Comisión Federal para la Protección contra Riesgos Sanitarios

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MexicoMexico Comisión Federal para la Protección contra Riesgos Sanitarios
Cofepris logo.jpg
Supervisory authority (s) Secretaría de Salud
Consist Since July 5, 2001
Headquarters Mexico city
Coordinates 19 ° 23 '33.9 "  N , 99 ° 10' 29.7"  W Coordinates: 19 ° 23 '33.9 "  N , 99 ° 10' 29.7"  W.
Authority management José Alonso Novelo Baeza
Website www.gob.mx/cofepris
Seat of the Cofepris in Mexico City , Benito Juarez district

The Comisión Federal para la Protección contra Riesgos Sanitarios (German: Federal Commission for the Protection against Health Risks ), or Cofepris for short , is the Mexican health authority based in Mexico City . It reports to the Mexican Ministry of Health (SALUD) and is responsible for regulating products, activities, services and facilities in the Mexican health care system .

The controlled area includes manufacturing, placing on the market, importing and exporting food and beverages , tobacco products, health products such as drugs , medical devices , vaccines , biotechnology , blood and tissue preparations, etc., cosmetic / personal care products, pesticides and fertilizers , as well as health services, health protection in the workplace and towards environmental risks and advertising. With the goods and services regulated by the Cofepris, almost 10 percent of Mexico's gross domestic product is generated.

organization

tasks

The tasks of the Cofepris are laid down in the "General Health Law" ( Ley General de Salud ) of Mexico and include:

  • Recommendations for the Ministry of Health's policy on protecting against health risks in the areas of health facilities, pharmaceuticals and other health products (herbal products, dietary supplements ), medical devices , biotechnological products , food and beverages, cosmetics, tobacco products, pesticides, plant nutrients , raw materials and additives for the manufacture of the above-mentioned products, toxic or dangerous substances, and the prevention and control of harmful effects of environmental factors on human health, health at work and basic hygiene
  • Elaboration and publication of official standards with regard to products, activities and facilities in the health sector
  • Evaluation, granting or revocation of approvals required in the area of ​​responsibility, for example approvals for drugs ( drug approval ) and medical devices
  • Issuing official certificates for processes, products, methods, facilities, services or activities in the health sector
  • Control and monitoring of health products and the related activities, their import and export as well as the processing companies, monitoring of compliance with the regulations together with the executive
  • Determination of health risks (in the area of ​​responsibility of Cofepris)
  • Control and monitoring of advertising in the healthcare sector
  • Control and monitoring of the availability and transfer ( transplantation ) of organs, tissues and cells from humans
  • Imposing sanctions and ordering security measures within the jurisdiction.

Commissioners

The Commissioner (Head of Authority) is appointed by the Mexican President on the proposal of the Minister of Health .

  • Ernesto Enríquez Rubio (2002-2006)
  • Juan Antonio García Villa (2006-2008)
  • Miguel Ángel Toscano Velasco (2008–2011)
  • Mikel Andoni Arriola Peñalosa (2011-2016)
  • Julio Sánchez y Tépoz (2016-2018)
  • José Alonso Novelo Baeza (since 2018)

history

founding

The establishment of the Cofepris took place on the legal basis of the "General Health Act" ( Ley General de Salud ), Article 17a, as an autonomous and decentralized authority of the Ministry of Health and was announced on July 5, 2001 in the Official Gazette of the Mexican Federation. The Cofepris replaces the Subsecretaría de Regulación y Fomento Sanitario ("Undersecretariat for Regulation and Health Promotion").

Reform 2011

After almost 10 years of existence, Cofepris initiated a modernization process in March 2011 with the aim of improving its services and optimizing the approval process for drugs and other pharmaceutical and medical products. Irregularities and opaque procedures had made permit applications in Mexico an unsafe endeavor. In 2010, for example, only two novel drugs were approved.

By 2015, Cofepris had then undergone extensive redesign and modernization. The backlog of around 8,000 applications for market approval in recent years has been eliminated, pending legal updates have been issued and a comprehensive program to simplify administration, international harmonization and increased monitoring of hygiene has been implemented.

