International Generic Drug Regulators Outline Plans for Collaboration Through 2020
By Zachary Brennan -
Published 09 January 2017
As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years.
Categories: News, Africa, Asia, Canada, Europe, US, Anvisa, CFDA, EC, EMA, FDA, Health Canada, ICH, Medsafe, MHLW, PMDA, TGA, WHO, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy
Tags: generic drug regulation, COFEPRIS, DMFs, ASMFs
International Medical Device Regulatory Update: News and Views From San Jose
By Randolph Fillmore -
Published 20 December 2016
Several sessions at the 2016 RAPS Regulatory Convergence, held in San Jose, California in September, focused on medical device regulations and regulatory changes worldwide. These included: FDA's establishment of a national evaluation system for medical devices, China's agreement to give imported medical devices the same treatment as those manufactured or developed domestically, Japan's reduced review time for medical devices over six years, Asia/Pacific's expected medical device market expansion and Mexico's increase in device submissions.
Categories: Features, Asia, Latin America and Caribbean, US, FDA, PMDA, Medical Devices, Submission and registration
Tags: National Evaluation System for Medical Devices, NEST, Precision Medicine, COFEPRIS
Mexico's COFEPRIS Exempts Hundreds of Devices from Registration Requirements
By Stewart Eisenhart -
Published 12 January 2015
Mexican regulators have expanded their list of healthcare products that do not require registration and approval to be sold in the country.
Categories: News, Latin America and Caribbean, Medical Devices, Submission and registration
Tags: COFEPRIS, Emergo, Emergo Group
New COFEPRIS Guidance on Technovigilance Report Submissions
By Stewart Eisenhart, Emergo Group -
Published 25 September 2014
Mexico’s medical device market regulator COFEPRIS has issued new guidance on its technovigilance reporting program (link in Spanish) for medical device manufacturers commercialized in the country.
Categories: News, Latin America and Caribbean, Medical Devices, Postmarket surveillance
Tags: Mexico, COFEPRIS, Technovigilance