Ian Schofield
Executive Editor
Latest From Ian Schofield
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.
Denmark Planning To Impose Drug Stockpiling Obligations From July
A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.
National Drug Stockpiles Create ‘False Sense Of Security’
The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.
UK Explains New Rules On Parallel Imports From EU
Guidance from the Medicines and Healthcare products Regulatory Agency says that the packaging of parallel imported medicines must make clear that they are for the UK market only.
UK Industry Gets More Time To Adapt To Post-Brexit Import Rules
The BioIndustry Association has welcomed a decision to delay the deadline for compliance with new regulations on the classification of imported materials used in drug production, but says the border rules are still not proportionate for life science products.
Industry Calls On G20 To Boost Regulatory Harmonization & Tackle AMR
Robust regulatory systems with effective approval pathways and surveillance mechanisms to ensure continuity in clinical research, manufacturing and supply are needed to prepare for current and future health threats, says industry.