Immunization standards

Regulatory Pathways

Addressing new challenges: development of innovative regulatory pathways for novel vaccines

Until recently, most of the National Regulatory Authority (NRA) strengthening activities focused on the ability of NRAs to exercise a regulatory oversight on vaccines that were licensed and used in developed countries. Many new vaccines, however, are now being developed for use in the developing world and sometimes exclusively in these markets. More clinical trials are being conducted in countries with weak regulatory systems, who are therefore confronted with new challenges which they are not in a position to address.

The NRAs of these countries need to rapidly be able to:

  • establish regulatory strategies to regulate clinical trials taking place in their countries
  • perform a regulatory review of clinical trial applications
  • assess clinical data and product characteristics to respond to license application.

The timeframe required for the implementation of the above systematic strengthening activities is however longer than the actual timeframe imposed by the advanced development of new vaccines.

Therefore, the regulatory pathways initiative aims at addressing the challenges faced by developing countries that are target for clinical trials or introduction of new vaccines.
The objectives are:

  • the support for the preparation and implementation of regulatory strategies for the assessment of clinical trial applications
  • the establishment of regulatory mechanisms for the licensing of new vaccines not registered in the country of manufacture.

The main activities include:

  • the establishment of regulatory mechanisms for the licensing of new vaccines not registered in the country of manufacture.
  • establishment and secretariat role to the Developing Countries' Vaccine Regulators Network (DCVRN)
    • to exchange experience on the evaluation and regulatory review of new vaccines.
  • collaborating with the European Medicines Agency, with regards to the procedure of EMEA's scientific opinion issued for vaccines manufactured in Europe for exclusive use in developing countries.
  • collaborating with US Food and Drug Administration (FDA) and other NRAs in developed countries to develop new regulatory strategies to facilitate licensing of novel vaccines.
  • Facilitating the establishment of regional networks of regulatory authorities and research centres to address the short term need for review of clinical protocols, monitoring trials and evaluation of trial data
    • to discuss the specific regulatory needs for the authorization of clinical trials of vaccines in development, develop guidelines for the review of clinical trial applications, and define training needs.
  • Supporting NRAs which have not yet fully developed the expertise for the review of license applications through workshops and technical assistance.

Global Initiatives

Regional initiatives

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Last update:

10 November 2011 21:00 CET