More work needed for EU RMP initiative to be fully beneficial, says generics industry
This article was originally published in SRA
The EU generics industry says that while a new initiative that aims to help drug makers in the EU, especially generics companies, prepare risk management plans is a step in the "right direction", "further steps" are needed to ensure that the initiative is fully beneficial for the sector1-3.
You may also be interested in...
From looking at ways to reduce the number of audits undertaken by companies to fulfil their pharmacovigilance obligations to calling for harmonized assessment of risk management plans, the EU generics and biosimilars industry group Medicines for Europe says it is ready to explore some radical proposals to simplify the current pharmacovigilance requirements.
After agreeing on an EU-wide harmonized approach to deal with nitrosamine contamination in medicines, a newly-created regulatory oversight group has identified several topics requiring further scientific discussion.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.