EU launches landmark decentralized generic drug approval pilot program
- The International General Drug Regulators Pilot Program (IGDRP) was launched in 2012. Its goal is to establish a collaborative relationship between various countries’ regulatory agencies.
- The first pilot will last for three years and include Australia, Canada, Chinese Taipei, and Switzerland.
- The EU is exploring other collaborative possibilities beyond just the decentralized approval process, including inspections of sites at which bioequivalence and bio-analytical studies are conducted.
The overarching goal of the IGDRP is to make the scientific assessment process for generic medications simpler and stronger, while sharing vital information and leveraging existing synergies. As it stands now, if a generic drug is approved in any of the four participating countries, it is automatically granted approval in the other three countries.
While there are just four participating countries during phase one of this initiative, other nations will have the option to join later on. These countries include Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore, and South Africa.
- Pharmaceutical Business Review EU begins pilot on decentralized generic drug application clearance