COFEPRIS+MercadoLibre: agreement to regulate advertisement

MercadoLibre logo

MercadoLibre’s logo

 On the 22nd of March, 2014, the COFEPRIS, representing the Mexican Secretariat of Health, has signed a collaboration agreement with the e-commerce company “Mercado Libre” of México. The agreement, signed by the COFEPRIS Federal Commissioner Mikel Arriola, and the general director of MercadoLibre in Mexico, Francisco Ceballos, seeks to eliminate non-authorized advertisement of healthcare products, to protect Mexican consumers and their health.

Some of the goals of the agreement are: reducing the commerce of “miracle” products through MercadoLibre, preventing self-medication and discontinuation of medical treatments, and regulating the diffusion of advertisement messages in a high-growth and high-impact medium.

With a direct channel of communication between COFEPRIS and MercadoLibre, the health authority seeks to avoid that publications of products that have already been banned are reposted in the website. The agreement will facilitate information exchange so that the health authority can carry on investigations and execute actions to prevent healthcare risks.

In exchange, COFEPRIS will expedite the issuance of advertisement authorizations for products and services that promote health and comply with the sanitary regulations. In addition, it will provide MercadoLibre with constant advice on how its announcers can comply with the regulations.

In the last three years, the health authority has suspended more than 5,400 internet websites offering products and services and not complying with the regulations.

MercadoLibre is currently Latin America’s number-one e-commerce site, and eighth in the world.

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Mexico and S. Korea: pharma cooperation agreement

On Tuesday 11th March 2014, the COFEPRIS, Mexico’s regulatory authority, and the South Korean Ministry of Health and Wellbeing, through their representatives, signed a collaboration agreement on matters of regulatory affairs for drug products, cosmetic products and medical devices.

The Memorandum of Understanding was signed at the COFEPRIS headquarters in Mexico by the head of the COFEPRIS, Commissioner Mikel Arriola, and the Deputy Minister of Health Policy of South Korea, Choi Younghyun. Also present in the meeting were the South-Korean Vice-Minister of Food and Drug Safety, Jang Byungwon, representatives of the Ministry of Foreign Relations and of the pharmaceutical industry of South Korea, and officers of the Mexican Ministry of Health.

The goal of the agreement is to reinforce the technical and scientific cooperation for the benefit of the health of both countries’ populations. The authorities also agreed to work on international cooperation and pharmaceutical innovation to boost their respective economies.

Heads of the Mexican and South Korean Health Authorities signing the Memorandum of Understanding. Photo credit: COFEPRIS website.

Heads of the Mexican and South Korean Health Authorities signing the Memorandum of Understanding. Photo credit: COFEPRIS website.

In the occasion, Mikel Arriola stated that to face the challenge of expanding access to more and better healthcare options for Mexicans, the government is broadening its cooperation ties with innovative countries such as South Korea. He highlighted that both countries are committed to investing in more research and development of products in the benefit of human healthcare.

The Minister Younghyun expressed his hope that this agreement will prove fruitful to both countries with regards to healthcare matters, and will strengthen the bilateral cooperation. He highlighted that, thanks to its technologic innovation policy, South Korea can produce drug products and medical devices at very low costs for the local population, which could also be exported to Mexico in an expedite way if the Mexican healthcare system requires them.

The Vice-Minister of Food and Drug Safety of the Asian country, Jang Byungwon, praised the Agreement for Innovation established by COFEPRIS to attract to Mexico, in the short term, the latest drug products for the treatment of severe chronic diseases.

The concrete impact of the encounter in the countries’ relations will remain uncertain until the legal frameworks are modified to include the mutual preferential treatment proposed in the agreement.

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Clinical Trial Applications in Mexico: decentralization and acceleration of protocol approval

With the goals of accelerating the development of new molecules that improve the healthcare and quality of life of Mexicans, and of stimulating clinical investigation, pharmaceutical innovation and foreign investment in the country, on the 5th of March 2014, the COFEPRIS has authorized the eight National Institutes of Health and the High-Specialty Hospitals Coordinating Commission to pre-approve clinical investigation protocols.

clinical trial phases

Once the Institutes pre-revise the clinical protocol, it would take the COFEPRIS about 20 working days to grant the final approval. This decentralizing action is expected to reduce the total approval timelines to just a month: a third of what it takes today.

