Before a submission is evaluated for health and environmental considerations and for its value (including efficacy), it is first examined by Screening Officers of the PMRA’s Submission Coordination Division (SCD). The purpose of the initial screening is to make sure that submissions meet the format, content and fee requirements of the Agency before they are sent for detailed evaluation.

The screening process ensures that only complete, accurate and standardized submissions are brought forward for assessment. To this end, the Agency provides to industry detailed presubmission guidance on administrative procedures and data requirements. In the Screening Section, preliminary analyses of the studies are also carried out to determine if they are acceptable and whether they comply with international protocols.