The commenting procedure (hearings)

All interested persons, institutions or commercial companies can submit comments on the planned methods and interim results of benefit assessments, for example, to indicate additional important studies or arguments.

Within the framework of benefit assessments, interested persons and parties can submit comments on preliminary report plans (protocols), amendments to report plans, and preliminary reports. They can also submit comments on dossier assessments for the early benefit assessment of drugs pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). However, this commenting procedure is not conducted by IQWiG, but by the Federal Joint Committee (G-BA).

Comments submitted to IQWiG must conform to certain formal requirements in order to be considered.

Summary of the most important requirements:

  • Deadlines: The deadline for comments is at least 4 weeks after publication of the relevant document. The exact deadlines are published on the relevant project webpages. In addition, current commenting procedures are listed in an overview.
  • Submission of comments: comments must be submitted in writing. In order to meet the deadline, the punctual receipt of the comment per e-mail by the Institute is sufficient. If a comment is sent by e-mail in advance, then the form for submission of written comments must be submitted in its original version within 5 working days after the deadline. After receipt of the comment by e-mail or post the Institute will confirm this.
  • Debate: If questions arise in the written comments, the Institute can optionally hold an oral debate. Only those persons are allowed to participate who submitted a written comment and disclosed potential conflicts of interest prior to the debate.

The detailed requirements are outlined in the relevant guidelines for comments. These are published together with all other required documents for submission of comments on the webpages of the relevant projects.

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Glossary entries