Pharmaceutical Drug Product Registration and Requirements in Latin American Countries

Authors

  • Bengre P. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India
  • Dixit M. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India
  • Charyulu R.N. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India
  • Shetty A. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India
  • Rao M.S. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India
  • Thomas S. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India

DOI:

https://doi.org/10.37591/rrjodfdp.v1i3.319

Abstract

 

The regulatory process to obtain marketing authorization’s (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonization efforts, is highly country-specific. This article offers a practical overview of product registration processes in LATAM. Although the International Conference on Harmonization (ICH) Common Technical Document (CTD) can serve as a resource for most local MA applications, it is not necessarily required in its full length. Additionally, a significant amount of mandatory and highly country-specific documentation (related to infrastructure, legal documents, stability studies, labelling, etc.) require strategic planning and allocation for successful and timely local approvals. Exhaustive identification of actual requirements can present challenges due to frequent changes in regulations, unclear expectations, etc. Having as much early visibility and command of the LATAM country-specific requirements and health authorities’ (HAs) expectations will help the pharmaceutical industry to improve planning for global MA applications, optimally manage internal expectations, and most importantly give patients in the region faster access to therapies and better quality of life.

 

Keywords: Latin America (LATAM),  Common Technical Document (CTD),  Certificate of Pharmaceutical Product (CPP), Certificate of Medicinal Product (CMP), Chemistry, manufacturing and controls (CMC)

Downloads

Published

2019-02-26

Issue

Vol. 1 No. 3 (2014)

Section

Review Article

License

Declaration and Copyright Transfer Form

(to be completed by authors)

I/ We, the undersigned author(s) of the submitted manuscript, hereby declare, that the above manuscript which is submitted for publication in the STM Journals(s), is not published already in part or whole (except in the form of abstract) in any journal or magazine for private or public circulation, and, is not under consideration of publication elsewhere.

  • I/We will not withdraw the manuscript after 1 week of submission as I have read the Author Guidelines and will adhere to the guidelines.
  • I/We Author(s ) have niether given nor will give this manuscript elsewhere for publishing after submitting in STM Journal(s).
  • I/ We have read the original version of the manuscript and am/ are responsible for the thought contents embodied in it. The work dealt in the manuscript is my/ our own, and my/ our individual contribution to this work is significant enough to qualify for authorship.
  •  I/We also agree to the authorship of the article in the following order:

Author’s name                                    

 

1. ________________

2. ________________

3. ________________

4. ________________

 

We  Author(s) tick this box and would request you to consider it as our signature as we agree to the terms of this Copyright Notice, which will apply to this submission if and when it is published by this journal.