Pérez: We are changing the paradigm. For many, many years, it has been definitely administrative processes. Guided by administrative processes, basically. Very bureaucratic administrative processes. Nevertheless, it is important that there is a lot of development and innovation by industry. And furthermore, there are many, many products in the early stages of development that are showing a lot of value in the early process of development that really work in patients. One of the big problems of risk is that there are a lot of advancements in industry regarding innovation that when it comes to the regulatory agency, the regulatory reviewers are not keeping abreast of all this innovation and all these processes and all of these advancements. So this kind of causes an issue there. The regulatory reviewer has to embrace that knowledge. The only way this happens if there is an agreement, a marriage, between the regulatory authority and industry, when they all try to merge and speak the same language and be at the same level of understanding.

It is very important to mention that in Cuba, it is a very special country because Cuba is extremely high-tech, has very advanced innovation, research and development, and it is so advanced from a strategic and scientific standpoint, but it is a third-world nation. So we have implemented an internal strategy. From a regulatory standpoint, the agency has periodic reviews of the development projects in Cuba. For example, in preclinical stages of development, the industry is in touch with the regulatory agency. The regulatory agency monitors all these steps of the development of each product, a periodic review of what they are doing and how they are doing it, so that the agency has more of a relationship with the preclinical development scientists so that they both gain the knowledge, and they can be working together on the development of a product.

It's more of a closer interaction because we are a third world nation and don't have access to all the innovation. It has brought us to the point where we have a conditional approval of a product to be introduced in a controlled fashion into the Cuban health care system. That has allowed them to benefit more patients. They can take more care of orphan diseases in their own population. So they can take more care of patients in this respect because they know the pathway is more assured, because it is a very tight-knit collaboration between industry and regulators in the development. This has also helped in the review timeframes, and of course the approval process. In other Latin American countries, there are some other agencies that take over two years to approve a drug. That is very much needed. In Cuba, it is the opposite. They start working together and collaborating in the very beginning. That's why we are changing the paradigm in regulatory sciences, so that the regulated industry exchanges more with the agency reviewers. And agency reviewers can take better, faster and more precise and concise decisions when they approve a product. Based on true and real risk/benefit evaluation when it comes to approving a drug.

Cuba's CECMED Director Reflects On Agency Transformations, Ongoing Challenges

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