As part of a review of a TOPRA resource on regulatory intelligence (RI), a short survey was conducted among the RI SPIN group members to find out what RI means to them in their specific role.
Out of 41 respondents, 16 worked in an organisation with a separate RI function. Most (n=38) work in a company employing >1,000 people, and three work in a company employing 100–1,000 people. There was wide diversity in how the industry respondents viewed RI, although they generally acknowledged the importance of being aware of RI developments for high quality dossiers and useful interactions with health authorities. For companies with a separate RI function, most of them see benefit in having their own proactive “RI champions” to perform gap analyses between the present and the future, comment on draft guidelines, and share industry’s perspectives in the definition of new regulation paths as part of international expert groups and trade associations.
The RI function is also seen as pivotal in building development strategy and informing decision-making at the highest management level.
Of the respondents without a separate RI function, 19 (76%) would like to see one created, mainly to “ensure people look beyond the now” and to have a more structured RI process. For smaller companies without sufficient resources, however, the RI function has to be integrated into other more classical functions, relying on existing tools.
A common theme for TOPRA to consider was to help to make the broad range of RI activities and tools more visible and develop resources to support members in this function.
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