Are you on top of all this UDI stuff? And if not – shouldn’t you be? What I mean specifically, is that the USA’s Food and Drug Administration has recently made a ruling that anyone selling medical devices in the US has to add a new ‘unique device identification’ (UDI) to all of its labeling.
Plus – you also have to send details of your devices that regulator’s global unique device identification database The problem is, I suspect that many medical device manufacturers are not fully aware of what this entails, and those that do, have not yet set about creating a good system to meet the requirement.
How familiar are you with the current issues around eCTD, that is Electronic Common Technical Document? (If your primary interest is Europe, see here for more information: http://esubmission.ema.europa.eu/ectd/ and if your interest is in the US, see here)
If you are unsure about the term, which I admit isn’t that user-friendly perhaps, then the good news is it’s not that hard to unpack. All eCTD really means is a standards-based way the industry is going in to move from delivering drug marketing applications to regulatory authorities not in paper, but in an electronic format. The main drivers include a push by the ICH (International Conference on Harmonisation) process – which is to say US, Japan and Europe – which wants to use one common format: hence eCTD. (Please note this is for information on human drugs alone, although there is work going ahead in the veterinary field as well as in cosmetics.)
As we start what looks like another very busy year in the Life Sciences sector, it is important to pay enough attention to an important regulatory issue that will start to play a big role in 2014. I am referring to the issue, of course, of the EVMPD, the European Medicines Agency’s EudraVigilance Medicinal Products Dictionary.
You will recall that every pharmaceutical company that markets products in Europe has to submit the details of those products to the EMA’s database. You may also recall that there were some real challenges for the sector in meeting the original deadline of 2nd July 2012, due to the extremely tight timescales and the ambiguities in what exactly was needed.
Well – here we are again. The EMA guidance on the maintenance of this information is now published, and although we’re still waiting for the data quality guidance to be made available too (due soon) there’s plenty to be working on in the meantime.
As expected, the EMA requires all MA holders to resubmit their product information between June and the end of 2014. And yes, it’s re-submission that’s required, because there are new mandatory fields involved and the quality of the data must be improved. So rather like last time, you have pretty tight timescales in which to gather and submit your medicinal product information.