Latest From Ian Schofield
EU Adopts New Rules On UK-Wide Approvals For Novel Drugs
Having been passed by the European Parliament and now the Council of the EU, new legislation will clear up some of the issues raised by Brexit relating to trade in medicines between Great Britain and Northern Ireland.
UK In Major Move To Boost Commercial Clinical Trials & Improve Life Sciences Environment
The publication of two major reports has led the UK government to announce a £650m “Life Sci for Growth” package to bolster the life sciences sector.
UK Reveals Seven Partners Whose New Drug Approvals It Will Recognize
The UK regulator, the MHRA, says that while it will recognize drug approvals granted in the EU and a selection of other countries, it will remain a “sovereign regulator” with the ability to reject applications if they don’t meet its standards.
EU Pharma Revision: Legislators Prepare For Long-Haul Debate
The European Parliament and the Council of the EU are preparing their positions on the planned overhaul of the EU medicines legislation ahead of discussions that are expected to take two to three years.
EU Drug Approvals Could Be Denied If Environmental Risks Not Properly Assessed
As part of its revision of the EU medicines legislation, the European Commission is proposing tighter rules to reduce the environmental impact of medicines. Companies may want to start thinking now about whether their current environmental risk assessment processes would meet the likely new requirements.
Australian Regulator Warns Of Delays To GMP Clearance Processes
Drug sponsors have been told to continue applying for extensions to good manufacturing practice clearances for overseas manufacturing sites as long as they meet the criteria for extension and apply in good time.