Tagged with COFEPRIS

LatAm A roundup of some of the biggest stories coming out of Latin American pharma and healthcare, including Mexico’s move to speed up the drug review process; Sanfer’s acquisition of Columbia’s Laboratorio Vitalis; Pfizer’s joint vaccine effort with PAHO and Argentinian drugmaker Sinergium Biotech, and the epilspsy joint venture between SK Biopharmaceuticals…

Mexico With the naming of Armida Zuñiga as head of the country’s regulatory body COFEPRIS, new Mexican president Claudia Sheinbaum has concluded the new government’s healthcare appointments and begun advancing her agenda by tackling Mexico’s widespread medicine shortages.   New Regulatory Lead By the time Claudia Sheinbaum was sworn in as…

Mexico The lowest spender on healthcare as a percentage of GDP in mainland Latin America. A complex and fragmented reimbursement system. Clinical trial approval delays stretching across eight months. One could be forgiven for thinking that attempting to bring innovative medicines to Mexico is a thankless task. Yet, as several country…

LatAm An overview of some of the biggest news from Latin American pharma, including Onconic Therapeutics’ licensing deal with Laboratorios Sanfer for 19 LatAm countries; Lupin’s orphan drug partnership with Argentina’s Celnova Pharma; Grifols’ distribution deal with Gema Biotech; the downturn in Uruguay’s medicinal canibis industry, and Novartis’ increased clinical trial…

Mexico The election of populist President Andres Manuel Lopez Obrador (AMLO) on 1 July 2018 heralded a new era of hope and optimism for Mexicans. In the first 13 months of his term, he has made full use of his popularity. With enviable approval ratings consistently exceeding 60 percent, he has…

Mexico According to a recent World Health Organization study, countries must allocate at least six percent of their GDP to research and development to be considered to have a healthy investment in this area. As Mexico currently only invests 1.8 percent of its GDP into R&D, there is clearly still a…

Pharma Sandra Sánchez, General Manager at PROBIOMED, explains the crucial role that biosimilars will play in the future healthcare system as well as the importance of complying with COFEPRIS’ regulations to expand PROBIOMED’s business within the region. Last time we met with you, you explained that PROBIOMED was following a three…

Pharma Building on the continuous improvements of the Federal Commission for the Protection Against Sanitary Risk (Cofepris) over the last few years, its recently-appointed Federal Commissioner Julio Sánchez y Tépoz reveals his strategy to further strengthen and develop the Commission’s processes and international leadership, and foster a more transparent, technical, efficient…

cofepris The implementation of third authorized parties has been a very proactive effort implemented by Mexico’s regulatory authority Cofepris to expedite the time to issue sanitary registrations. The CEO of Entimem provides an overview about the system currently in place, the challenges faced as well as benefits such a system offers…

generics The CEO of DefiLatina Healthcare reveals how a reliance on social security has seen the public health system struggle to meet the demands placed upon it, how her company´s vision is to partner with the regulatory authorities, helping to increase the country´s access to medicines and why they were voted…

biotech The executive director and general manager of Amgen Mexico discusses how the company relies on Mexico as a hub for clinical research, with an investment of over USD 22 million since 2006, and strives to deliver its pipeline of innovative medicines to treat seriously ill patients in Mexico.   You…

biotech The executive director and general manager of Amgen Mexico discusses how the company relies on Mexico as a hub for clinical research, with an investment of over USD 22 million since 2006, and strives to deliver its pipeline of innovative medicines to treat seriously ill patients in Mexico.   You…