Abstracto

Helping each other regulate clinical trials: a network of vaccine regulators from developing countries

Sergio A Nishioka, James Southern, Rolando Dominguez, Nora Dellepiane

In the early 2000s the WHO acknowledged the growing importance of national regulatory authorities from emerging countries to face the challenge of new production technologies and the emergence of vaccine manufacturers from these same regions. The establishment of the Developing Country Vaccine Regulators’ Network (DCVRN) was part of the WHO’s strategy of strengthening national regulatory authorities in vaccine-producing countries and promoting their collaboration through networking. The interaction among the DCVRN members during the network’s 8 years of existence has facilitated the development of these regulatory authorities in areas such as good clinical practice inspections and reporting of adverse events during clinical trials, and the proposal of an investigational new drug-like system for developing countries. The DCVRN has interacted, among others, with regulators and with vaccine manufacturers, and has had technical/scientific discussions on most novel candidate vaccines of interest to developing countries and also on old vaccines produced by new manufacturers. Recent administrative changes at the WHO, which have put vaccines and medicines under the same umbrella, offer challenges but also opportunities for the future of the DCVRN.