New ICH Guideline Could Hold The Key To Better Global Management Of Product Variations
Executive Summary
The growing complexity of procedures for making post-approval changes to product dossiers at global level is proving problematic for regulators and companies alike. Andrew Deavin, director of global regulatory affairs at GSK Vaccines, spoke to the Pink Sheet’s Ian Schofield about ongoing efforts to achieve greater regulatory convergence in life cycle management processes, including a new ICH guideline that could prove a “paradigm shift” in the handling of variations.
You may also be interested in...
African Regulatory Harmonization Project Cuts Drug Approval Times And Saves Scarce Resources
A pilot project of joint assessments in East Africa has shown that regulatory review times for a number of branded medicines were reduced from one or two years to a median of seven months, representing a reduction of 40-60%. The project was part of the African Medicines Regulatory Harmonization initiative, which is intended to strengthen and align regulatory practices in sub-Saharan Africa. Part one of this article looks at the history of the AMRH, the 2016 Model Law that guides national regulators in implementing their own procedures, and the East African pilot that has shown joint reviews to be feasible at the regional level.
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.