Indications from the EMA in their communications with industry associations are that the EVMPD guidances are just around the corner, with suggestions that they could be available by mid-January. To be honest, I remain somewhat unconvinced as to whether this will happen as promised, since deadlines have come and gone in the past. And as we’re already into mid-January, my skepticism appears to be bearing out.
Nevertheless, there are firm indications that pressure from the trade associations on behalf of industry has resulted in some realisation by the EMA that they are asking too much in the short timeframe. That’s not to say there will be a stay on the mandate. That absolutely won’t happen. But there could and likely will be some form of leniency on areas such as structured substance information. What that will be, though, remains a mystery to all but the agency.
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