s jurisdiction and only minor processes are delegated to the federal health system and to verification units. For this reason, those being regulated must provide high-quality, clear documentation so the regulator can efficiently and easily review it. 

Regulators have to review a large amount of information. The reviewers do deserve respect. Collaboration between the regulated and the regulator is necessary so that things can flow more efficiently.

Q: How would you evaluate the advances of COFEPRIS’s Digipris initiative?

A: In 2003, when I was at COFEPRIS, we were working on the submission of the first electronic dossier. While there was excitement around this project, there were also many doubts and the main one pertained to information security because cybersecurity was mature enough at the time. After a great deal of work, this initiative was launched in 2004.

Digipris shows great progress and, while there is still a large gap regarding information security, we believe it will be successful. This first stage is digitizing the self-management procedures that represent a minor burden for authorities but the real opportunity will come from the integration of AI, an automated system that provides clear rules, certainty and transparency, while eliminating human error. The overall process also becomes more efficient as humans will only focus on what is truly important. This way processes can be managed correctly while the Mexican population continues to be protected against sanitary risks.

At ITC INTL, we have implemented machine learning, although we have not written the implementation code yet. But with it, we could manage thousands of documents from multiple dossiers.

Q: How ready is the industry for the complete digitalization of these processes?

A: Unfortunately, there is still a large gap in digitalization. While some businesses are ready for this transformation, others are just not prepared. Some industries are more prepared than others. The food industry, for example, is ready but the pesticides and plant nutrients sector continues to lag behind. Agribusiness is important because Mexican products are attractive for export but this industry is still lagging behind in digitization. COFEPRIS also needs to assess whether it is ready to serve all industries.

Total Integridad y Confianza Internacional (TIC INTL) is a platform that supports the main actors in the life sciences’ supply chain.