FDA-EMA Pilot Advice Scheme On Complex Generics Sees Slow Uptake
Two Applicants Have Completed The US-EU Parallel Advice Process So Far
While approaching the third year of its launch, the parallel advice program has seen a handful of applicants, but regulators on both sides of the Atlantic remain optimistic.
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A proposed joint framework for complex generic development between the US and EU could reduce study duplications by eliminating the need to use locally approved comparators, a move that has been embraced by other regions and international organizations.
The IGBA has kicked off its third annual global biosimilars week awareness campaign with the release of a white paper that urges stakeholders to recognize and adopt recommendations from the WHO’s latest revised biosimilars guideline.
The US FDA and EMA have announced a pilot program to provide parallel scientific advice on complex generics and hybrid medicines for prospective applicants, with a goal of harmonization and increased regulatory convergence.