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Transparency EMA

Starting this autumn, the EMA will ask CPs Applicants to send clinical information from your registration dossier eCTD format. These new requirements are part of the Transparency Policy (Policy/0070).

Starting this autumn, the EMA will ask CPs Applicants to send clinical information from your registration dossier eCTD format. These new requirements are part of the Transparency Policy (Policy/0070).
September 23, 2015

Here you can find a summary of the EMA requirements and new services we
have to consider implementing. For CPs submitted after 1 january 2015, the
clinical information of the dossier has to be submitted:

  • Between
    day 181 and 220 of the calendar by EMA gateway.
  •  2 eCTD sequences
    must be submitted

              1. Redaction
    proposal: proposal of redacted confidential information
              2. Final
    redaction: after revision by EMA, agreement on final texts that are going to be made publicly available must be submitted, together with a cover letter.

  • Clinical
    information involved:

       1. Clinical summaries
       2. Clinical overview
       3. Clinical study reports of module 5 plus 16.1.1,
    16.1.2 and 16.1.9

  • Evaluation
    process:

       1. Internal receipt
    / distribution stage – 5 calendar day
       2. Validation
    stage – 11 days
       3. Validation
    of justification table + clarification if needed Assessment of CCI stage – 31
    days
       4. Request for
    additional info via eudralink if needed, followed by agency final conclusion

If you have
any questions or need more information please contact us through this email:
info@asphalion.com

More info
from EMA: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000526.jsp&mid=WC0b01ac0580789730

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