Julio Sánchez
Federal Commissioner
View from the Top

All Inclusive Ecosystem Would Provide Benefits

Wed, 09/05/2018 - 09:42

Q: How have COFEPRIS’ policies shaped the pharmaceutical sector?
A: Our road map, developed in 2016, has marked the path to improvement throughout these years. In January 2018, COFEPRIS introduced a new regulation on pharmacovigilance and techno-vigilance and has made great strides in facilitating approval processes and reducing times. One of our pillars is effective communication with the industry. The ultimate goal is the generation of public policies that benefit patients and permit industry development.

Q: How is COFEPRIS aligning its policies to their international counterparts?
A: The challenge that all regulatory authorities face is to generate predictable and stable environments for doing business and all international bodies share similar hurdles in this regard. The first is to guarantee access. The second is to regulate the evolution of technology used for both medicines and medical devices since technology is making diagnostics techniques more powerful and faster than in previous years. The third challenge is to maintain an active and close communication to generate prevention schemes for common diseases like obesity. For the healthcare sector, it will be much less expensive to prevent obesity than to treat it.

Q: What should COFEPRIS’ goals be regarding international policy?
A: Regulatory authorities are more efficient if they collaborate closely with their peers around the world, since the concerns are almost the same on all continents. The alignment of policies allows the simplification of processes and saves companies from having to perform the same clinical studies several times or to perform several plant reviews. In these cases, a revision from a Stringent Regulatory Authority (SRA) should be sufficient. Among our goals, is for Mexico to be qualified as an SRA in the Americas once the WHO makes this term official. Since 2017, COFEPRIS has been among WHO’s reference bodies. Within WHO, we coordinate FDA, Health Canada and other health regulators, including Cuba, Colombia, Chile, Argentina and Brazil, and we will do so until 2019. COFEPRIS is also Vice President of the International Coalition for Medicines Regulatory Authorities (ICMRA). From January 2018, COFEPRIS entered the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which will allow us to greatly reduce the number of visits to foreign plants to grant them a certification of good manufacturing practices, saving approximately MX$1 million per visit.

Q: How is the role of COFEPRIS evolving to support epidemiological changes in the country?
A: From 2010, COFEPRIS has approved 550 generic medicines and 310 innovative medicines, of which 64 were orphan drugs. Our work with generics is one of this administration’s greatest achievements, as these medicines cover 70 percent of Mexico’s main mortality causes and bring about a 60 percent overall reduction in costs. To continue incorporating more medicines and address diseases that might have been overlooked, we recently signed an agreement with the Mexican Federation of Rare Diseases for the creation of a permanent committee that incorporates patients, regulators and the federation to analyze the medications that should be brought to Mexico.

Q: Considering how quickly technology evolves, how can regulatory bodies keep pace?
A: We have created a committee that evaluates new drugs and medical devices and provides support for their developers throughout the commercialization process. Investment in R&D carried out by other countries comes long after its development, but the creation of this committee allows us to be ready when the new technology arrives for its faster introduction into the country. Our Excellence Center is a space for discussion among academia, regulators and theindustrywhosegoalistocloseanygapsinknowledge. Its ultimate goal, announced in March 2018, is the creation of a National Plan for Regulatory Sciences.