There appears to be much confusion among regulatory professionals regarding what regulatory intelligence really is. So, to begin with, I think it is right to explore how regulatory intelligence has been defined.
In February 2000 Tony Cartwright offered the following definition of regulatory intelligence at a conference held in London on Global Regulatory Strategy.
Information from various sources is used to guide the development (e.g. wording of the SPCs for competitive products, national therapeutic guidelines, and regulatory precedent).Since then two Regulatory Intelligence Network Groups (RINGs) have offered definitions. The RING associated with the Drug Information Association (DIA) has proposed the following definition.
The act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.An independent EU-based RING has also come up with their definition, which is as follows.
Regulatory intelligence is the act of processing targeted information and data from multiple sources, analysing the data in its relevant context and generating a meaningful output – e.g. outlining risks and opportunities – to the regulatory strategy. The process is driven by business needs and linked to decisions and actions.To help pin down the essence of regulatory intelligence further, it is worth considering the accepted meaning as defined in a standard dictionary for the English language, The Oxford English Dictionary (OED). The word “regulatory” is defined as follows.
- serving or intended to regulate something
- control or maintain the rate or speed of (a machine or process) so that it operates properly
- control (something, especially a business activity) by means of rules and regulations
- set (a clock or other apparatus) according to an external standard
With regard to the word intelligence, the OED provides two principal definitions, as follows.
- the ability to acquire and apply knowledge and skills
- the collection of information of military or political value
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