Regulatory Affairs in Emerging Markets


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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

18 Responses to Regulatory Affairs in Emerging Markets

  1. Sanjay says:

    Really informative information..

  2. Guillermina says:

    Excelentes contenidos!

  3. Selenne says:

    Hi, do you have any information about Costa Rica?
    Thanks in advance

    • Maria says:

      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 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!


      • Lucía says:

        And about Panama? I would be very grateful!


      • 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

        hope to hear from you soon.
        Many Thanks for your kind co-operation in advance!!

        Salman Shahzad
        Export Officer

      • Kamal says:

        Dear Mam

        i want the guidelines of Ivory Cost please provide me

  4. lokesh reddy m says:

    one place many things

  5. Dahee Oh says:


  6. James L. Hinson says:

    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
    James L. Hinson

  7. Akash says:

    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.


  8. Aarti says:

    Hi, can we get more information on El Salvador regulatory requirements and timeline? and for chile?

  9. 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!

  10. Naveed Qadir says:

    Hello , Great information. Excellent work.

    Can you also help us preparing these documents and register our company in Latin America?


  11. María Delfina Bocco says:

    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

    • Jim Hinson says:

      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.

      Jim Hinson

  12. María says:


    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,

  13. amrutha says:

    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.

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