Regulatory intelligence is an integral part to exploit effectiveness and guidance for the regulatory professional, and is at the heart of every well-informed regulatory decision.
Regulatory intelligence is an essential aspect to succeed in the regulatory landscape. Regulatory data must be harnessed and turned into actionable information as regulatory documents are readily available online and the right analysis, can deliver a wealth of insight
Regulatory Data: Potential Uses
Some of the many ways regulatory data can be useful include:
- Identify issues that a FDA district office frequently cites in inspection reports and help industry to cover the ground.
- Survey the competitive landscape to formulate regulatory strategies and gain business intelligence
- Monitor approvals of new products, provide valuable regulatory input to sales and marketing
- To be abreast of labeling changes to competitive products, to assess whether the changes might impact the market
- Analyze adverse event reports
- Assess review times for a category of product or reviewing division to detect trends and compare results
- Keeping up with warning letters that might affect the market and to see shifts in policy implementation
- Screening potential suppliers or distributors to guard against supply chain interruption
- Monitor adverse event and recall data to detect problems in similar products to better inform the design process for new ones
- Keeping current with the evolving requirements in guidance documents
- Aiding in the selection of clinical investigators
Regulatory intelligence can be summarized “as actionable intelligence derived from assessment of the regulatory landscape.” Regulatory landscape can comprehend various types of publicly available information, such as:
- Product approvals
- Adverse event reports
- Guidance documents
- Recent actions taken by government agencies
Finding correlations between the massive amounts of data provided in hundreds of separate public databases that are not cross-referenced can prove strenuous but, the emerging field of regulatory intelligence has such tremendous capacity to inform the regulatory process that it should be an essential component of every regulatory professional’s toolbox.
“RI can advance product lifecycle (value chain) in terms of procedural, technical, scientific and strategic input. Core roles include general information gathering and tracking legislation, followed by information dissemination and use. Procedural intelligence can include advising on marketing authorization applications (MAA) format and procedures, content and copy requirements in Europe and subsequent rest-of-the-world dossier preparation, plus compilation of internal working practice documents, templates and policies.”