Mexico seeks entry into pharma practices agreement

PharmaMexico’s pharmaceutical industry has been performing well in recent years.  Both multinational subsidiaries and domestic manufacturers are targeting booming maladies like obesity and diabetes, and taking advantage of the relatively low cost of clinical testing and R&D.  But as private sector manufacturers make headlines investing in flashy new laboratories, The Mexican government has been quietly pursuing a regulatory initiative that may soon make an important impact on pharmaceutical manufacturing in the country.

In 2014, Mexico’s Federal Commission for the Protection Against Sanitary Risks, or Cofepris, applied for entry into the Pharmaceutical Inspection Co-operation Scheme, or PIC/S.  The PIC/S scheme is an international agreement on good manufacturing and plant inspection practices for medicinal products currently composed of the regulatory bodies of 48 countries around the world.  As part of its effort to be admitted to the agreement, earlier this year Mexico updated regulatory standards (NOMs) in areas such as pharmaceutical quality management, sterile product manufacturing practices, control over subcontracting and others.  The benefits of becoming an approved PIC/S member, Mexican officials say, will include eliminating the need for foreign regulatory bodies to inspect Mexican drug plants individually for export approval, helping to reduce costs and open the door to increased Mexican exports.  Lowering the cost of inspections overall is also expected to help bring down domestic drug prices for consumers.  Officials also anticipate that facilitating exports and lowering inspection costs will drive an increase in foreign direct investment in drug manufacturing in Mexico.

Local media at times give the impression that Mexico already has achieved entry into PIC/S, perhaps due to imprecise statements by government officials.  Nonetheless, Cofepris has not yet been formally admitted to the agreement.  Following a PIC/S inspection visit to Mexico in January 2016, Mexican regulatory officials reported that approval was likely to be imminent, however a PIC/S official bulletin in July 2016 indicated that evaluators had reported outstanding issues to Cofepris that would still need to be addressed to move forward.  A PIC/S spokesperson confirmed to Mexico Business Blog via email in August 2016 that Mexico’s status has not yet been changed from “Applicant” to “Member.”  The Mexican government is hoping that PIC/S approval over the next year will combine with entry into effect of the proposed Trans-Pacific Partnership in the near to medium term to generate significant growth opportunities for the domestic pharmaceutical manufacturing industry.  For both economic and health reasons, we hope this turns out to be true.

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