Requirements for industry now available on submission of clinical data for publication03/03/2016The European Medicines Agency [EMA] has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data.
EMA’s pioneering policy entered into force on 1 January 2015 and applies to clinical reports contained in all marketing-authorisation applications submitted on or after this date. The first reports are currently foreseen to be publicly available in September 2016.
"With this guidance, the Agency is moving towards the operational implementation of its proactive publication policy, which launched a new era of transparency," says Noël Wathion, EMA’s Deputy Executive Director. "The guidance will ensure that companies are aware of what is expected of them and are ready for the publication of these critical data"…
Well it may not look like much, but it’s huge. It means that the EMA’s program to release the raw data from clinical trials is on track for September. Nothing could be much bigger in my book. I haven’t reviewed the guidance to see how much damage industry’s negotiation about redactions has done, but that’s for another day. Right now, I’m just going to enjoy the fact that the forces of good prevailed and they’re on track and moving ahead…
What is simply amazing is that the EMA’s efforts over the past few years are simply unknown here. You might expect that from most people since clinical pharmacology is not their central concern,but at the last meeting of the American College of Neuropsychopharmacology (ACNP) essentially none of my colleagues knew or cared. Perhaps their basic feeling is , it won’t happen here.
When I queried the top FDA officer in this area as to whether the FDA was preparing to study the issue ,I was told flatly that the EMA efforts were illegal. He is probably right. The USA is embedded in a ultra-complex, federal and state , legal structure for the protection of “trade secrets”. Case directly in point, the USA’sl advanced FDAAA legislation establishing the mandatory registry clintrials.gov has been effectively ignored by industry. The clear , but disheartening , articles by its administration have been published in first rate journals ,with no public or congressional reverberations. If the EMA succeeds–remember the blockade lawsuits–it may be such an embarrassing contrast that it gets noticed. But there is no central authority with the independence and authority of the EMA in the USA.. Sorry to be a wet blanket.