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Welcome! This platform and blog focuses on regulatory affairs for pharmaceutical products in Latin American markets. We run this website because we believe that making information readily accessible for companies and entrepreneurs that want to explore new markets is a great way to promote those markets and push new investment into developing countries. This will not only help get their economies moving, but will also bring benefits to the public health.
If you want a quick insight on regulatory affairs in Mexico and Argentina, check out this slides that have been presented by María Inés Guaia in the 2013 Informa Conference on Regulatory Affairs in Emerging Markets, in Prague, October 2013.
If you need more details, you can explore the specialized sections.
For more material on Mexico regulatory affairs, go here
For more material on Argentina regulatory affairs, go here
Regulatory Affairs in Latin America 
Really informative information..
Excelentes contenidos!
Hi, do you have any information about Costa Rica?
Thanks in advance
Hi Selenne!
Thanks for your enquiry. Actually, I just started writing the section on Costa Rica and expect to have it ready in the following days. If you send me an email to maria@latampharmara.com I can send you some preliminary information (in Spanish) and let you know when I publish the finished content of your interest, in English, on this website.
Have a nice day! Thanks for visiting the site!
Maria
And about Panama? I would be very grateful!
Lucía
we are ISo 9001.2008 certified manufacturer of veterinary, human and poultry drugs and exports to many countries Saudi Arabia, Kuwait, Sri Lanka, Nigeria, Mauritania, Sudan, Mauritius, UAE, Ethiopia, Somalia, Guyana, Turkmenistan, Yemen, Lebanon, Niger, Mozambique and registration in many countries is in progress like Jordan, Yugoslavia, Chile and Myanmar.
so, kindly let me know the registration requirement, its timeline for approval and fee charges in Costa Rica for the same please write me back export1@starlabs.com.pk.
hope to hear from you soon.
Many Thanks for your kind co-operation in advance!!
Regards,
Salman Shahzad
Export Officer
Dear Mam
i want the guidelines of Ivory Cost please provide me
one place many things
Hello
Dear Maria,
A great reference of Latin America information!!! Congratulations on a nice job and keep it up. In return, if there are any Latin American companies that need information about the US Regulatory Affairs, please contact me at jlhinsonllp@gmail.com
James L. Hinson
Hi Maria! Can you please let me know the procedure of registering API’s with COFEPRIS including Audits and timeline for approval?
Thanks in advance.
Akash
Hi, can we get more information on El Salvador regulatory requirements and timeline? and for chile?
Useful information shared….I am very happy to read this article..Thanks for giving us nice info. Fantastic walk-through. I appreciate this post…Many Thanks!
Hello , Great information. Excellent work.
Can you also help us preparing these documents and register our company in Latin America?
RGds
Hola María, soy de Argentina y quería saber dónde puedo encontrar un modelo de CTD o mejor aun, uno ya hecho. Estudié Lic. en Biotecnología y necesito algo más concreto que lo que circula en las páginas de internet de ICH y FDA. Muchas Gracias! Delfina
Hello Defina,
I can not give you a copy of a full CTD because the ones I work on are proprietary. But if you have a question are would like advice about the US, please contact me.
Regards,
Jim Hinson
Hola!
Muchas gracias por este blog, lo estoy encontrando muy útil. Si me permites me gustaría preguntarte si para la autorización de marketing de nuevos fármacos es necesario la parte de Environmental Risk Assessment que es requerida por la EMEA o FDA (por ejemplo) en Latin América.
Muchas gracias,
Hiii Maria,
Great information very useful, can you please tell where can i get the list of medines which got market authorization in argentina till date. Please provide the llink if possible. Thanks in advance.