Month: July 2018

Brexit, EMA

Can the UK stay in the EMA post-Brexit?

On July 17, 2018, the UK Parliament voted to remain in the European Medicines Agency (EMA) after Britain withdraws from the European Union (“Brexit”). This is not a done deal: the vote only means that the UK government must negotiate to continue to participate in the EMA. This will probably involve negotiating an appropriate payment …

ARIM, EMA, IDMP

And if IDMP never happens?

Well, for one, it will. European Parliament has legislated that it must.  But it could come in many different forms, perhaps with nothing more than the minimal data to determine a Medicinal Product ID that gets used on an Adverse Event Report. That means the following items are the barest minimum of data that must be …

ACUTA, ARIM, ARIM Publisher, eCTD, FDA, Uncategorized, Validator

FDA Validation Criteria to change July 27

On June 21, FDA announced changes to their eCTD validation criteria, to be implemented on July 27. The first is to remove a low-severity item, #5025, which would highlight the lack of PDF-fillable forms. The rest are a set of new validation rules, numbered 1-7, that were previously part of their Submission Acceptance criteria — …

ACUTA, ARID, EMA, FDA, Health Canada, Software Release

ACUTA Regulatory Intelligent Documents (ARID) v1.1 Released

I’m pleased to announce that ACUTA has released version 1.1 of the ACUTA Regulatory Intelligent Documents, or ARID for short. ARID is a set of over 325 shell documents (up nearly 50 from the previous version) and a carefully curated set of Word tools combined with the most-used features from the ribbon, on a single …