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EU Conditional Approval Should Be A Drug Development Tool, Not A Rescue Remedy

 
• By Ian Schofield

Pharmaceutical companies in the EU should see conditional marketing authorization as a useful drug development planning tool, rather than as a "rescue option" to be used when they are unable to secure a full marketing authorization because they have not generated the required additional data, according to a senior European Commission official.

Pharmaceutical companies in the EU should see conditional marketing authorization as a useful drug development planning tool, rather than as a "rescue option" to be used when they are unable to secure a full marketing authorization because they have not generated the required additional data, according to a senior European Commission official.

Speaking at Informa's EU Pharma Law Forum* in Brussels last week, Florian Schmidt of the pharmaceutical unit in the commission's health directorate said that the conditional marketing authorization (CMA) was...

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