News dal mondo
USP's Generics Access Plan to Aid FDA Efforts
USP last week unveiled a new Generic Access Plan as part of its collaboration with the US Food and Drug Administration (FDA) to better facilitate generic drug competition...[RAPS]
Swissmedic Started to Enter GMP Compliance Information into EudraGMDP
The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance...
EU Takes Another Step Towards Adopting SPC Waiver Proposal
The European Union's proposal to allow manufacturing waivers to supplementary protection certificates (SPC) is one step closer to adoption after...
European manufacturing waiver to ‘level the playing field’
Pharmaceuticals: Commisssion welcomes agreement on proposal to facilitate EU exports
The Commission welcomes the political agreement...
US FDA CDER Proposes Program to Create Voluntary Pharmaceutical Quality Standards
With an aim to promote innovation in pharmaceutical development and manufacturing, the US Food and Drug Administration's (FDA) Center for Drug...