Proposed Harmonized Requirements for Licensing of Vaccines in the Americas

(110 KB) Español

(63 KB) English

Guidelines for Preparation of Applications

(108 KB) Español

(91 KB) English

(96 KB) Français

A Vaccines Working Group of the Pan-American Network on Drug Regulatory Harmonization (PANDRH) was established in March 2005 as a response to the need for developing harmonized documents in this field. At its first meeting, held in Panama in June 2005, the Group composed of National Regulatory Authorities of seven countries (Argentina, Brazil, Canada, Chile, Cuba, Mexico and Venezuela), proposed as its priority the development of harmonized registration requirements for vaccines for human use for the region. Information derived from a survey carried out by the Pan-American Health Organization (PAHO), as Group Secretariat, of licensing requirements for vaccines in 16 countries of the region was reviewed in detail.  A second meeting of the Working Group, held in December 2005 in Venezuela, proceeded to identify and agree upon the basic requirements and data which need to be submitted by a manufacturer to a National Regulatory Authority in support of an application for licensing.  At the Group’s third meeting, held in Canada, the first draft of a document on harmonized requirements for the licensing of vaccines in the region was reviewed and developed further, as was an accompanying guideline on the preparation of applications.

The two draft documents are: Proposed Harmonized Requirements for Licensing of Vaccines in the Americas, and an accompanying attachment entitled Guidelines for Preparation of Applications. They are available in the original Spanish, as well as in English and French translations.  The information required is structured using the International Conference on Harmonization (ICH) Common Technical Document (CTD), specifically adapted to the market authorization of vaccines, and complemented by Recommendations for vaccines published by the World Health Organization’s Technical Report Series. Because of their special characteristics, vaccines should always be considered as new products for the purpose of market authorization.

The purpose of these documents is to achieve greater harmonization in the information submitted in the application for Market Authorization of vaccines for human use. They apply to all vaccines to be registered, regardless of whether they are manufactured in the country of origin or not. Since the same information should be submitted to all countries in the Americas, the licensing process and ultimately the availability of vaccines should be facilitated. It is expected that having a common document will also benefit the region by making more efficient use of technical and financial resources, as well as facilitating mutual recognition processes where appropriate.

These draft documents are posted on the PAHO as well as the Health Canada websites for the purpose of inviting comments and suggestions on the proposals contained therein.  Comments proposing modifications to the texts MUST be received by May 30, 2008 and should be addressed to:

Dra Maria de los Angeles Cortes
Regional Advisor on Vaccines and Biologicals,
Technology, Health Care, & Research (THR/EV)
Pan American Health Organization
525 23rd St. NW. Washington DC. 20037-2895

  Email: cortesan@paho.org