Many companies consider regulatory intelligence so important that they create their own roles and departments for it.
This article clarifies what regulatory intelligence is, how companies can benefit from it, and where tools can provide support.
This article focuses on the medical device ecosystem, but the statements can be applied to regulatory intelligence at pharmaceutical companies almost without exception.
Regulatory intelligence is a systematic process of collecting, analyzing, and disseminating information about regulatory requirements, policies, and guidelines that affect the development, manufacturing, distribution, and surveillance and regulation of medical devices.
Source: Johner Institute
This includes gathering and analyzing regulatory information from various sources, including regulatory agencies, industry associations, and scientific literature.
"Intelligence" is not only to be interpreted as "intelligence" but also as "information" and "knowledge."
This is comparable to the CIA, the US "intelligence agency". It collects and evaluates information and passes on its findings to relevant recipients.
The goal of regulatory intelligence at manufacturers is to provide executives with the latest information on an ongoing basis. They need this to make informed decisions in the following areas:
Manufacturers are obliged to systematically record the regulatory requirements. ISO 13485 contains this requirement, e.g., in chapter 5.2.
Regulatory intelligence is important to a wide range of stakeholders involved in the development, manufacturing, distribution, monitoring, and regulation of medical devices. These include medical device manufacturers, regulatory affairs professionals, clinical researchers, and healthcare providers (see Tab. 1).
Demand for regulatory intelligence
See list in section 2
- Decide on the purchase of medical products
- Operate products in compliance with the law
- Inform patients in accordance with the law
- Assess safety, performance and availability of medical devices
- Prepare own employees for future requirements
- Inform manufacturers about these requirements
- Ensure conformity of products and manufacturers during approval and market surveillance
- Understand regulatory requirements
- Select markets for clinical investigations
- Plan and conduct clinical investigations in compliance with regulatory requirements
- Coordinate own plans with other legislators
- Model and anticipate the effects of regulation (see Regulatory Science)
Tab. 1: Stakeholders benefiting from regulatory intelligence
In order to achieve the above objectives, all regulatory-relevant content must be collected:
Sources now primarily include:
Publications in printed publications such as magazines are rarer. Physical circulars and notices are the exceptions.
Some information is not official but can only be obtained through personal contacts.
For medical devices, there are services and software applications that support the collection and evaluation of regulatory information.
These services perform many tasks for clients (e.g., manufacturers), such as collecting, (pre)evaluating, and filtering information. They also provide support in deriving the necessary measures.
Implementing these measures is always the task of the respective client (see Tab. 2).
Client/Customer (manufacturer, authority, notified body)
Filter information for client
Decide on measures
Tab. 2: Division of tasks between service provider and principal
Examples of measures include:
Service providers like the Johner Institute help with customized services and software even to track and ensure the implementation of measures.
Overall, regulatory intelligence plays a critical role in meeting the duty,
By providing access to regulatory information and analysis, tools help stakeholders make informed decisions about medical device development, regulatory compliance, and market access to gain a competitive advantage.
For most organizations, it makes good business sense to outsource work to service providers to benefit from "leverage" and higher-quality search results.