An exploration of regulatory intelligence as it applies to the development of medicines
Previously I have discussed how RSS news feeds benefit regulatory professionals by streamlining the process of keeping up to date with new information as it emerges.
Unfortunately, we have also seen that not all regulatory agencies have RSS feeds. This leaves the problem of what are the best ways of keeping up to date with agencies, especially those that do not have RSS news feeds. In this article, I will discuss some of the tools that I have found very helpful in achieving this.
In a previous post I explored how RSS can be useful to regulatory professionals. However, this is only as useful as the availability of RSS feeds. Although it is clear that not all regulatory authorities provide RSS feeds, it is interesting to note that most national authorities in the EEA do publish them. For this reason, I thought it would be helpful to share those news feeds which I have found on authority web sites in the EEA.
This week has seen one RSS reader disappear and an announcement that another one will disappear later in the year. Firstly, LinkedIn have announced that the inclusion of RSS feeds in their Groups has been discontinued. This became effective on 15 March 2013. Also this week, Google have announced they are shutting down Google Reader. This will be effective from 1 July 2013.
Despite these shifting sands in the tools available to read the RSS news feeds, such as those of the regulatory agencies, the RSS standard is here to stay and there are many other good tools which can be used to read and digest these vital sources of regulatory information.
It is crucial to successful regulatory intelligence to be able keep track of the changes which are published, often daily, by the regulatory agencies. The volume of available data published by them is growing day by day as the medium is embraced more and more for the effective dissemination of the latest regulatory requirements and expectations. With recent transparency initiatives, the volume of changing information is increasing further.
In my article last year in TOPRA’s Regulatory Rapporteur, entitled The World Wide Web as the ultimate regulatory intelligence database, I discussed various data formats which are used on the World Wide Web, many of which are useful to regulatory professionals.
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.