PAHO/WHO initiative: Proposed harmonized requirements for the licensing of vaccines in the Americas
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: Maria de los Angeles Cortes, Regional Advisor on Vaccines and Biologicals, Technology, Health Care, & Research (THR/EV), Pan American Health Organization PAHO/WHO Washington DC. Email: firstname.lastname@example.org