Life sciences technology vendors and consultancies are busy promoting Identification of Medicinal Products (IDMP) compliance solutions, which seems odd given that many details of the final requirements have yet to be published. With a further two years to go until the latest deadline comes around, organisations have every reason to be sceptical of the value of investing now, says Marc Chaillou of Schlafender Hase.
It has been a source of consternation that the European Medicines Agency (EMA) keeps pushing back the deadline for ISO IDMP (Identification of Medicinal Products) compliance. The latest timescales give companies two more years to get their data in order before the authorities formally clamp down and expect full adherence. It does serve everyone’s interests that such a definitive international standard for product data exchange is effective and supports the high quality and reliability that will ensure the data’s value. However, the proposed phasing of adoption and now further delays to publication of the fuller requirements as well as the cut-off for compliance are sapping any remaining momentum around the initiative and prompting life sciences companies to prioritise spending elsewhere.
This has not stopped the life sciences technology and services industry from promoting IDMP software and solutions however, which seems odd given that the finer details of the medicinal dictionary definitions have yet to be set in stone. It would seem that vendors and consultancies are approaching the challenge/opportunity the wrong way round – offering to get manufacturers’ databases and submissions systems up to spec even before that spec has been confirmed. Seeing that solutions are available on the market could lull companies into a false sense of security, and worse, encourage them to invest inappropriately – i.e. in the wrong order.
That is not to say that they shouldn’t be preparing. On the contrary, life sciences organisations have their work cut out with IDMP. It is such an ambitious project, on such an ambitious scale, that it will take a lot of time to align all the right pieces. And unless companies can deliver the quality and reliability EMA and ISO have in mind, they will compromise not only the payback on their own outlay, but also the intended benefit to patients. After all, it is their safety that IDMP is designed to ensure - by making the target database a robust, definitive, harmonised record of approved and marketed drugs using agreed definitions and terminology.
As such, IDMP will be central to mass-scale, cross-border pharmacovigilance. Its slowness to get off the ground is down to the ISO’s ambitions for the set of standards, which are much grander and more comprehensive than previous attempts at electronic publishing requirements (most recently XEVMPD), under the remit of Regulatory Affairs. The implications of this are that data preparation will now touch all corners of the organisation, as well as outlying parties including in-country affiliates and supply-chain partners. All have a part to play in ensuring that core systems and applications contain the latest, accurate information. Consistency and reliability are paramount.
This article is taken from Vol.9, Issue 3 Journal for Clinical Studies