What is Regulatory Intelligence (RI)?

If we will search for RI anywhere we will be getting many results and definitions. The act of gathering and analysing publicly available regulatory information. This includes communicating the Implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy and legislation.

Regulatory Information collectively comprises of three main segments which are followed while performing Regulatory Information activities:

• Gather Data: RI professionals perform research about regulatory norms as per a particular product in a particular geography. As far as collecting relevant regulatory information is concerned, there are a lot of sources that RI professionals leverage to consolidate their research material.

• Analyse Information: This gathered data needs to be filtered out to obtain relevant information as per the purpose. The data filtered is then rearranged having relevant information required according to latest trends and patterns in the regulatory industry. Latest changes in regulatory and guidelines need to be implemented.

• Regulatory Strategy: The key purpose to perform the above stated undertakings is to come up with the most appropriate and practical regulatory strategy for a company. Different products have different regulatory guidelines in different countries. This is why experts propose a plan of action that outlines an approach as to how to go about regulatory actions for the target distribution markets. However this plan of action is never a task done. It continuously goes forward as the mandates in the regulatory space change. This function of RI typically conducts the following activities:

• Regulatory strategy, development plan or therapeutic area analysis for a product.

• Guidance interpretation and application.

• Due diligence

• Citizen’s Petitions

• Participation or observation of Advisory Committee or other public meetings.

• Identifying regulatory trends and anticipating effect on company and products.

• Monitoring health authority organisational changes.

• White papers or position statements.

Why is Regulatory Intelligence Important?

Provides the regulatory professional with information to:

– Identify opportunities.

• Broader indications, precise pre‐clinical/clinical development programs.

• Expedite development/increase efficiency.

– Identify possible pitfalls.

• Compliance issues, change in requirements for specific indication.

– Predict review times for product and/or change to product.

– Answer specific development questions posed by team.

Benefits of Regulatory Intelligence

• Increased compliance.

• Increase likelihood of marketing application approval.

• Shorten time from filing to approval.

• Increased efficiency.

• Optimize study design for regulatory endpoints.

• Optimize messaging about product benefit.

• Maximize target market potential.

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Author - SAMPRGMR