Updated :  06-Nov-2008

Standard Operating procedure (guidance documents)

1. General outline

In order to start the procedure, the completed 'Application Form for Validation and Certification of Diagnostic Tests by OIE' (one complete copy of the application in a suitable PC-compatible medium, e.g. CD-ROM [preferred electronic format: Word], and one copy in paper format) and the applicable fee should be sent by the applicant to the OIE Director General.

Director General
OIE Procedure for validation and recognition of the diagnostic test
OIE
12, rue de Prony
75017 Paris
France

The OIE Central Bureau, through the OIE Secretariat for Validation, Certification and Registry of Diagnostic Assays (OIESVCRDA), will be able to provide more procedural guidance during the pre-submission phase and to prepare the assessment process.

OIESVCRDA: Dr François Diaz
Secretariat for Validation, Certification and Registry of Diagnostic Assays
Scientific and Technical Department
OIE
12, rue de Prony
75017 Paris
France
Tél: 33 (0)1 44 15 19 69, fax: 33 (0)1 42 67 09 87
Email: f.diaz@oie.int

The conditions, including the date of submission, should be defined in accordance with the OIESVCRDA in order to optimise the timing of the procedure.

After receipt of the above-mentioned elements the OIESVCRDA will check the form and process the application within 30 days.

During this phase, the OIESVCRDA is allowed to ask the applicant for further information to obtain a valid application (should this be the case the clock is stopped while awaiting its arrival).

Most of communication between OIESVCRDA and other persons involved in a procedure will be done by email. Receipt of e-mail will be acknowledged electronically.

When the application is considered valid, the applicant will be informed by the OIESVCRDA of the names of the chairperson and reviewer(s) for the diagnostic test assessment, a procedure number and a timetable for assessment.

The OIESVCRDA, in consultation with the President of the OIE Biological Standards Commission (BSC), should propose to the OIE Director General an appropriate panel of reviewers included in the OIE list of approved reviewers.

The total duration of the procedure will be 135 days. Once the clock starts, the reviewers should provide an initial report within 30 days to the CRP.

The CRP should prepare a consolidated report and liaise with the other reviewers. If questions are to be sent to the applicant, the clock is stopped until answers are received.

An assessment report should be sent by the CRP to the OIESVCRDA before day 60. If any questions arise, the OIESVCRDA will send them to the applicant.

After receipt of the answer to the questions and acceptable clarification, the CRP, in consultation with the reviewer(s), should provide a final assessment report with a clear proposition within 15 days.

At the next meeting of the BSC the CRP, if necessary, will present the assessment report and conclusions. If successful, the BSC will then propose to the OIE Director General to place the diagnostic test on the register.

The OIE Director General will take the final decision. The OIESVCRDA will notify the applicant within 15 days of a successful application and the information will be published on the OIE web site stating that the test has been approved by the OIE Director General and is proposed for inclusion in the register. The final inclusion in the OIE register will be discussed and voted on by the OIE International Committee (comprising the Delegates of the Members Countries) during the General Session through the presentation of a Resolution drafted by the BSC containing a list of recommended validated and certified assays to be registered by the OIE. The final inclusion is effective within 7 days of the vote of the OIE International Committee.

In cases where the BSC recommends that the test not be included in the register, the applicant may appeal the decision in writing, but at his request, the applicant could appear before the BSC to give an oral appeal.

If the appeal is rejected by the BSC, the final decision of the Director General will be notified to the applicant by the OIESVCRDA.

Once a diagnostic test is placed on the register, any changes to the test must be declared and justified in advance before approval for implementation.

The OIE Central Bureau, through the OIESVCRDA, will require an annual declaration from the applicant stating that the test remains valid and should be retained on the registry. Every 5 years, the OIE will insure that the diagnostic test remains within the current state of the art.

2. Guidance documents

- Standard Operating Procedure - text -
- Standard Operating Procedure with Appeal Procedure - detailed timetable -

3. Schema of the procedure

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