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Updated QRD templates released

Updated QRD templates released
Sure, the Quality Review of Documents (QRD) templates may be imperfect - but they are getting better.

Case in point: Over the past few months, we have seen a couple of updates to the templates. At the end of August, the templates relating to mutual-recognition, decentralised and referral procedures were updated. A few days ago, further updates to all templates in all 24 languages were published.

Head on over to the EMA web site for the latest information and templates.

[Hat tip to Catherine Guilliaumet and Renate Cisne]

For more on this topic, take a look at the following:
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  1. cgtradmed said...
    Thank you for this alert. I hope that, this time, it will be for good. My "EMA"file looks more and more like a pregnant woman tired of carrying without knowing when it will come to term.
    cgtradmed said...
    Hi! I'd like to draw your attention on a strange point :
    Though EMA has updated the English version on Oct 12th, the French on-line versions have not been modified, whatever is the type of procedure concerned.

    For instance, in the "Quality Review of Documents human product-information template version 8 - highlighted", in the EN version (Rev. Oct 12) you can read this :

    <2.1 General description> [For advanced therapy product only]

    <2.2 Qualitative and quantitative composition> [For advanced therapy product only]"

    But, the French version - still dated 07/2011 - still reads :

    <2.1 Description générale>

    <2.2 Composition qualitative et quantitative>"

    As you can see, there is neither modification nor addition.

    Do you notice the same thing for other languages ?


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