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- Regulatory Affairs in Emerging Markets
- Fundamentals of Regulatory Affairs
- ANMAT: the Argentinean Health Authority
- Drug registration in Argentina
- Registration of biological drug products in Argentina
- First batch verification
- Drug product certificate renewal in Argentina
- Orphan drug regulation
- GMP inspections: regulatory aspects
- Central America
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Category Archives: Uncategorized
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.
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. http://www.imdb.com/title/tt2084832/ It can be … Continue reading
Market access interview!
Top 10 Pharma – products in the pipeline
Did you know that you can consult which new innovations are in the pipelines of the top 10 pharma companies directly from their websites? Have a look! 1- Johnson&Johnson 2- Pfizer 3- Novartis 4- Sanofi 5- Merck&Co 6- GlaxoSmithKline 7- Abbott … Continue reading
Posted in Uncategorized Tagged big pharma, pipeline 1 Comment
Puerto Rico to ‘opportunistically pursue’ biologics to regenerate industry
Puerto Rico to ‘opportunistically pursue’ biologics to regenerate industry.
Posted in Uncategorized 1 Comment
Argentina: Site Master File now required by ANMAT for national sites
Starting on November 19th, 2o13, sites in Argentina approved by ANMAT to manufacture or package, in own or contract facility, or import or export, both drug products and APIs, have to submit their Site Master Files (SMF) annually. This is … Continue reading
Posted in Argentina, Uncategorized Tagged Active Pharmaceutical Ingredients, ANMAT, API, Argentina, drug products, electronic submission, GMP, Good Manufacturing Practices, inspections, Latin America, National Regulatory Agency of Regional Reference, new Disposition, regulatory affairs, Site Master File, SMF 2 Comments
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 Leave a comment
Argentina: checklist for GMP inspections of API facilities
On the 3rd of September 2013, ANMAT (regulatory agency in Argentina) issued a new Disposition establishing the guidelines and checklists that will be used by its inspectors for GMP inspections of sites of manufacturing, elaboration, fractionating, distribution, commercialization, exports and imports … Continue reading
Posted in Argentina, Uncategorized Tagged Active Pharmaceutical Ingredients, ANMAT, API, Argentina, GMP, ICH guidelines, new Disposition Leave a comment
Starting right now, we have a brand-new nice domain for our regulatory affairs information site and blog: LatAmPharmaRA.com So exciting! Come by anytime!