Regulatory Affairs Support
& Certification Insurance

Coverage triggers when a regulatory authority issues a Complete Response Letter (CRL), Refuse-to-File (RTF) action, clinical hold, import alert, warning letter, or equivalent formal rejection or enforcement action against a covered application. Coverage also triggers on voluntary withdrawal arising from a covered regulatory event.

Pre-submission advisory opinions, informal comments, and minor deficiency letters do not trigger coverage unless they result in a formal rejection or delay to approval. Your account manager can review your specific submission pipeline to identify coverage attachment points.

Certification insurance coverage attaches to regulatory submission applications, not clinical trial phases. Products in Phase II or Phase III trials are eligible for coverage once an IND, CTA, or equivalent application is active with a regulatory authority.

Clinical hold coverage – which protects against FDA or EMA-issued clinical holds on ongoing trials – is available as a separate endorsement. This covers incremental trial costs and revenue timeline delays resulting from a clinical hold issued by a covered regulatory authority.

Access to the J.D. regulatory affairs consulting network is included as a covered expense within the pharmaceutical certification coverage program. Following a qualifying coverage trigger event, J.D. will assign and coordinate consultant resources at no additional cost to the policyholder.

Pre-trigger strategic consulting – engaging consultants before a rejection event for submission strategy – is available to policyholders at preferred rates but is billed separately. Some program tiers include a pre-trigger consulting allocation; contact your account manager for program details.

J.D. Insurance is currently licensed to write pharmaceutical certification coverage in 28 countries including the United States, all major EU member states, the United Kingdom, Canada, UAE, Saudi Arabia, Qatar, Singapore, Japan, South Korea, Australia, Brazil, South Africa, and Israel. A full list of licensed jurisdictions is available upon request.

Multi-jurisdiction programs – covering simultaneous applications in three or more countries – are structured as unified master policies with local admitted components where required by regulation. Additional jurisdictions under active licensing review include several Southeast Asian and Gulf Cooperation Council markets.

Lost revenue is calculated as the difference between projected revenue based on the originally anticipated approval date and actual revenue received during the delay period. Projections are established at policy inception using a combination of internal company forecasts, comparable product launches, and independent market analysis provided by J.D.'s actuarial team.

Revenue projections are verified against audited financial records and must be supported by board-approved forecasts or equivalent documentation. Coverage applies from the date of the qualifying regulatory action through the date of actual market approval, subject to the policy period and coverage limit.

Deductible periods and maximum indemnity periods vary by program tier. Contact your account manager to review the revenue calculation methodology applicable to your product portfolio.