Summary bridging and addendum reports confirmed dead in ICH benefit-risk reporting guideline
This article was originally published in SRA
Summary bridging and addendum reports are categorically not needed under the new international guideline on periodic reporting of a drug's benefit-risk profile - E2C(R2) - according to a senior participant in the guideline development process.
You may also be interested in...
The European Directorate for the Quality of Medicines & HealthCare is proceeding carefully to find the right balance between serving the diverse requirements of various stakeholders that make use of its ‘certificates of suitability.’
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.