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.

Input: regulatory information

One of the key components to RI is the gathering of relevant regulatory information. This has led to some confusion among the communities of regulatory professionals, some of whom appear to think of this as synonymous with RI. As we shall see, although this is an important part, there is much more to RI.

What types of information need to be considered? The most obvious information type that springs to mind is written published information, such as that made available on the web sites of regulatory agencies (e.g. the EMA or FDA). Indeed, the DIA definition, by restricting RI to "publicly available information" even appears to imply this is the only information relevant to RI. However, information communicated orally, such as through professional networking and at conferences can also provide valuable information, which should not be overlooked. Furthermore, some written information, which is unpublished will need to be taken into account. For example, this can include internal company documents as well as personal professional notes.

Similarly there is a multiplicity of information sources which yield relevant information. Below are some examples.

• regulatory agency web sites
• training courses
• conferences and seminars
• professional journals
• corporate history
• personal professional history
• information about competitors' products
• results of searches

The effective acquisition and management of the regulatory information is vital to inform the next stage of RI.

Process: the analyses

The amount of regulatory information available to us is vast and continues to increase day by day. For this reason, the first important consideration is how best to filter that information, to separate the signals for which you are looking from the background noise. If this is done well the information should be narrowed down to include only data which are relevant to the particular purpose.

Further analyses will generally include interpreting the data in the light of its context. For given products consideration should be given to what precedents may have been established from related product types that may be relevant to the product being reviewed. Some attention should also be given to looking for patterns and emerging trends in the thinking of the regulators. At each step there is likely to be a need to further refine the filtration stage to re-examine available information in the light of findings. So the filtering and analysing steps can have several iterations to locate all relevant information.

The analyses are further complicated by the need to take into account the regulatory landscape for each country where a product may be registered. Differences in medical practice and regulatory agencies can result in quite different expectations in each country. This can lead to different regulatory strategies being required in each country, as well as affecting the order in which to approach the countries.

Output: the regulatory strategy

The analyses performed as part of RI ultimately are to inform the best regulatory strategy. This should determine how to approach the regulatory agencies in each country and in what order. It may be that a particular country has a completely different view due to, for example, differences in medical practice. For this reason, a decision may be taken to either not take a product forward in that country or to delay it until the product is properly established in other countries, so their differences do not skew how the product is used appropriately in the remaining countries. This is especially relevant with the EU, where there is a strong pressure to harmonise the prescribing information, in order to support the philosophy of the free movement of goods within the EU. In this way in is often more efficient to focus on the major countries who are likely to reach a consensus about the usage of a medicine, avoiding unhelpful delays in the medicine reaching patients. It is often helpful to take the medicine to different-thinking regulators at a later stage.

Regulatory strategy should be disseminated within the organisation developing a particular medicine. This enable each of the disciplines involved with taking the product to the patients to understand and contribute to the planning process.

Regulatory strategy is usually captured in a strategy document, which crystallises the current thinking for a given product. However, it is essential that this is never taken as being a done task. As the regulatory landscape is constantly changing and the product characteristics become better understood, it is essential to keep revisiting and updating the strategy in the light of new evidence.