  • The processing of applications has been restructured, so that approval applications are no longer processed in the order in which they are received, but rather according to the type of application (new approval, extension, change) and according to product type and risk. "Authorized third parties" (Terceros Autorizados ) were involved in the initial processing of the application , which means that private or public organizations carry out an initial assessment ("pre-approval"), which the authority takes into account for its own subsequent assessment process. In addition, accelerated procedures have been created for such applications (" fast-track procedure").
  • The “Agreement to Promote Innovation” concluded in 2012 allows Cofepris to use an accelerated procedure to approve drugs with new active ingredients that have already been registered by the drug authorities in the USA, EU, Australia, Canada or Switzerland. An "equivalence agreement" agreed with the USA, Canada and Japan for medical devices recognizes the necessary tests and assessment procedures in these countries as equivalent to the Mexican ones, which makes it easier to obtain marketing authorization. The two-stage exemption from the registration requirement for a total of over 2200 medical devices classified as harmless has further lowered barriers to market entry.

After the regulations for biotechnological medicinal products issued in 2013 turned out to be insufficient, they were revised in 2015 to take into account the need for stricter requirements for biosimilars .

The “5/15 program” from 2016

In 2016, Cofepris presented the “5 principles and 15 measures to protect against health risks” program. It is based on the five pillars of ethics , transparency , mechanization , efficiency and competitiveness and serves to protect the health of the Mexican population. The program envisaged an expansion of the information and advisory services for citizens and an intensification of general hygiene monitoring . The simplification and deregulation of approval procedures and the creation of regulatory guidelines for companies in the economically important sectors of food, pharmaceuticals and chemicals should support the dismantling of barriers to market entry and thus further improve the availability of health products. Measures to strengthen clinical research in Mexico, the national pharmacovigilance system and the surveillance of illegal products addressed aspects of safety. Other program items included the establishment of a Cofepris competence center, acceptance into the Pharmaceutical Inspection Co-operation Scheme (PIC / S), recertification by the Pan-American Health Organization (PAHO) and the modernization of the laboratories of the Quality Control Commission ( Comisión de Control analítico y Ampliación de Cobertura , CCAYAC).

Regulatory Affairs

In 2011, Cofepris issued the first drug approval for a foreign pharmaceutical company . The obligation for pharmaceutical companies to have a production facility in Mexico in order to be allowed to market in the country was abolished by a change in the law in 2008, which significantly increased the potential for the pharmaceutical industry.

The reforms introduced in 2011 also significantly improved the situation for drug approval. The Mexican Association of the Research- Based Pharmaceutical Industry ( Asociación Mexicana de Industrias de Investigación Farmacéutica , Amiif) commented positively on the development at the beginning of 2017 and pointed out that 214 drugs with new active ingredients were among the approvals of the previous four years. By the end of 2018, the number had grown to 370. A large number of generics have also been approved since 2011.

In 2015, Mexico became the first country in the world to approve a dengue virus vaccine ( Dengvaxia ) to prevent dengue fever .

Further modernizations in recent times concern the electronic submission of applications, further powers for the “authorized third parties” and new provisions for the “Committee for New Molecules” ( Comité de Moléculas Nuevas , CMN), which deals specifically with novel active substances.

International recognition and cooperation

The Mexican authorities Cofepris and SENASICA signed an agreement with the US FDA in the field of food safety in 2014

In 2012, on the recommendation of the World Health Organization (WHO) , the Pan American Health Organization (PAHO) certified Cofepris as the so-called National Regulatory Authority (NRA) of Regional Reference , an award for regulatory competence in the pharmaceutical sector. As a result, approvals issued by Cofepris can be recognized in the seven Latin American countries (as of 2016) Ecuador , El Salvador , Colombia , Chile , Costa Rica , Panama and Belize . In 2014 it was accredited as a Functional National Regulatory Authority by the WHO, giving Mexico a regulatory stake in the global vaccine supply and thus contributing to the worldwide elimination and eradication of communicable diseases. Initially designed for a three-year period, the certification was extended in 2017. The exercise of such a function is linked to certain prerequisites, such as the existence of defined approval requirements for vaccines, a system for batch-related release, a pharmacovigilance system , usability of analytical laboratories, regular GMP inspections of the vaccine manufacturers and monitoring of clinical studies with vaccines.

The awards are also significant against the background of Cofepris' participation in international cooperation projects such as the "Interinstitutional Agreement between the Health Authorities of the Pacific Alliance " and memberships such as the International Coalition for Medicines Regulatory Authorities (ICMRA) or the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), which Mexico joined as an observer country in 2016. Effects are also seen with a view to promoting the domestic vaccine industry.

2018 was admitted COFEPRIS in the PIC / S .

