L'impact de la nouvelle administration américaine sur le paysage réglementaire

The regulatory landscape in the United States continues to shift under the new government that secured re-election in 2024, which is impacting sectors from global financial services to digital health. The administration maintains its deregulatory agenda, reshaping oversight in key industries such as pharmaceuticals, healthcare, technology, and environmental protection.

While these changes aim to drive economic growth and reduce bureaucratic hurdles, they also spark debates around safety, regulatory compliance, and long-term industry stability. These shifts present key considerations for international businesses navigating the evolving regulatory landscape in the U.S., UK, and the EU.

Politiques de déréglementation : réduire les formalités administratives

One of the administration’s key regulatory initiatives remains the “2-for-1” rule, requiring that for every new federal regulation introduced, two existing ones must be removed. This approach continues to lower compliance costs for businesses, particularly small enterprises and encourages economic expansion. However, critics argue that it places deregulation above consumer protection and industry accountability.

Additionally, the president of the United States has signed an executive order granting the White House greater control over independent agencies such as the Federal Election Commission and the Securities and Exchange Commission. These agencies must now submit major regulations for review by the Office of Management and Budget and appoint White House liaisons within their structures. This approach also influences the broader regulatory framework by reducing regulatory reporting burdens and shifting accountability structures.

Réglementations FDA et du secteur de la santé

The Food and Drug Administration (FDA) is undergoing significant regulatory shifts during the administration’s second term. A key initiative focuses on accelerating drug approvals, allowing new treatments to reach the market more quickly. The FDA is streamlining its review processes, particularly through programmes designed to expedite medical product releases. These developments reflect a changing regulatory landscape in public health oversight and medical device governance.

The administration is also intensifying efforts to lower pharmaceutical prices and increase market competition. New initiatives aim to revise pricing mechanisms and reduce reliance on imported medicines. However, recent restructuring efforts within federal agencies have led to significant staff reductions at the FDA and CDC, raising concerns about their ability to fulfil public health responsibilities and meet evolving regulatory compliance standards. These developments may also prompt renewed scrutiny of regulatory reporting practices across healthcare and life sciences.

Le retrait de l'OMS et son impact sur les évolutions réglementaires

The U.S. has now finalised its withdrawal from the World Health Organization (WHO), impacting international health coordination efforts. Federal agencies such as the FDA and CDC must now develop alternative regulatory frameworks for global health governance and oversight. The departure from WHO raises concerns about how effectively U.S. public health agencies can respond to global health crises and maintain alignment with international standards. This shift could reshape public health governance and strain operational resilience in cross-border regulatory coordination.

Impact du retrait de l'OMS sur l'ISO 13485 et l'harmonisation avec la FDA

L'une des principales conséquences du retrait est le ralentissement potentiel de l'alignement ISO 13485 avec les réglementations de la FDA. ISO 13485 est une norme internationalement reconnue de management de la qualité pour les dispositifs médicaux, tandis que la La FDA suit son propre cadre réglementaire (21 CFR Part 820). Les efforts visant à rapprocher ces normes ont été précédemment soutenus par une collaboration internationale, notamment l'implication de l'OMS et du International Medical Device Regulators Forum (IMDRF).

Sans la coordination de l'OMS, les États-Unis doivent établir des mécanismes alternatifs pour dialoguer avec les régulateurs mondiaux. Ce changement pourrait entraîner :

• Les exigences réglementaires divergentes héritées de l'UE compliquent l'accès des fabricants américains aux marchés internationaux.
• Augmentation des coûts de conformité, les entreprises devant s'adapter à de multiples normes.
• Processus de certification et d'approbation plus lents pour les dispositifs médicaux développés aux États-Unis.

Some analysts predict that the FDA may tighten domestic regulatory requirements to compensate for the lack of international coordination. However, this could introduce additional barriers for companies trying to comply with both U.S. and European standards. Companies will need robust adherence to regulatory responsibilities and clearer regulatory planning to operate across global markets.

Réglementations commerciales et économiques

The administration continues to pursue protectionist trade policies, expanding tariffs on foreign manufacturers. This impacts international supply chains and import regulations, prioritising domestic manufacturing and revising trade agreements. The government has also pushed for stricter domestic manufacturing requirements in key industries, including pharmaceuticals, semiconductors, and energy.

Réglementations sur la technologie et la protection des données

The current administration remains firm on regulating the technology sector. Planned amendments to Section 230 of the Communications Decency Act aim to reduce legal protections for online platforms. Meanwhile, evolving data protection policies focus on national security concerns and reducing foreign influence in the tech sector, contributing to a broader shift in the regulatory climate.

A significant shift came when the president signed an executive order revoking previous artificial intelligence (AI) regulations, signalling a new approach to AI governance. This marks a strategic move towards clearer regulatory expectations for AI systems, generative AI models, and their applications across sectors. The decision is expected to influence innovation policy and drive proposals around the ethical use and real-world deployment of AI tools, particularly in areas such as AI ethics, national security applications, and global competition in emerging technologies.

Planification de la conformité dans un paysage réglementaire en évolution – résumé

The new U.S. administration’s regulatory shifts prioritise economic growth and national security but bring challenges in compliance, international trade, and public health oversight. Businesses must stay agile, adapting to evolving standards in healthcare, technology, and trade while preparing for potential regulatory divergence. Companies operating globally should establish alternative compliance strategies, monitor changes in FDA and data privacy rules, and anticipate shifts in trade policies.

Proactive engagement with industry groups and regulatory bodies will be key to navigating this changing landscape and ensuring long-term stability in an increasingly complex regulatory environment. In doing so, they must also monitor proposals, prepare for regulatory investigations, and align with the broader global financial services regulatory framework. This requires regulatory adaptability, clear strategic planning, and close attention to sector-specific requirements.

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