Guidance

Pharmaceutical manufacturing and production sector: Focus on Enforcement regulatory review

Findings from the review of regulatory enforcement in the pharmaceutical sector.

Documents

Focus on Enforcement regulatory reviews: Review of the pharmaceutical manufacturing and production sector

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Details

The Focus on Enforcement project asks the public to help identify where regulation can be improved, reduced or done differently.

This report summarises the findings of the Focus on Enforcement review of enforcement as it affects the pharmaceutical manufacturing and production sector. It covers:

  • compliance and enforcement activity
  • advice available to business on how to comply with the law
  • overlaps, gaps and coordination between different regulators
  • inspections of locations and equipment by regulators
  • perceptions of the law that may drive unnecessary behaviour
  • responding to unfair or unnecessary requirements inposed by regulators
  • enforcement proceedings taken by regulators
  • whether there is unreasonable or unnecessary pressure brought to bear on providers by third-parties
Published 12 June 2014