Web links

Individual evidence

  1. ↑ a b c Ley General de Salud, Article 17a, on mexico.justia.com , accessed February 14, 2020.
  2. ↑ COFEPRIS recibe reconocimiento por recetario médico electrónico , Cofepris, November 30, 2018.
  3. ↑ Nombra nuevos funcionarios el Secretario de Salud, Jorge Alcocer Varela , Cofepris, December 6, 2018.
  4. ↑ F Dr. José Alonso Novelo Baeza , Secretaría de Salud (SALUD), accessed February 14, 2020.
  5. ↑ Decreto por el que se crea la Comisión Federal para la Protección contra Riesgos Sanitarios , Diario Oficial de la Federación, July 5, 2001 ( digitized version ) .
  6. ↑ The medical technology market in Argentina, Brazil, Chile and Mexico. Germany Trade & Invest (GTAI), Bonn, October 2011. P. 83 ( PDF ).
  7. ↑ a b COFEPRIS: Using regulation to Better Protect the Population's Health and Transform the Market 2015 , Alliance Magazine, United States Chamber of Commerce (USCOM), December 17, 2015.
  8. ↑ MAA Peñalosa, RC Cepeda, MA Garza, et al .: Optimized Medical Product Regulation in Mexico: A Win-Win for Public and Economic Health . Ther Innov Regul Sci, Volume 51, Issue 6, 2017. pp. 51-744. doi : 10.1177 / 2168479017701503
  9. ↑ R. Luigetti et al .: Regulatory collaboration . WHO Drug Information, Volume 30, No. 4, 2016 ( PDF )
  10. ^ MT Tello: Mexico Fast-Tracks Medical Device Approval , Medical Product Outsourcing (MPO), July 2, 2011.
  11. ↑ German-Mexican Chamber of Commerce and Industry: Target Market Analysis Healthcare - Modernization of Mexican Healthcare Facilities , Federal Ministry for Economic Affairs and Energy (ed.), April 2017 ( PDF ).
  12. ^ A. Luna et al .: Latest developments in biologic and biosimilar regulation . Managingip.com, November 2015 PDF .
  13. ↑ Mexico issues rules on biolimbos , Generics and Biosimilars Initiative (GaBI), March 13, 2015.
  14. ↑ Presenta la Cofepris Programa 5/15 a la Coparmex , Cofepris, April 13, 2016.
  15. ↑ Julio Sánchez y Tépoz (Cofepris): 5 principios y 15 acciones para la Protección contra Riesgos Sanitarios , accessed on February 14, 2020.
  16. ↑ A. Azcatl: marketing authorization for pharmaceutical products to foreign Applicants , Managing Intellectual Property Magazine, on www.olivares.mx June 2011th
  17. ↑ rafaelbuenobalderas: AMIIF celebrará III Semana de Innovación en Salud , notiexposycongresos.com, March 27, 2017.
  18. ↑ R. Rojas: COFEPRIS autorizó 370 medicamentos Innovadores durante el Sexenio de EPN , Saludario 30 November 2018th
  19. ↑ Estrategia de Liberación de Medicamentos de Genéricos para el Ahorro de las Familias , revistacofepris.salud.gob.mx, accessed on February 14, 2020.
  20. ↑ Mexico approves dengue vaccine , Deutsche Apothekerzeitung , December 17, 2015.
  21. ^ F .: Changed framework conditions on Mexico's pharmaceutical market , Germany Trade & Invest (GTAI), May 4, 2017.
  22. ↑ PAHO Recognizes COFEPRIS as a National Regulatory Authority of Regional Reference Pan American Health Organization, July, 2nd 2012th
  23. ↑ a b L. Belgharbi .: Mexico as a Global Reference on Health Issues , Revista Cofepris, accessed on February 14, 2020.
  24. ↑ La COFEPRIS se como revalida Autoridad Nacional de Medicamentos regulators Dora nivel IV , La Revista de Canifarma, December 21, 2017th
  25. ↑ La COFEPRIS participó en la Reunión de la Coalición Internacional de Agencias Reguladoras , www.gob.mx/cofepris, June 27, 2016.
  26. ↑ A. Diaz: Regulará la COFEPRIS Vacunas de 2014 a 2017 , Quadratin, August 14, 2014.
  27. ↑ México inicia 2018 como integrante formal de PIC / S , www.gob.mx/cofepris, January 1, 2018.