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ALL INCLUSIVE ECOSYSTEM WOULD PROVIDE BENEFITS JULIO SÁNCHEZ Y TÉPOZ Federal Commissioner for Protection Against Sanitary Risk (COFEPRIS) 42
Q: How have COFEPRIS’ policies shaped the
our goals, is for Mexico to be qualified as an SRA in the
pharmaceutical sector?
Americas once the WHO makes this term official. Since
A: Our road map, developed in 2016, has marked
2017, COFEPRIS has been among WHO’s reference
the path to improvement throughout these years. In
bodies. Within WHO, we coordinate FDA, Health Canada
January 2018, COFEPRIS introduced a new regulation on
and other health regulators, including Cuba, Colombia,
pharmacovigilance and techno-vigilance and has made
Chile, Argentina and Brazil, and we will do so until 2019.
great strides in facilitating approval processes and reducing
COFEPRIS is also Vice President of the International
times. One of our pillars is effective communication
Coalition for Medicines Regulatory Authorities (ICMRA).
with the industry. The ultimate goal is the generation of
From January 2018, COFEPRIS entered the Pharmaceutical
public policies that benefit patients and permit industry
Inspection Co-operation Scheme (PIC/S), which will allow
development.
us to greatly reduce the number of visits to foreign plants to grant them a certification of good manufacturing practices,
Q: How is COFEPRIS aligning its policies to their
saving approximately MX$1 million per visit.
international counterparts? A: The challenge that all regulatory authorities face is to
Q: How is the role of COFEPRIS evolving to support
generate predictable and stable environments for doing
epidemiological changes in the country?
business and all international bodies share similar hurdles in
A: From 2010, COFEPRIS has approved 550 generic
this regard. The first is to guarantee access. The second is to
medicines and 310 innovative medicines, of which 64
regulate the evolution of technology used for both medicines
were orphan drugs. Our work with generics is one of this
and medical devices since technology is making diagnostics
administration’s greatest achievements, as these medicines
techniques more powerful and faster than in previous
cover 70 percent of Mexico’s main mortality causes and
years. The third challenge is to maintain an active and close
bring about a 60 percent overall reduction in costs. To
communication to generate prevention schemes for common
continue incorporating more medicines and address
diseases like obesity. For the healthcare sector, it will be
diseases that might have been overlooked, we recently
much less expensive to prevent obesity than to treat it.
signed an agreement with the Mexican Federation of Rare Diseases for the creation of a permanent committee that
Q: What should COFEPRIS’ goals be regarding
incorporates patients, regulators and the federation to
international policy?
analyze the medications that should be brought to Mexico.
A: Regulatory authorities are more efficient if they collaborate closely with their peers around the world,
Q: Considering how quickly technology evolves, how can
since the concerns are almost the same on all continents.
regulatory bodies keep pace?
The alignment of policies allows the simplification of
A: We have created a committee that evaluates new
processes and saves companies from having to perform
drugs and medical devices and provides support for their
the same clinical studies several times or to perform several
developers throughout the commercialization process.
plant reviews. In these cases, a revision from a Stringent
Investment in R&D carried out by other countries comes long
Regulatory Authority (SRA) should be sufficient. Among
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
Federal Commission for Protection Against Sanitary Risks
is a space for discussion among academia, regulators and
(COFEPRIS) monitors the production, commercialization,
the industry whose goal is to close any gaps in knowledge.
import, export and marketing of medications, medical devices,
Its ultimate goal, announced in March 2018, is the creation
insecticides, fertilizers, chemicals and makeup, among others
of a National Plan for Regulatory Sciences.
