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Individual stakeholders generally putting into question the quality of dossiers are rather counterproductive in this joint learning process.
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First limited experiences are available from the dossier evaluation in 2011/2012, but it seems too early and not really helpful to make general statements on the quality of registration dossiers already at the present stage.
Although we, and also ECHA [2] are not completely satisfied with the quality of many dossiers and the way the information requirements were interpreted, we'd like to congratulate the world-wide chemical industry for managing this challenge in time.
If that is the case, many orphan drugs will not reach the market because the sponsor will not be able to show evidence of favourable characteristics of the product due to the poor quality of the dossier.
Registrants are requested to take over their responsibility for compliance and quality of the registration dossiers and the assessments.
The focus of industry may shift to improving the quality of the registration dossiers and SDS when these more time-consuming processes are completed.
To assure a safe use of chemicals, manufacturers, importers and downstream users need to take over the responsibility for compliance and quality of the registration dossiers and the assessments including risk management.
In an interview, Mr. Gharani's lawyer, Clive Stafford Smith, called the quality of the information in the dossier "drivel".
The first six years experience of mandatory fourth hurdle (i.e. local cost-effectiveness evidence) for new pharmaceuticals indicated that the quality of economic evaluations submitted in pharmaceutical reimbursement dossiers and the quality of critical appraisal by the HTA Office varied considerably.
Feedback to the companies would be useful not only for subsequent additional demands but also on dossiers or parts of dossiers that were examined and accepted.
There is a whole range of dossiers on which we have even regressed somewhat.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com