EMA updates procedural advices for users of the Centralized Procedure

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EMA has released an update of the following procedural advice documents for users of the EU Centralized Procedure (Human Medicines):

As a common update to all three procedural advice new requirements were introduced with respect to information required in an marketing authorisation application dossier regarding GCP inspections and GLP compliance. A corresponding chapter has been newly introduced in the respective procedural advice documents. The following information must be provided as annexes to the Cover Letter:


Regarding GCP Inspections:

  • A list of GCP inspection(s) conducted or planned by any regulatory authority at clinical trial sites for all clinical trials included in the dossier. In case of BE trials a list of the inspections conducted at the clinical and analytical facility where the study was conducted. Alternatively, a confirmation that no inspections had been requested nor taken place and that no inspection are planned.

Regarding GLP Compliance:

  • A summary table, listing the non-clinical studies and indicating for each study:
    • study title,
    • study code (Unique identifier assigned to the study),
    • date of completion of the Final Report ,
    • test facility and test sites in which the study was conducted,
    • complete address of the test facility (and test sites where applicable),
    • period in which the test facility(ies) and/or test site(s) was(were) used indicating if in that period they were part of an European Union (EU) or an Organisation for Economic Co-operation and Development (OECD) Mutual Acceptance of Data (MAD) accepted GLP monitoring programme.
  • Regarding GLP compliance, as per Notice to Applicant, Volume 2B, there should be a comment in Module 2.4 Nonclinical Overview and Module 2.6 Nonclinical Summary on the GLP status of the studies submitted in the application.

(Quotation end)

An additional update has been included in the procedural advice for generic / hyprid products. This additional update deals with an update of the Product Information required as a result from a single PSUR procedure. Instead of providing the answer here a reference has been included to the general Post-Authorisation procedural advice from EMA.

[Source: EMA]

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