Wednesday, 6 February 2013

What is Regulatory Intelligence? (definitions)

This blog aims to explore some of the issues and ideas around the field of regulatory intelligence as it applies to the development of medicinal products. Regulatory intelligence is a key part of helping to ensure that resources are appropriately focused to help companies develop effective medicines for treating patients.
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
The OED defines regulate as follows.
  • 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
Clearly, as it pertains to medicines, the appropriate definition refers to the control of the use of medicines by means of rules and regulations.
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
I believe the primary concern in regulating medicines is the correct acquisition and application of knowledge, rather than collecting information for either military or political purposes. This is reflected in the use such words as analysing and implications in the DIA definition and analysing and processing in the EU RING definition. These imply it is not just gathering information, but it is more importantly what you do with the acquired knowledge to inform the best approach to the development, and regulation, of much-needed medicines. Ultimately the goal is to benefit patients by ensuring optimal regulatory strategy.

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