HLT.05.01officeUnion-wide competence
Purpose and competence
Medicine benefit-risk determination is maintained for Drug review. Its scope follows the office’s mandate: Review a medicine for a stated clinical use against attributable efficacy and safety evidence.
Positive evidence for one indication is advertised as general approval
Record specification
Custodian and access
Drug review assessment lead → · Public records access procedureFinding and assessment question
- Instrument
- Medicine benefit-risk determination
- Illustrative question
- Positive evidence for one indication is advertised as general approval
- Assessable source material
- clinical studies; manufacturing controls; monitoring plan