RAC Strategic Regulatory Planning 5

Question 1

In EU strategic planning, what is the strategic rationale for using the 'Article 8(3)' full application pathway versus the 'Article 10' generic pathway?

Accepted Answer

Article 8(3) is used for new active substances requiring a complete independent dossier of safety and efficacy

Answer

Article 8(3) requires a complete, independent application for new active substances where no reference product exists to rely upon, making it the pathway for true innovator products in the EU.

Question 2

A company is planning regulatory strategy for a biosimilar. Which study is uniquely required compared to a small-molecule generic?

Accepted Answer

Comparative clinical immunogenicity and pharmacokinetic/pharmacodynamic studies versus the reference biologic

Answer

Biosimilar development requires comparative PK/PD and immunogenicity studies versus the reference biologic because complex biological molecules cannot be characterized as identical through analytical testing alone.

Question 3

What does 'regulatory feasibility assessment' accomplish in early strategic planning?

Accepted Answer

It evaluates whether a product concept can meet regulatory requirements in target markets before significant investment

Answer

A regulatory feasibility assessment conducted early identifies potential development blockers, pathway options, and jurisdictional requirements before substantial resources are committed.

Question 4

When a regulatory strategy calls for pursuing Priority Review in the US, what additional planning is required compared to Standard Review?

Accepted Answer

More intensive FDA meeting interactions and readiness for a 6-month rather than 12-month review clock

Answer

Priority Review compresses FDA's review goal to 6 months (versus 10-12 for Standard), requiring the regulatory team to be prepared for faster agency feedback cycles and accelerated internal decision-making.

Question 5

Which scenario best illustrates a 'regulatory arbitrage' strategy?

Accepted Answer

Launching first in a jurisdiction with a more flexible or faster pathway, using that approval to support other filings

Answer

Regulatory arbitrage exploits differences in regional regulatory pathways or timelines to gain early market access and leverage that approval reference for subsequent global filings.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Strategic Regulatory Planning 5