COFEPRIS Vows to Guarantee Regulatory Certainty
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COFEPRIS Vows to Guarantee Regulatory Certainty

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Sofía Garduño By Sofía Garduño | Journalist & Industry Analyst - Tue, 01/17/2023 - 16:27

COFEPRIS introduced the 2023 Strategy for Regulatory Certainty in the Pharmaceutical Sector to improve communication between the authority and those it regulates. Through seven measures, COFEPRIS expects to make the pharmaceutical industry more competitive, while guaranteeing access to medicines to the Mexican population. 

 

“We seek to eliminate obstacles and consolidate digitization and regulatory harmonization. Above all, the document will guarantee access to safe and quality health supplies,” wrote Alejandro Svarch, Federal Commissioner, COFEPRIS, on the document. 

 

Actors of the health industry had urged COFEPRIS to deploy actions to increase legal certainty to promote innovation and attract foreign investment to Mexico. “There is a gray area where we have to guess and try to communicate with COFEPRIS to create a regulatory pathway, said Cristina Campero, CEO, PROSPERiA, during MHS 2022. With the recently published strategy, COFEPRIS expects to improve communication, helping the country exploit its potential and enable an environment for scientific innovation in healthcare. 

 

“Regulatory certainty means working to facilitate the maximum possible clarity between the regulator and the regulated to avoid the generation of spaces conducive to corruption. It is to comply with goals and commitments that allow us to rebuild a health system led by the State that does not protect individual interests,” writes Jorge Alcocer, Mexico’s Minister of Health, in the document.

 

COFEPRIS treats regulatory certainty as full compliance with the regulatory framework for the protection against health risks. To achieve it, COFEPRIS will commit to the installation of the Committee on Good Regulatory Practices to ensure coherence in regulatory changes. COFEPRIS adds that it will authorize medicines by recognizing the decisions of other regulatory authorities. 

 

Regulatory harmonization and digitalization will continue to be a priority, reads the document. Digitalization has been one of COFEPRIS’s priorities, as the organization recently introduced DIGIPRIS to make its processes more efficient. “COFEPRIS has made an effort to reduce this bottleneck, including the digitalization and request for resubmission of term extension petitions for drug products,” writes Juan Luis Serrano, Partner Life Science, Sanchez Devanny Eseverri, on MBN.

 

Moreover, COFEPRIS will include NOM-177 in the Supplement to the National Quality Infrastructure Program 2023 to guarantee full recognition of bioequivalence and biosimilarity studies conducted in countries with the same or higher criteria than Mexico. Finally, COFEPRIS will guarantee the safe use of Active Pharmaceutical Ingredients (API) and work to provide certainty for the accreditation of Good Manufacturing Practices (GMP) of low-risk drugs when there are no GMPs or equivalent documents issued by High Surveillance Regulatory Agencies.

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