Literature DB >> 30428898

The Swedish Medical Products Agency's rules of procedure.

Catarina Andersson Forsman1.   

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Year:  2018        PMID: 30428898      PMCID: PMC6237002          DOI: 10.1186/s12961-018-0372-3

Source DB:  PubMed          Journal:  Health Res Policy Syst        ISSN: 1478-4505


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The Swedish Medical Products Agency (MPA) is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and marketing of medicinal products. Relenza, a neuraminidase inhibitor used in the treatment of influenza, has been evaluated by both the Swedish MPA and the United States Food and Drug Administration. In a paper by Mulinari et al. [1], the divergent conclusions reached by the authorities are discussed. The purpose of this letter is not to discuss the conclusions drawn by Mulinari et al. [1], but to comment on the way they refer to an assessor at the MPA. By naming a specific assessor at the MPA, the reader is given the false impression that a single employee is solely responsible for the benefit–risk evaluation of a drug. We want to emphasize that all assessments at the MPA are the work of a team of assessors with complementary competencies, including a comprehensive standardized quality assessment procedure for each decision. Hence, it is the MPA, as a national regulatory agency, that is responsible for any opinion or decision. Besides giving a misleading description of regulatory procedures, the publication of an individual assessor’s name adds no scientific value to the paper and could therefore have been omitted.
  1 in total

1.  Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of 'deep' product reviews.

Authors:  Shai Mulinari; Courtney Davis
Journal:  Health Res Policy Syst       Date:  2017-11-09
  1 in total

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