2026 Life Sciences Regulatory Updates for North America

In the upcoming year, across major North American jurisdictions, regulators are modernizing policies to accelerate innovation while strengthening safety and quality oversight. From the FDA’s alignment with ISO 13485 and draft reforms in accelerated approvals and biosimilar pathways to Health Canada’s agile licensing and clinical trial modernization, these changes reflect a shift toward risk-based and data-driven quality management, and globally harmonized standards. Mexico’s reliance pathways and national pharmaceutical strategy further underscore the trend of regulatory agility and local manufacturing incentives.  

For firms operating in this space, these updates mean rethinking compliance strategies, investing in digital systems, and embedding quality and risk management into every stage of development and commercialization. 

The United States of America 

Implementation of New QMS Regulation (QMSR)

The FDA’s Quality Management System Regulation will replace the existing Quality System Regulation and add ISO 13485:2016 alignment, requiring manufacturers to revise QMS processes accordingly. 

This update provides multi-market regulatory compliance, which is especially beneficial for manufacturers already ISO‑certified. There will be greater emphasis on risk-based processes beyond design validation, which will have to be embedded throughout the lifecycle of products. Additionally, inspectors will now have access to documents outlined in ISO 13485 such as internal and supplier audits, along with risk management documentation. 

For ensure that companies are compliant with new QMSR requirements, conduct a gap analysis to benchmark current company QMS against ISO 13485:2016 and identify gaps in risk, supplier management, competence, process validation, and CAPA systems. Additionally, companies should implement and document robust supplier qualification and performance oversight processes to strengthen risk and supplier management. More information on this update can be found on our recent blog.

Accelerated Approval Reform and Biosimilar Guidance

While not still a draft guidance, the FDA released information in late October 2025 detailing new draft guidance to simplify biosimilarity studies and support interchangeable status of drugs.  

In the draft guidance, the FDA recommends that for proposed biosimilar with highly similarity to its reference product, an appropriately designed human pharmacokinetic similarity study and an assessment of immunogenicity may be sufficient to evaluate clinical equivalency terms of safety, purity, and potency. A Comparative Efficacy Study (CES) may not be necessary to support a demonstration of biosimilarity in circumstances such as these. The elimination of routine CES could save developers money and cut down on development time. 

To prepare for the processes outlined in this draft guidance, companies can try to identify product candidates where analytical comparability is sufficient to demonstrate biosimilarity and utilize analytical and immunogenicity data to support submissions. It could be helpful to set up pre-IND or BLA meetings to confirm when CES studies are necessary and when analytics packages to justify reliance on non-clinical data. For more information, read the draft guidance on the FDA website.

Canada 

Clinical Trials Modernization & GCP E6(R3) Implementation

Health Canada published its Notice to Stakeholders on Oct 17, 2025, which announced the effective adoption of ICH E6(R3) GCP on April 1, 2026, following a six month preparatory period.  

This update shift clinical monitoring from one-size-fits-all toward Critical‑to‑Quality (CtQ) factors, which can bolster participant safety and data integrity through proportional oversight and optimized resource allocation. This update also supports decentralized trials, eConsent, digital data systems, wearables, and real-world data collection, making Health Canada aligned with global regulatory trends from EMA, FDA, and other ICH members. 

Firms operating clinical trials in Canada can leverage the next few months to pilot new approaches that specify CtQs, update training for clinical, QA, and regulatory teams on key E6(R3) principles, and update SOPs and QMS documentation to reflect this change. More information on this update can be found at Government of Canada website.

Medical Device License (MDL) Guidance
Health Canada Guidance on Managing MDL Applications published Nov 21, 2025 and coming into effect Feb 2, 2026, details new timelines, deficiency communications, market authorization times, and Regulatory Enrollment Process (REP)/Common Electronic Submission Gateway (CESG) requirements.  

Starting 2026, all Class II–IV MDL applications, including amendments, responses, unsolicited info, and withdrawals, must be filed via the REP and the CESG. Email submissions will be made obsolete. Supporting this initiative, the new Market Authorization Time metric will be used, which measures the total duration from submission to issuance, including pauses and extensions, to add transparency and accountability to the licensing process. In conjunction, Health Canada will set specific administrative screening, technical review, and overall review timelines for Class II–IV licenses and use a tiered approach involving screening deficiencies, regulatory clarification requests, and additional information letters to provide clear communication during evaluations. 

Firms operating in the medical device space in Canada should register and onboard relevant staff and systems to use REP and CESG, and update template formats to reflect this change. Furthermore, new administrative and technical screening benchmarks should be incorporated into regulatory timelines and project planning, along with the submission-to-approval window to improve time-to-market forecasting. More information on this update can be found on Government of Canada website.

Mexico 

COFEPRIS Reliance Pathway for Drugs & Medical Devices

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) issued a new update in August 2025, aiming to consolidated multiple device registration types into unified processes and reduced review times, with the updates coming into effect in October 2025.  

This update merged a number of application modes for raw materials, finished products, and medical devices into permits for imports, with the aim to reduces administrative and logistical delays. Firms working in this space should map out the new, simplified permit process and ensure contracts, labeling, and documentation all align with electronic submissions and newly consolidated permits. For more information, visit the official COFEPRIS website here (Spanish).

National Pharmaceutical Strategy & Local Manufacturing Incentives

Per the Official Gazette of the Federation, a new Presidential decree was announced in mid-2025, aiming to incentivize local production of drugs in Mexico starting in 2026. 

As outlined in the Decree, procurement will factor in bidders with domestic manufacturing, R&D, and innovation capacity for drug products including vaccines and biologics, and investments focused on Development Programs with Wellbeing Components (PODECOBI).  

Similar to the previously mentioned COFEPRIS update, companies can expect improvements to market entry with accelerated and expedited approvals and reviews for protocols, certificates, and import and export procedures. Companies looking to take advantage of this initiative should verify their alignment with decree criteria, such as domestic facilities in Mexico, R&D presence, and innovation projects. For more information on this Decree, visit the official release here (Spanish).

Conclusion 

Successfully navigating this new regulatory landscape requires awareness, operational readiness, and robust quality systems. Companies that adapt early will gain competitive advantages in speed-to-market, cost efficiency, and global alignment. Tools like ACE offer an integrated solution to manage evolving compliance requirements, streamline documentation, and support risk-based processes across clinical, manufacturing, and post-market activities. By leveraging PSC Software’s expertise and technology, firms can stay ahead of regulatory changes, ensure audit readiness, and confidently pursue innovation in a rapidly transforming life sciences environment.