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How to prepare for electronic exchange of ICSRs/SUSARs with the EMA The EudraVigilance system supports the electronic transmission of ICSRs/SUSARs between the EMA and national Competent Authorities, marketing authorisation holders (MAH), applicants and sponsors of clinical trials. Here is an overview of the process and the steps required for the implementation of electronic transmission of pharmacovigilance data. The procedure for notification of initiating electronic transmission of ICSRs is described below. The same procedure should be followed for the electronic transmission of SUSARs by sponsors of clinical trials. Step 1 All parties that have a legal obligation to exchange pharmacovigilance information with the EMA, must register with the EMA to do so. You can find detailed information about the registration process here. Step 2 This is only necessary for Companies/Organisations that choose to transmit using the EV gateway. The EMA is not mandating any particular software for the electronic communication of ICSRs/SUSARs. Your software needs to adhere to the standards as outlined in chapter IV of the "Note for guidance for the Regulatory Electronic Transmission of Individual Case Safety Reports in Pharmacovigilance" Step 3 The successful completion of the communication testing between the EMA and the EDI Partner will be certified by the EMA so that the EDI Partner can move into the subsequent stages of testing.
When a successful connection has been established Safety and Acknowledgement Messages can be successfully transferred between each party in the programme. This is accomplished by sending an encrypted Safety, Acknowledgement or Medicinal Product Report Message to the EudraVigilance Gateway, where it is unencrypted, checked for basic accuracy, then re-encrypted and sent to the ultimate destination. A list of appropriate registered parties will be maintained and distributed by the EMA. Safety, Acknowledgement and Medicinal Product Report Message exchange can only take place between registered parties. This testing is applicable between all EDI Partners and the EMA. It is not required between an Applicant, a MAH or a Sponsor and Competent Authorities other than the EMA, since the EudraVigilance Gateway is the central communication point interlinking all Competent Authorities in the EEA. Step 4 In this step EDI partners carry out development and validation testing with the EudraVigilance test environment at the discretion of the EDI Partner. Once the EDI Partner has completed this test phase they will notify EMA/other potential EDI Partners to move into the XML test phase. This step is applicable for the testing of all EDI Partners with the EMA. Other EDI Partners may decide to follow the same step.Step 5 These XML files are sent to the EudraVigilance test environment with paper reports in parallel to assure the correctness of the XML files and compliance with the requested specifications: syntax, field lengths, minimum information and data coding against ICH E2B (R2) and ICH M1 and M2 standard terminology. This will also allow comparison of the submitted data and ensure quality assurance and data consistency. The successful completion of the testing between the EMA and the EDI Partner will be certified by the EMA so that the EDI Partner can move into production. The currently established regulatory reporting mechanism will remain unaffected during the test phase. Details of the 10-sample case can be found in annex 5 of the following Guideline, which can be downloaded here This step of the testing is applicable for the testing of all EDI Partners with the EMA. Other EDI Partners may decide to follow the same step.Step 6 This step of the production phase is applicable for all EDI Partners in the EDI process with the EMA and all other EDI Partners using their locally established pharmacovigilance system. In the production phase the EDI Partners acknowledge the validity of a Safety or Acknowledgement Message or an MDN, to be the same as an equivalent paper document for all legal and regulatory purposes and will not contest the validity of a Safety or Acknowledgement Message or an MDN effected by the use of EDI in accordance with the terms and conditions of this Guideline on the sole ground that it was effected by EDI. A copy of this Guideline can be downloaded here Any technical changes must be communicated immediately in writing between the EDI Partners. Major technical changes may require the re-initiation of the test phase as described above. The EMA is compiling medicinal product information for pharmacovigilance purposes. You can find more about this project here
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