Transcription of Q & A on PSUSA: Guidance document for assessors
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Q & A on PSUSA: Guidance document for assessors
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 31 October 2017 EMA/518909/2016 Human Medicines Evaluation Division Q & A on PSUSA: Guidance document for assessors Since the start of the Periodic Safety Update Report (PSUR) single assessment (PSUSA), this procedure has posed a certain number of challenges that are specific to the EU single assessment of PSURs of medicinal products approved nationally.
An explanatory note to GVP Module VII for MAH has been developed ... consultation with a Scientific Advisory Group/Ad-hoc expert group. Page 3/13 1.2. Strength of evidence in the context of the stage in the product lifecycle ... not adequately addressed, the LMS can request the MAH to provide the supporting data during the PSUR assessment ...
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