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Category Archives: Mexico
COFEPRIS+MercadoLibre: agreement to regulate advertisement
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 … Continue reading
Posted in Mexico
Tagged advertisement, agreement, COFEPRIS, collaboration, drug products, e-commerce, health authority, health supplies, MercadoLibre, Mexico, regulatory affairs
1 Comment
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 … Continue reading
Posted in Mexico, South Korea
Tagged COFEPRIS, Cooperation, drug products, health supplies, Mexico, Mikel Arriola, regulatory affairs, South Korea, South-South Cooperation
2 Comments
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 … Continue reading
Posted in Mexico
Tagged Clinical Investigation, clinical trials, COFEPRIS, CTA, Decentralization, regulatory affairs
1 Comment
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 … Continue reading
Posted in Mexico
Tagged COFEPRIS, drug products, generics, health authority, Mexico, Mikel Arriola, regulatory affairs
1 Comment
Movies for regulatory professionals: Dallas Buyers Club (2013)
This 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 … Continue reading
Posted in Mexico, RA in Popular Culture, USA
Tagged AIDS, clinical trials, ethics, FDA, movie, popular culture, regulatory affairs
1 Comment
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 … Continue reading
Posted in Argentina, Brazil, Canada, Colombia, Cuba, Mexico, Uncategorized, USA
Tagged ANMAT, anvisa, Argentina, brazil, Canada, CECMED, COFEPRIS, Colombia, Cooperation, Cuba, drug products, FDA, health authority, Health Canada, Latin America, Mexican Health Agency, Mexico, Mikel Arriola, National Regulatory Agency of Regional Reference, PAHO, Pan American Health Authorization, regulatory affairs
2 Comments
Mexico at the vanguard with new combination drug
In the past days, COFEPRIS granted approval for the combination drug containing fluticasone furoate and vilanterol, indicated for treatment of chronic obstructive pulmonary disease (COPD) and asthma. Although the product had already been approved in the US by the FDA in … Continue reading
MoU between Mexican and Chinese health authorities
In the framework of the bilateral agreements recently signed by the presidents of Mexico and China, Enrique Peña Nieto and Xi Jinping, respectively, the representatives of both sanitary agencies, subscribed the first Memorandum of Understanding to strengthen cooperation in matters … Continue reading
Posted in China, Mexico, Uncategorized
Tagged CFDA, COFEPRIS, Cooperation, drug products, Harmonization, health supplies, Memorandum of Understanding, Mexico, Mikel Arriola
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Mexico and Costa Rica sign cooperation agreement on drugs and vaccines
On the 17th of October 2013, COFEPRIS issued a press release informing on a new agreement of cooperation between the health authorities of Mexico and Costa Rica that will allow the recognition of drug registrations approved by COFEPRIS, by Costa … Continue reading
Mexico: new guidelines for the acceptance of GMP certificates
In October 2013, the Mexican health authority released a new document setting the criteria that will be used to accept GMP certificates as valid. This criteria applies to certificates of manufacturing facilities both of finished products and API. Summary of … Continue reading
Posted in Mexico
Tagged COFEPRIS, GMP, GMP certificate, Good Manufacturing Practices, health authority, inspecitions, Latin America, Mexico, regulatory affairs
6 Comments
Regulatory Affairs in Latin America 