Regulatory Harmonization in Developing Countries Needed to Speed up Neglected Patients’ Access to New Drugs

altNathalie Strub-Wourgaft, Medical Director, DNDi
[October 2012]

The need for regulatory harmonization (i.e. either allowing for centralized drug registration in multiple countries as one single approval, or mutual recognition which entails expediting registration in additional countries once a drug has been registered in a primary country with sufficient regulatory  capacities) in order to reduce the duplication of research efforts, use resources more efficiently, and especially to speed up the process to reach patients, was identified decades ago in Europe.