The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines
The European Medicines Agency (EMA) released two guidance documents to
help improve the process of assessing periodic safety update reports (PSURs).
Marketing authorization holders submit PSURs, which evaluate the benefits and
risks of a medication, to the agency after authorization. EMA uses the reports
to assess the benefit-to-risk balance of the medication to determine the
continued safety of the drug. Products that contain the same API or combination
of APIs are assessed jointly in a single assessment procedure.
The assessment process was streamlined to “ensure that all the evidence
generated about medicines containing the same active substance is
reviewed at the same time by one authority, resulting in consistent safety
information,” EMA stated in a press release. Explanatory Note to GVP Module VII addresses
concerns that companies have expressed during the two years since the PSUR
single assessment process started in 2015. The guidance discusses several
topics, such as the scope of information to be included in PSURs, changes to
therapeutic indications, information for generic drugs, reference product
information, safety actions taken by countries, patient exposure, and signal
evaluation.
Assessors' Questions and Answers (Q&A) Guidance on PSUR Single
Assessment (PSUSA) gives assessors guidance on the
evaluation process of PSURs. The agency is planning joint training in 2017 for
both industry and European Union authorities on the implementation of the
single assessment process.
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