The Head of Medicinal Agencies (HMA) eSubmission Roadmap (November 2014) already highlighted that from 2016 all new veterinary Marketing Authorisation Application’s (MAA’s) for the Decentralised and Centralised Procedure (DCP and CP respectively) have to be in VNeeS format. Furthermore, from 2017 all veterinary submissions via the EU procedures need to be compliant with VNeeS. The recently released guideline prepared by the Veterinary Harmonisation Group (March 2015) provides some more details with regards to formats, file folder structure and naming conventions, coming into effect October 2015 already.
This highlights a number of challenges for the pharmaceutical industry providing veterinary medicines. Read More
By Dr Olaf Schoepke, Director of Strategic Development, Samarind RMS
Last time I blogged here, we spoke about how important drug information can get spread around multiple systems. We believe that clients are finding this more and more an inefficient way to work, which is why we are starting to recommend that instead they move to ‘flip’ data – keeping it on one system that can then be the source for when it needs to be driven to where it needs to be at the right time in the whole massive research-trials-approval-pharmacovigilance-reporting process.
If you want to know why, think about those big systems, the five or six trails or submissions structures which you are probably currently working with. So, when you think about these silos, for example, if you have to use four or five silos for four or five systems, how do you combine these? At the moment, you take one system and you integrate it with the others. Say you currently have a kind of base, a foundation, which is fine: now you can link system 1 to system 2 and then system 2 to system 3 and back to system 1 and so on.
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.
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.