Who regulatory collaboration

The International Generic Drug Regulators Pilot (IGDRP) was launched in 2012 as an international collaborative initiative for information- and work-sharing activities for the regulation and registration of generic drug products.

The European regulatory system for medicines

Manufacturers, importers and distributors of medicines in the EU must be licensed before they can carry out those activities. The regulatory authorities of each Member State are responsible for granting licences for such activities taking place within their respective territories.