Immunization standards

Harmonized NRA assessment tool - prototype I version for comments.

Information Note

1. Objective

The World Health Organization (WHO) has developed a revised version of the existing WHO National Regulatory Authority (NRA) assessment tools used for medicines (rev.2007), for vaccines (rev.2011) and for assessments in the Americas Region conducted by the WHO Regional Office for the Americas (PAHO/AMRO) (rev.2012). This new prototype version is the result of a collaborative effort between WHO Headquarters (HQ) and regional offices including PAHO/AMRO, with support from country regulators that have participated in its development either by attending the informal consultation meeting held in Geneva in June 2013 or by pilot testing the tool (Mexico and China). The current version of the harmonized tool is a computerized consolidation of the medicines and vaccines indicators. Regulatory functions as well as indicators/sub indicators that were similar in both tools have been merged and those that were different have been kept separate. The prototype as it stands does not include new indicators. The system can be used by any NRA wishing to pilot test the prototype either by conducting a self-assessment of their regulatory capacity or by requesting that the prototype be used as part of an HQ or regionally planned assessment.
The tool is aimed at facilitating the conduct of a comprehensive assessment for medicines including vaccines or assessments targeted at selected product categories (vaccines or medicines separately). In the future, it is expected that the tool will be revised to address also blood products, medical devices including diagnostics and traditional medicines.

2. Feedback about the use of the tool and its technical content and design

The WHO vaccine and medicine tools including the harmonized tool (prototype 1) are currently posted on the WHO website in excel format (see link below). Comments and contributions by regulatory agencies to the harmonization process, should kindly be sent by email to . The computerized harmonized tool (prototype 1) is also available upon request and is posted on the WHO sharepoint site. Please note that still there are functions and indicators/sub indicators that need to be merged and fine tuned. A working group constituted of regulators worldwide will be established shortly to finalize the harmonization of the existing indicators and to propose a revision of indicators as required. The tool, including the proposed revised indicators, will be discussed for approval at the WHO International Consultation of Experts planned at the end of 2014 in Geneva. Any country or regulatory staff, including staff from WHO regional and country offices, are welcome to provide inputs or comments to : before 1 September 2014. The feedback received will guide the work of the working group responsible for finalizing the tool for discussion at the International Consultation of Experts.

3. Computer and software requirements for the computerized tool

In case of testing the proposed computerized tool the minimum software requirements are :

  • Microsoft Office Professional, version 2010 or higher,
  • Microsoft Access should be included.

The computerized tool should first be downloaded to your computer and then unzipped to be used.

4. Technical support for using the computerized tool

The tool is a prototype 1 version. Requests for technical assistance should be addressed to Please note, however, that we may face some limitations to respond timely to requests for technical assistance regarding the installation or use of the tool.

5. Copyright/Disclaimer

© World Health Organization 2014
All rights reserved.

This health information product is intended for a restricted audience only. It may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means.
The designations employed and the presentation of the material in this health information product do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
The World Health Organization does not warrant that the information contained in this health information product is complete and correct and shall not be liable for any damages incurred as a result of its use.

6. Information on the process followed for the revision of the tool

Please refer to the document entitled "Process for development of a revised National Regulatory Authority assessment tool harmonized across all medicines including vaccines", accessible at the link below.

Last update:

10 October 2014 17:30 CEST