Clinical trial disclosure
Clinical trial disclosure requirements are creating a secondary compliance burden for Trade and Geopolitical Risk teams, particularly where cross-border data sharing, export-controlled research, and foreign government-sponsored trials intersect with sanctions regimes. The U.S. Food and Drug Administration's 2023 final rule on clinical trial data submission under 42 CFR Part 11, combined with oversight activity from the European Medicines Agency and the U.S. Department of Health and Human Services Office for Human Research Protections, means disclosure obligations now touch supply chain provenance, foreign principal relationships, and technology transfer in ways most risk functions have not fully mapped. Cresthaven tracks every relevant agency action across this intersection so compliance teams are not reconstructing the picture from scratch.
Watch
- 42 CFR Part 11 final rule: deadline compliance for foreign-site trial registrations
- EMA transparency policy on trials conducted in sanctioned-country research facilities
- HHS OHRP guidance on foreign government co-sponsorship disclosure requirements
- Dual-use research of concern disclosures flagged in ClinicalTrials.gov filings
- BIS export control overlap with biologics trial data shared to APAC affiliates
Recent material activity in Trade & Geopolitical Risk
A selection of recent published briefs; this is not a complete archive.
OFAC adds entities to Non-SDN Menu-Based Sanctions List under PAIPA with blocking and financial prohibitions
OFAC added entities to its Non-SDN Menu-Based Sanctions List on October 19, 2026 under the Protecting American Intellectual Property Act of 2022. The designations impose blocking, lending, foreign exchange, and banking t…
Read a full sample brief →DGFT amends trade procedures to activate TRQ allocation mechanism under the India-New Zealand Free Trade Agreement
India's Directorate General of Foreign Trade (DGFT) issued Public Notice No. 33/2026-27 on October 17, 2026, amending the Handbook of Procedures, 2023 to incorporate tariff-rate quota (TRQ) procedures under the India-New…
Read a full sample brief →India's Ministry of Finance issues first-tranche tariff concessions under the India-New Zealand Free Trade Agreement
India's Ministry of Finance, Department of Revenue, issued Notification 32/2026-Customs on October 16, 2026, granting customs duty exemptions on goods imported from New Zealand. The notification gives effect to the first…
Read a full sample brief →China's Ministry of Commerce and Ministry of Science and Technology propose expanded technology export controls covering AI, biomedical, and energy storage sectors
China's Ministry of Commerce and Ministry of Science and Technology issued Announcement No. 48 of 2026 on October 16, 2026, opening a public consultation on proposed amendments to the Catalogue of Technologies Prohibited…
Read a full sample brief →CBP releases Harmonized System Update 2625 with Section 232 pharmaceutical tariff records and CPSC flagging changes
CBP issued Harmonized System Update (HSU) 2625 on September 29, 2026, containing 57 harmonized tariff records and 304 Automated Broker Interface records. The update incorporates Section 232 pharmaceutical tariff changes,…
Read a full sample brief →Canada's trade tribunal finds reasonable indication of injury from Chinese paperboard cups and containers dumping
The Canadian International Trade Tribunal (CITT) issued a determination on October 16, 2026, under preliminary injury inquiry PI-2026-004, finding a reasonable indication that dumping and subsidizing of paperboard cups a…
Read a full sample brief →Commerce issues final affirmative countervailing duty determination on high purity dissolving pulp from Brazil
The U.S. Department of Commerce issued a final affirmative countervailing duty determination on October 16, 2026, covering producers and exporters of high purity dissolving pulp from Brazil. The determination finds that …
Read a full sample brief →Commerce issues final affirmative LTFV determination for high purity dissolving pulp from Brazil
Commerce issued a final affirmative determination on October 16, 2026, finding that high purity dissolving pulp from Brazil is being sold, or is likely to be sold, in the United States at less than fair value. The period…
Read a full sample brief →Commerce issues final affirmative antidumping determination on high purity dissolving pulp from Norway
The U.S. Department of Commerce issued a final affirmative determination on October 16, 2026, finding that high-purity dissolving pulp from Norway is being sold, or is likely to be sold, in the United States at less than…
Read a full sample brief →USITC declines to review ALJ order adding dependent patent claims to GlobalFoundries semiconductor investigation
The USITC has declined to review an initial determination that allows GlobalFoundries U.S. Inc. to amend its complaint in an active Section 337 investigation. The amendment adds dependent claims 8 through 12 and 19 of U.…
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