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‘Give Us More On Warning On Publishing Our Clinical Data,’ Industry Implores EMA

 
• By Neena Brizmohun

Drug companies are worried that the European Medicines Agency is not giving them enough advance notice on when it will contact them to submit their redacted clinical reports under Europe’s landmark transparency policy on proactively publishing clinical data. The EMA, meanwhile, says it is considering a possible solution, that it is taking care to nurture companies that are going through the submission process, and that it is not too bothered about industry missing deadlines.

The European Medicines Agency is still determining whether or not it can meet a request from drug companies for more warning on when they will be asked to start redacting their clinical reports for publication under the agency’s policy on proactively publishing clinical data.

Industry says that since the policy came into effect in 2015, it has been difficult for individual companies to estimate...

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