During the official designation of the entities, Mikel Arriola, head of the COFEPRIS said: “This is a great window of opportunity. We want more investigation in Mexico, in Mexican patients, we want more and better treatments to be developed and we wantbig pharma companies to invest more in investigation and innovation, taking advantage of the scientific excellence of the Institutes”. He also clarified that this decentralization don’t transfer regulatory functions, given that the last word on the approval of the protocols will stay with the COFEPRIS.

The nine public institutions that have been assigned as Authorized Third Parties to pre-revise clinical protocols are:

  • Instituto Nacional de Cancerología. (National Institute of Cancerology)
  • Instituto Nacional de Cardiología. (National Institute of Cardiology)
  • Instituto Nacional de Ciencias Médicas y Nutrición. (National Institute of Medical Sciences and Nutrition)
  • Instituto Nacional de Rehabilitación. (National Institute of Rehabilitation)
  • Instituto Nacional de Neurología y Neurocirugía. (National Institute of Neurology and Neurosurgery)
  • Hospital Infantil de México. (Mexico Children Hospital)
  • Instituto Nacional de Salud Pública. (National Institute of Public Health)
  • Instituto Nacional de Enfermedades Respiratorias. (National Institute of Respiratory Diseases)
  • Comisión Coordinadora de Institutos Nacionales de Salud y Hospitales de Alta Especialidad. (High-Specialty Hospitals Coordinating Commission)

The remaining five institutes and high-specialty hospitals will be able to join the scheme automatically and immediately.

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Generic Market in Mexico up to 84%

The volume of generic drug products consumed by the Mexican population grew from 54% to 84% in the last three years, was announced by Mikel Arriola, Commissioner for the COFEPRIS, the Mexican regulatory agency. The announcement was made at the opening of a training session on marketing authorization of allopathic medicines of the Interchangeable Generic Drug Product Manufacturers Mexican Association (Asociación Mexicana de Fabricantes de Medicamentos Genéricos Intercambiables – AMEGI).

Dr. Arriola highlighted that Mexico is a the world leader in generic drug consumption, and that the Mexican people has overcome the myth that generic products are of poorer quality, safety and efficacy profile than those offered by innovative brands. He also mentioned that, thanks to expedite approval of these products, considerable savings are possible, both of out-of-pocket medicines expenditure, and public healthcare costs. Generic products now represent 52% of market share, the remaining 48% corresponding to innovatives.

In the last 29 months COFEPRIS has approved 261 generics of 29 APIs that lost market exclusivity of intellectual property protection.

Regarding administrative streamlining, on February 7th a new “Documental Checklist” system was implemented for marketing authorization applications, in which the content of the dossier is quickly inspected at the moment of submission to assure completion of information and documents. The need for this system was evidenced at noticing that 90% of the applications produced deficiency letters for lack of information. Now dossiers have to “tick all the boxes” to be admitted for revision.

In the last couple of years, COFEPRIS hasn’t speared efforts to increase the market share of generic drug products in Mexico. Actions included strengthening and clarification of the understanding of intellectual property rights, collaborations with the industry, administrative streamlining and education of the population. To illustrate this last point, here are some videos aimed to promote the choice of generics at the time of buying generics. (in Spanish)

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Movies for regulatory professionals: Dallas Buyers Club (2013)

dallas buyers clubThis is a movie I found especially interesting and enjoyable as a regulatory affairs professional, both because of the historical perspective, and because of the ethical and philosophical exercise of thought it brings.

Dallas Buyers Club is a 2013 American biographical drama film, directed by Jean-Marc Vallée and scripted by Craig Borten and Melisa Wallack. Matthew McConaughey stars as the real-life AIDS patient Ron Woodroof, who smuggled unapproved pharmaceutical drugs into Texas when he found them effective at improving his symptoms, distributing them to fellow sufferers by establishing the “Dallas Buyers Club” while facing opposition from the Food and Drug Administration (FDA).

