Canada specifies timelines for inspections in new guidance
This article was originally published in The Gold Sheet
Executive Summary
Health Canada has issued a final guidance outlining its policy on the scheduling of inspections. The guidance is called "GMP Inspection Policy for Canadian Drug Establishments" and requires that new establishments should be ready for an inspection when submitting their application for an establishment license (EL). The agency will perform an initial inspection within three months of receiving a request for an EL. The agency warns that if establishments are not prepared for an initial inspection when contacted by the inspectorate, their application will be withdrawn. The new policy went into effect for all inspections scheduled after Jan. 31. The guidance notes that fabricators, packagers, labelers and testing laboratories will be inspected every 24 months, while importers, distributors and wholesalers will be inspected every 36 months
You may also be interested in...
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.
Investors Go Berserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.