Photo Gallery

Login

Search

News & Updation

  • Updated Version
  • WJPPS introducing updated version of OSTS (online submission and tracking system), which have dedicated control panel for both author and reviewer. Using this control panel author can submit manuscript
  • Call for Paper
    • WJPPS  Invited to submit your valuable manuscripts for Coming Issue.
  • Journal web site support Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Saffari for easy download of article without any trouble.
  •  
  • WJPPS Impact Factor
  • Its our Pleasure to Inform you that WJPPS Impact Factor has been increased from  7.454 to 7.632  due to high quality Publication at International Level

  • ICV
  • WJPPS Rank with Index Copernicus Value 84.65 due to high reputation at International Level

  • WJPPS: SEPTEMBER ISSUE PUBLISHED
  • SEPTEMBER 2021 Issue has been successfully launched on 1 September 2021.

Abstract

THE STATUS QUO OF REGULATORY PROCESS IN LATAM COUNTRIES: A REVIEW.

J. Balasubramanian*, K. Saisugathri, G. Sai Prasanna Lakshmi, G. Adhinarayana,
G. A. Nandhini

ABSTRACT

The regulatory process to obtain marketing authorisations (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonisation efforts, is highly country-specific. Complex and evolving ad-hoc requests from reviewers must be proactively addressed to avoid costly delays or show-stoppers to local product launches. This article offers a practical overview of product registration processes in LATAM, resulting from more than a decade of experience in a biotech company, to ensure successful global regulatory strategy. Although the International Conference on Harmonisation (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. It is vital for pharmaceutical industry to cope with the regulatory requirements for betterment of public and to ensure their place in the market.

Keywords: LATAM, CTD, ICH, MA.


[Full Text Article]

Call for Paper

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More

Online Submission

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More

Email & SMS Alert

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More