OHSU

Dossier Process

Information for Pharmaceutical Manufacturers

The primary process for pharmaceutical companies to submit evidence to the Project will be by dossier submission. Submitting a correctly completed dossier will ensure that the evidence submitted by a company will be fully reviewed. Good quality evidence that is relevant to the key questions will be integrated into the Project reports and updates. We encourage submission of any relevant evidence or analysis during the process.  

Electronic submission is now required.

The Center will notify pharmaceutical companies manufacturing or promoting drugs included in a review by certified mail. Notice will be sent to a company representative designated to receive notice. Key questions for the systematic review and the dossier submission protocol will be provided with the notice. Companies will have 8 weeks from the date notification is mailed to submit a dossier.  The cut off for new drugs to be included in a DERP Review is the same date that dossier submissions are due. After this date has passed, new drugs will be acknowledged in the report but not included in the drug class review.

To ensure that their evidence is considered, companies must submit evidence in the format provided by the Center. Please read the Dossier Submission Protocol section below:

Dossier Submission Protocol

Center Process for Release of Evidence

All materials submitted to the Center will be available to the public upon the release of a final systematic report or update. All evidence included in the report will be listed in the report. The Center will:

  • Maintain a master copy of all dossiers.
  • Distribute copies of dossiers available at cost and upon request at the time of release of the related final report.
  • Notify the requesting party of the cost of the request within three business days of the request if . Cost will include a flat charge, a per-page copying fee  and a shipping charge if applicable.
  • Ship dossier to the requesting party within three business days of receipt of payment if applicable.

By sending and submitting a dossier to the Center for Evidence-based Policy, regardless of any markings or statements of confidentiality contained in or on the dossier, the Company authorizes the Center to:

  • Use any or all of the information in the dossier in reports (public or not),
  • Make any and all information in the dossier available to the public, and
  • Send a copy of the entire dossier to any individual or entity requesting the dossier from the Center.

The Center shall accept all dossiers and shall have no obligation to return submitted dossiers to the company, irrespective of any markings or statements of confidentiality contained in or on the dossier.
 
All information submitted to the Center for Evidence-based Policy may be available to the public.  Any and all markings or statements of confidentiality shall be considered null and void.

To request a set of dossiers for a particular drug class, please contact Alison Little at littleal@ohsu.edu.

Note

The Center will release only the full set of dossiers submitted for a drug class.
Individual dossiers will not be copied and released.