It deals with the topics of homophobia and prejudices of AIDS in the middle 80’s, ethics of double-blind clinical trials against placebo in terminal patients, and the sensitive search of a balance between the urgent demand of cures in the market, and the need of a deeper understanding of safety and efficacy profiles before regulatory approval.

I hope you enjoy this movie as much as I did, and look forward to knowing what you thought of it. Have a great day!

Posted in Mexico, RA in Popular Culture, USA | Tagged , , , , , , | 1 Comment

Gates Foundation Says New Efforts Needed to Bolster Pharmacovigilance Systems in Developing World

Gates Foundation Says New Efforts Needed to Bolster Pharmacovigilance Systems in Developing World.

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INVIMA+ANMAT: inter-agency collaboration activities

During the last Summit of Regulatory Authorities of Regional Reference that took place in Acapulco, Mexico, on the 10th to 21st of February, the representatives of Colombia’s INVIMA and Argentina’s ANMAT, Dr. Blanca Elvira Cajigas de Acosta and Dr. Carlos A. Chiale, respectively, found the time to meet and sign a bilateral cooperation agreement between the agencies.

The memorandum of understanding stated the following objectives:

  • To promote the exchange of information and development of collaboration activities between the agencies, in order to strengthen their regulatory capacities.
  • To facilitate the exchange related to the drug traceability program and its Good Traceability Practices protocols.


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Americas Health Authorities Meeting

On the 20th and 21st of February of 2014, representatives of the five Latin-American Health Authorities of Regional Reference recognized by the Pan American Health Organization, plus those of the FDA, Health Canada, and El Salvador’s regulatory agency met in Acapulco, Mexico, for a Summit of Health Authorities.

The topics of the agenda were regulation harmonization, reduction of transaction costs, and facilitation of access to drug products and vaccines of high quality and low cost.

Representatives of the American Health Authorities. Photo: COFEPRIS website.

Representatives of the American Health Authorities. Photo: COFEPRIS website.

The Health Authorities certified as of Regional Reference currently are those of Mexico (COFEPRIS), Argentina (ANMAT), Colombia (INVIMA), Brazil (ANVISA) and Cuba (CECMED). During the meeting, the representatives of FDA and Health Canada announced their decision to seek the PAHO certification for their own institutions.

The recognition will follow an evaluation of the agencies’ performance of basic functions, recommended by WHO, for ensuring the quality, safety and efficacy of medicines in their countries. For more information on the System for Evaluation of the National Regulatory Authorities for Medicines, please refer to the PAHO website.

The regulatory agencies agreed to work together on three main tenants in 2014:

  • Strengthening of the regulatory capacity of the group: exchange of site inspection and drug product reports to avoid duplicate work, acceleration of marketing authorization approval for drug products, and reduction of barriers for new molecules to enter the markets, with the aim of reducing costs.
  • Increase of technical cooperation to support other agencies in the region and invite other countries to be observers of the group.
  • Design and implementation of a communication strategy for all involved parties to stay current on the progress of the consolidation of the Health Authorities network.

The agreements were signed by Mikel Arriola (Mexico), Rafael Pérez Cristiá (Cuba), Carlos Alberto Chiale (Argentina), Ana Paula Soares (Brazil), Blanca Elvira Cajigas (Colombia), Howard Sklamberg (USA) and Cathy Parker (Canada).

The next meeting of the group will take place next September in Washington, DC. 

Posted in Argentina, Brazil, Canada, Colombia, Cuba, Mexico, Uncategorized, USA | Tagged , , , , , , , , , , , , , , , , , , , , , | 2 Comments

Recommended movie: Fight to Live (2012)

The documentary FIGHT TO LIVE follows the pursuit of emerging cures for terminal diseases as told through the stories of patients, patient advocates and the companies who stake their future on the discovery of new treatments. It can be rented in iTunes for a low price.

Without taking a side in the debate, I recommend this film to all my regulatory affairs colleagues. It made me reflect about the delicate relation between health agencies and pharma companies wanting to assure superior efficacy and an acceptable safety profile, and patients needing urgent solutions to live or improve their quality of life.

It’s easy to lose the connection between what we do at the office every day and the patients at the other end. This week, let’s remember our patients and work for them.


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Market access interview!

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