Strategic Regulatory Planning Flashcards

Which regulatory strategy is most appropriate when a company needs to launch a product simultaneously in the US, EU, and Japan?

Answer: Global regulatory harmonization strategy using ICH guidelines

A global harmonization strategy leveraging ICH guidelines enables concurrent submissions across regions by aligning data packages to shared standards.

What is the primary purpose of a Regulatory Affairs Strategic Plan (RASP)?

Answer: To outline regulatory milestones, resources, and risk mitigation for product development

A RASP aligns regulatory activities with business objectives by defining milestones, resource needs, and contingency strategies throughout development.

A company is developing a combination product (drug-device). Which US regulatory consideration is most critical early in strategic planning?

Answer: Determining the primary mode of action to identify the lead FDA Center

For combination products, FDA assigns jurisdiction based on primary mode of action (PMOA), determining which Center leads review and which pathway applies.

Which tool is commonly used in strategic regulatory planning to assess likelihood and impact of regulatory risks?

Answer: Risk matrix (probability × impact grid)

A risk matrix plots regulatory risks by probability and impact severity, enabling teams to prioritize mitigation efforts strategically.

A regulatory team is evaluating whether to seek Breakthrough Therapy Designation. What is the key eligibility criterion?

Answer: Preliminary clinical evidence must show substantial improvement over available therapies for a serious condition

Breakthrough Therapy Designation requires preliminary clinical evidence showing substantial improvement on a clinically meaningful endpoint over existing therapies for a serious condition.

In strategic planning for a generic drug, which factor most significantly determines the regulatory pathway in the US?

Answer: The brand drug's patent expiration date and market exclusivity status

Patent expiration and exclusivity periods (including 180-day exclusivity for first filers) are central to determining when and how a generic ANDA can be strategically filed.

What is the strategic advantage of using a pre-submission meeting (Type B meeting) with FDA during drug development?

Answer: It allows sponsors to align on study designs, endpoints, and data requirements before costly investments

Type B meetings (including End-of-Phase 2 and pre-NDA meetings) allow sponsors to gain FDA feedback on development plans before committing resources, reducing submission risk.