ICH Requires More Benefit-Risk Information from Drugmakers in Common Technical Documents
Drugmakers will have to provide more benefit-risk information in common technical documents submitted to the FDA, European Medicines Agency and other regulators, under revised guidance from the International Conference on Harmonisation.
The document, M4E(R2), requires companies to assess a product’s strengths, limitations and uncertainties for the intended use, using available data. This will be the first benefit-risk assessment submitted to a regulatory agency, ICH says, so the focus should be on key benefits and risks, not all possibilities.
Under the current guideline, ICH M4E(R1), drugmakers must submit only general efficacy information, safety findings, optimal dose ranges and regimens, and known interactions.
For each key benefit, drugmakers should outline its nature, clinical importance and the difference in effect versus a comparator, ICH says. Characteristics of key risks include the frequency and severity of adverse events versus the comparator and whether they are tolerable or reversible.
The benefit-risk assessment should consider the extent to which the severity of the disease and the expected benefit of the drug might influence patients’ willingness to accept risk, the ability of patients or healthcare providers to determine if the drug is having the intended effect and the proposed labeling and risk-management activities needed to reach a favorable risk-benefit balance.
For drugs with multiple indications, the revised guideline also asks drugmakers to consider separate benefits and benefit-risk assessments for each indication, but says risks can be combined. Firms may also include available information about patient perspectives on benefits and risks associated with a drug.
ICH also made one change to the guideline’s section on product development, saying firms should include a brief overview of the major therapies currently used in the intended population and how they influenced development.
Comments may be submitted to the ICH secretariat at email@example.com until Feb.29, 2016. View the revised sections of ICH M4E(R2) — 2.5.1 and 2.5.6 — at www.fdanews.com/08-10-15-M4ER2.pdf. — Kellen Owings