Q: What is the PPROVigi platform, its target market and the benefits for users?
A: G8 countries have integrated healthcare systems in which even paramedics can send pharmacovigilance reports. This is not the case in Mexico, so we wanted to develop a system that the regulator, constituents of the healthcare system and research institutes could all use. Patients and healthcare professionals can access it using cellphones and pharmaceutical companies and big hospitals can use the web version to capture information, verify quality control, check the MedDRA code, an international medical terminology dictionary, and submit reports to COFEPRIS online. The platform is available to all hospitals and research institutes free of charge or at subsidized cost. Pharmaceutical companies and other marketing authorization holders should subscribe to this platform to perform their pharmacovigilance operations. Principally, pharmaceutical laboratories are attracted to this platform because it adds many functional efficiencies to their pharmacovigilance operations, due to the network of hospitals also using the platform.
Q: The 2012 NOM-220-SSA1 is on your website. When will you start helping clients to comply with the 2015 version?
A: Once the new version of NOM-220-SSA1-2012 is published in the Federal Official Journal, we will update the website. We have a ready reckoner waiting to go to print that contains a synopsis of the law and all applicable instances to Latin American countries. As soon as it is made official, we will print the book and distribute it to all our clients. Many companies in Mexico have their Latin America head offices here and we want to give them a single snapshot of the region. Some of the biggest changes are in the frequency of reporting, the content of each report and the requirement of risk-management plans. Previously, the risk management plans had no categories. The changes to the NOM will introduce three classes. Class 1 is for generics or time-tested drugs with a low or well-established risk profile that makes for an easy renewal process. Class 2 is a little more complex, containing medicinal products with uncertain risk or with evidence of safety concerns while Class 3 is composed of newly approved medicinal products that can be new molecules or new combinations for which there is not yet ample evidence to demonstrate their safety in Mexico. With no exceptions, Class 3 products should undergo a pharmacovigilance study even though they represent only between 10 and 20 percent of drugs.
Q: What main issues do your customers face? How do you help to solve them?
A: Most companies face problems in drafting protocols and risk-management plans or adapting them to local regulations for pharmacovigilance studies, so they need help in drafting and adapting them through their global offices. We also run the outsourcing of pharmacovigilance units for those companies that prefer to have a lean organizational structure in Mexico and focus on their core activities. The execution of post-authorization safety studies is one area in which companies need help from an established player like us. We are creating a document-management system for COFEPRIS and the industry so they have a digital system to facilitate renewals of all the sanitary authorizations that contain references to pharmacovigilance requirements.
Q: What will be your main priorities for the rest of 2017?
A: We hope to bring all pharmaceutical industry players into the PPROVigi network. We have already brought IMSS on board and we are working with the Coordinating Commission of the National Institutes of Health. The School of Medicine at UNAM already has working arrangements with us. Later, we will turn to the remaining institutes such as ISSSTE, PEMEX and a couple of big hospitals from each state to have uniform representation of side-effects across Mexico. It usually takes two to eight months to bring any institute on board after complying with their processes. We want to reach a 50/50 business split between Mexico and Latin America because we want to be in touch with other national regulators.