Thursday, 28 February 2013

The essence of regulatory intelligence (RI)

The framework for the regulation of medicines grows more complex with each day. The development of new product types, the harmonisation of requirements and the addition of new countries to the EU all have resulted in an environment where it’s becoming increasingly hard to predict how the regulatory agencies will view new medicines.

At the same time we see an ever-increasing plethora of information becoming available. The drive for more transparency is ensuring that this trend continues to accelerate. Now, more than ever, it is important to know how to find relevant information amid the vast sea of data, filtering and analysing it in ways that can increase our understanding of the expectations of the regulatory agencies. As a result of these changes, the discipline of regulatory intelligence is becoming increasingly important to more accurately predict and manage these expectations at both the national and international level.

In the previous post on this blog we explored some of the definitions which help us understand what regulatory intelligence is. To further understand the meaning of regulatory intelligence (which I will refer to as RI in this blog) we need to consider what its practice entails. From examining the definitions it is clear that RI includes the gathering of key information of regulatory significance, which is then processed and analysed to understand its relevance and implications. The output of these analyses is ultimately the regulatory strategy, which is then disseminated to interested parties.

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.