In 2025, the United States implemented 28 CFR Part 202, a landmark regulation restricting cross-border access to sensitive personal and government-related data by foreign entities, particularly those associated with China, Russia, Iran, North Korea, Cuba, and Venezuela. This rule profoundly impacts global clinical research, biotechnology, and digital health companies operating or collaborating internationally.

In May 2025, the International Council for Harmonisation (ICH) released the draft M4Q(R2) guideline, reshaping the regulatory landscape for pharmaceutical quality documentation. This update to the Common Technical Document (CTD) introduces a data-centric, lifecycle-oriented framework for Modules 2 and 3—enhancing clarity, digital readiness, and harmonization across major regulatory jurisdictions including the US (FDA), EU (EMA), Japan (PMDA), Canada (Health Canada), China (NMPA), Brazil (ANVISA), and more.

Europe’s nicotine market is entering a new regulatory era marked by unprecedented convergence between national bans and EU-wide fiscal reform. From France and Belgium’s bans on disposable vapes to Spain’s sweeping controls on flavours and nicotine pouches, governments are acting rapidly to address youth use, environmental waste, and public health risks. At the same time, the European Commission’s proposed Tobacco Tax Directive (TTD) aims to harmonize excise duties on e-cigarettes, heated tobacco, and nicotine pouches—introducing consistent taxation across Member States by 2028.