Industry depends on regulation: report

Europe’s pharmaceutical industry is finding its problems are being “exacerbated” by legislative regulation, a report has concluded.

Analytical firm Frost & Sullivan point to “regulatory challenges” costing firms “time and money” centred around requirements for drug labelling during clinical testing and delays in acquiring governmental approval for the products produced.

But the report emphasised that legislation aimed at “harmonising” the industry through streamlining was beneficial to the pharmaceutical development process, with old conflicting sources of regulation being replaced by new EU-wide guidelines.

“Fundamental drivers that will improve and strengthen the evolution of the drug discovery process in western and eastern Europe are yet more strict regulations, mandatory good manufacturing practice (GMP) compliance and improved legislations for clinical trials to create opportunities for an efficient competitive environment,” said Dr Amarpreet Dhiman, a research analyst at Frost & Sullivan.

Frost & Sullivan predicts that improvements in regulations are likely to “fast-track” approvals, enhance data protection and enshrine the rights of small and medium enterprises by 2012.

Existing problems, including cost pressures, shorter product life-cycles and clinical trial issues, are likely to diminish as further regulation irons out inconsistencies, giving the industry an optimistic future, the report concluded.

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