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Results of IFAH Survey on readiness of Industry for e-Submissions

Results of IFAH Survey on readiness of Industry for e-Submissions. 7 May 2009. Slide 1-IFAH Survey. Response rate: 50% (8 companies contacted) 100% intend to do e-submission for CP, DCP/MRP from end of 2009 (Half of respondents were happy to submit e-dossiers only) National submission: 25%

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Results of IFAH Survey on readiness of Industry for e-Submissions

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  1. Results of IFAH Survey on readiness of Industry for e-Submissions 7 May 2009

  2. Slide 1-IFAH Survey Response rate: 50% (8 companies contacted) 100% intend to do e-submission for CP, DCP/MRP from end of 2009 (Half of respondents were happy to submit e-dossiers only) National submission: 25% Possible reasons for this low take up are: • Industry is not sufficiently informed of this possibility • National agencies are not ready yet to accept them, e.g. some companies submitted electronic PSURs for national procedures and for the harmonised birthdate project: 12 countries rejected it and required paper.

  3. Slide 2-IFAH Survey Potential obstacles identified : Regulatory requirements: • National non-harmonised requirements (language, specific documentations, and signature), thus commitment of all NCAs to support and apply an EU GL is important. • Remaining paper requirements on long term: complexity and cost of the management of two submission systems. But still need transition phase, also for industry

  4. Slide 3-IFAH Survey Potential obstacles identified : Technical requirements: • With simple specifications (as current EU GL): technical hurdles should be low. Impact internal organisation in companies (all departments): changes of process, procedures to be updated, quality assurance of the file. • Non compatibility among EU and national systems. • Handling multiple electronic formats e.g. according to current EU GL, a potential eNTA format and other regional or national formats outside EU (e.g. FDA).

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