Regulatory Intelligence is not...

Having considered previously what is the essence of regulatory intelligence (RI), to help clear up some confusions and misconceptions it is also worth considering some other disciplines which are distinct from (and often confused with) RI.

Business intelligence

Business intelligence seeks to analyse large amounts of data (frequently referred to as “big data”), and transform it into meaningful and useful information to improve how an enterprise conducts its business in a particular field. This will often include looking at their production and sales operations to assess their likely impact in the specified area.

Competitive intelligence

Competitive intelligence analyses the external environment focusing on direct and indirect competitive threats and opportunities in a particular field. The principal aim is to mitigate commercial risk including the identification of likely competitors and establish their capabilities, vulnerabilities and intentions.

Regulatory information updates

Over the years I have noted that there is a widely-held misconception that RI is all about dissemination and consumption of regulatory news and updates, such as the publication of new guidelines or legislation. If we consider the core elements of intelligence as previously defined, it is clear that this boils down to both the acquisition and the application of knowledge. Such updates clearly incorporate the acquisition of knowledge. However, the application of that knowledge is often sadly neglected, resulting in an undigested deluge of information which leaves little time for those consuming the information to consider its implications.

Regulatory intelligence is...

The role of regulatory intelligence is to consider all relevant information sources and to determine the value of the knowledge contained therein and how it should be applied in each particular case. This must be done with reference to the goals and objectives in the development of each medicine or potential medicine for which it is being considered.

In contrast, the output of regulatory news streams and updates is a high volume of minimally digested information. Whereas the output of proper regulatory intelligence directly impacts regulatory strategy by clearly communicating the implications of the evolving regulatory environment.

How does regulatory intelligence relate to these other disciplines?

Although the above summary shows how the discipline of regulatory intelligence differs from business intelligence and competitive intelligence, there is much interdependency among them which requires joined-up thinking to ensure appropriate synergies are maximised. So, for example, in considering the competitive landscape it is vital to consider what regulatory options are likely to be utilised when developing a particular medicine and to leverage the understanding of the strengths and weaknesses of each option in given scenarios. Conversely, when analysing the regulatory options and evaluating the likely outcomes of these, it is essential to understand the competitors, their intentions and any dialogues which may already be underway with regulators, which can set precedents that may impact regulatory strategy and lead to competitive advantage.

I realise this article overlooks much detail which needs to be take into account. However, I think it highlights some important misconceptions around regulatory intelligence, which needs more detailed consideration.