During the training session, it became clear that the EMA had made decisions about the XEVMPD database (the new EVMPD database) that have not been formally announced to the industry. In particular, the EMA intends to migrate much of the data in the old EVMPD database. This means that, for example, substances used in clinical trials or products approved by the Centralised procedure will be in the database without the Marketing Authorisation Holder (MAH) needing to enter them. They will, however, be incomplete since the new schema has more data elements. For those companies that plan to use the EV Web tool to enter their data, it now means they have less data to add, potentially. However, those companies that have been building their own tool will have to take into account not only the data they need to collect but also what data might already be in the XEVMPD database.
Furthermore, data must only be entered once, and everyone else must reference the entry that already exists. For common excipients, which large numbers of companies will be using, whether you need to create that entry will depend on whether someone has already done it. It means you can’t build your message without constantly looking at the EVWEB system, and right until your entry is processed the actions of another company could potentially produce an error within your system. The problem is minor if your entry is exactly the same as the original, since the system will identify it as a duplicate, but if the description of the new entry varies by just one character, this new entry will be created alongside the original and will have to be manually updated and nullified. But the problems don’t stop there because someone might select the incorrect copy. Given the large number of potential users for the system there is a huge scope for cascading issues.
The incremental nature of the database is somewhat troubling. Going forward, when companies begin entering novel data, the issues becomes less opaque, but at the start it won’t be clear what data needs to be entered until you have verified what data is, or isn’t, in the database. Unless the EMA makes an interface available to allow industry systems to look up, in real time, those records that already exist in the XEVMPD database and their associated EVCODES – the codes that are assigned to each MAH -- it is difficult to see how it would be technically feasible for industry to do much of the initial data take-on for the XEVMPD system other than via the EVWEB tool.
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