Following the publication of the latest EMA guidance – which was updated again on 5th March – my previous blogs examined the five new fields that are required by the EMA and the XEVMPD data quality and controlled vocabularies. Here in the final blog of this set I’m covering local language SmPCs and timelines, and offering my opinion on the situation and how best to achieve compliance.
Following the publication of the latest EMA guidance, my previous blog examined the five new XEVMPD fields that are required by the EMA. This time I’ll cover how to improve the quality of your data and the impact of the tidying up the controlled vocabularies. Local language SmPCs and timelines will be in the final blog of the series.
Most of you will have seen the latest EMA guidance by now (all 484 pages of it) – and read the much more digestible 4-page article by Andrew Marr in Scrip. Andrew’s article is an excellent summary of what’s required, and I thought it might be useful to reflect on the points he raises and translate his ‘what you need to do’ into a ‘how to do it’.
I’ve divided the points up into a discussion about the new fields, how to improve the quality of your data, the impact of the tidying up the controlled vocabularies, local language SmPCs (summaries of product characteristics) and timelines. I’ll talk about the new fields this time, and the rest in the next couple of blogs.