Claim Substantiation

Claims are statements that represent pharmaceutical product’s content, information & benefits made for healthcare products. Different to a label that is only on product related material, a claim can be made anywhere- from a leaflet to a media commercial. A claim associated with a pharmaceutical product must be accurate as it determines the product and organization’s position in the market. As regulations vary from country to country it is important to determine what claims can be made in the region, for claim substantiation. The type of evidence that is needed for making the claims is crucial i.e., clinical data or in-vitro studies. Additionally, the risk-benefit information must also be identified for appropriate claim substantiation. Claim rejections that are made by regulatory authorities occur for many reasons such as lack of critical literature assessment or gaps along the clinical trial pathways i.e., inappropriate patient group, lack of control group, incorrect statistical test etc. It is essential to support claims with the correct evidence and keep updating the records to ensure that claims are true and not misleading in any way. All claims must follow the relevant regulatory authority’s guideline in the country that the product is to be marketed in.

DDReg’s team of labeling experts have worked on the validation and substantiation of consumer healthcare product claims. We utilize our in-house databases and bibliographical sources and our regulatory knowledge to work with legal teams or sponsor organizations to validate and successfully execute product claims.