Legislation- A-Z Guide 2021 S.I. serve innovation extract in graphic or tabular form the taking the time to collect better quality information one is looking for. Examples files, but rather would appear to reflect can be found in the visual additions of the distrust following the many adverse opi- present paper. nions together with the complexity of the dossiers. The relationship between the A lack of engagement cost of developing proprietary studies and and a success rate that the risk of rejection of the file rests against does not improve! the industry. Indeed, our analysis shows that of the 138 files submitting a request As of December 31, 2020, 297 files had for proprietary data protection, only 33 been reviewed with the results of expertise received a favorable opinion, represen- published by the NDA panel, represen- ting a success rate of 23.9% (compared ting only 38 additional files in the past 5 to 32.1% for the 159 files that did not years (FIGURE 1). The overall success rate present proprietary data). remains the same with 28.3% favorable A detailed analysis of the graph (FIGURE 1) opinion. It is even lower (18.4%) consi- provides a closer look at these thirteen dering only the period 2016-2020. The years of published opinions. The distri- small number of health claims files filed bution of claims’ type is stable with 55% over the past five years would therefore (compared to 52% at the end of 2015) of not be an indication that petitioners are opinions on functional health claims based 027 FIGURE 1: Evolution of NDA panel published opinions based on file type Analysis by RStudio software. In parentheses for each year, the total number of files published. Above the central axis the favorable opinions, and below the unfavorable opinions. News on Functional & Health Ingredients \ Special Issue \ A - Z Health Ingredients 2021 \ ■