By: Andrea Castillo, Olga Torres.
On June 7, 2022, the Department of Regulation and Control of Pharmaceutical and Related Products published on its web page the Transitional List of Regulatory Authorities According to the World Health Organization (tWLA), in order to complement the Technical Standard 77-2022 version 5, which refers to the Approval of the Sanitary Registration of Medicines and Vaccines in Guatemala.
Said Technical Standard defines Sanitary Registration Approval as the Official Recognition of the Sanitary Registration granted by Regulatory Authorities qualified by the World Health Organization as Regulatory Authorities of High Maturity and Performance.
The list arises from the World Health Organization’s initiative to create a new classification called World Health Organization Listed Regulatory Authority (WLA), which seeks to replace the Strict Regulatory Authority (SRA) and Functional National Regulatory Authority (functional NRA) classifications.
Based on the above, Authorities with at least a maturity level 3 (ML3) are eligible to be considered as a World Health Organization (WLA) listed Regulatory Authority and must satisfactorily complete the evaluation process; pending approval, they will be included in the Transitional List of Regulatory Authorities According to the World Health Organization (tWLA).
The Transitional List of Regulatory Authorities According to the World Health Organization (tWLA) is in alphabetical order by country, indicating the respective Regulatory Authority, the origin of the transition (classification of the authority) and the scope (drugs/vaccines).
The document is updated through March 31, 2022, based on information published by the World Health Organization at https://www.who.int/publications/m/item/list-of-transitional-wlas.”