Clinical and Non-Clinical Safety Updated Data Management for Medicinal and Biological Products

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Authors : Dinesh B.


A Periodic Safety Update Report (PSUR) is intended to provide an update of the worldwide safety experience of a VMP to Competent Authorities at defined time points post-authorisation. At these times, MAHs are expected to provide succinct summary information on all adverse events together with a critical evaluation of the benefit-risk balance of the VMP in the light of any new or changing pharmacovigilance information. This evaluation is necessary to ascertain whether further investigations need to be carried out and/or whether changes should be made to the SPC or other product information. For VMPs:

  • purely nationally authorized;
  • authorized within the scope of Directive 87/22/EEC (ex-concentration procedure);
  • that have benefited from the MRP or the DCP in accordance with Directive 2001/82/EC;
  • that have been subject to referrals considered under Articles 36, 37 and 38 of Directive 2001/82 

PSURs should be submitted to DGV in accordance with point 2 of Article 110.º of Decreto-Lei n.º 148/2008, from 29th July, as amended by Decreto-Lei n.º 314/2009, from 28th October. The requirement for the submission of a PSUR applies irrespective of whether the VMP is marketed or not.

Any failure of a key PSUR process will have the opposite effect - a poor quality report that will give little insight into emerging safety signals or provide misleading information that can adversely affect public health. A pragmatic approach that will avoid or minimise these pitfalls includes the following: adequate resource planning, training, development of 'scripts' designed to maximize the capture of key information for medically important reactions, standardized and harmonized Medical Dictionary for Regulatory Activities (MedDRA) coding procedures, pre-specified search criteria for data retrieval, ongoing medical review, and metrics to evaluate the effectiveness and efficiencies of these processes. With these quality measures in place, the utility of the PSUR as an effective pharmacovigilance tool is enhanced


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