Sarah Bunyan
The green transition is not a single milestone, it is an ongoing evolution.
Regulatory requirements across inhaled and nasal drug development and delivery are evolving at pace. Today’s regulatory teams are navigating a landscape defined by sustainability mandates, deeper supply chain scrutiny and changing expectations around how evidence is generated and assessed.
Within the sector, this shift presents both risk and opportunity. Those who anticipate change can protect timelines, portfolios and supply continuity. Those who respond late may find themselves redesigning materials, reformulating products or navigating unexpected data requirements.
At Bespak, we are seeing that as the industry moves deeper into the green transition, regulatory foresight is emerging as one of the most powerful strategic tools available to product and technology innovators within the inhalation industry.
From process-driven compliance to strategic partnership
Regulatory affairs as a function has changed significantly over the past decade. Historically, the role centred on interpreting guidance and compiling submissions once development decisions were largely made. Today, that reactive model is no longer enough.
Regulatory considerations must now be embedded from the outset of a programme. Decisions around propellants, materials, device configuration and even modelling strategies carry regulatory implications. Risk-based thinking is essential. Global markets must be considered from day one.
As such for Pharmaceutical and medical device manufacturers, early regulatory involvement reduces late-stage surprises and costly rework. It also strengthens scientific advice interactions and builds confidence in the submission strategy. In a regulatory environment that continues to evolve, proactive engagement is key.
Kigali Amendment: 10 years later
When the Kigali Amendment was adopted in 2016, it committed nations to phasing down hydrofluorocarbons (HFCs), the propellants used in pressurised Metered Dose Inhalers (pMDIs). Nearly a decade later, the requirements for the pMDI inhalaler industry are clear, well defined and being implemented.
In the early phase of the transition to next generation propellants, uncertainty was unavoidable. Regulatory pathways were still evolving, expectations differed across regions, and companies were required to make long-term development decisions without established precedent.
Since then, progress towards global alignment has been steady. The first regulatory filings and approvals for Next generation propellant pMDIs have begun the process of clarifying data expectations, technical requirements, and review timelines. Dialogue between regulators and industry has become more structured, reducing ambiguity and supporting more predictable development strategies.
This trend towards harmonisation extends beyond propellant transition. In Jan 2026 the U.S. Food and Drug Administration implemented the Quality Management System Regulation (QMSR), representing the most significant update to its medical device quality system requirements in decades, The QMSR now aligns with the internationally recognised standard, ISO 13485 Medical Devices – Quality Management Systems, ISO 13485 is already required in many jurisdictions and forms the basis of the Medical Device Single Audit Program (MDSAP), in which the FDA participates alongside other regulators. While certain FDA-specific requirements, including reporting obligations, remain distinct, the overall structure is now far more closely aligned with global practice.
The move towards next generation propellants is not driven by regulation alone, public pressure on environmental issues is a large factor. As other industries phase down legacy HFCs, manufacturing volumes decline, supply tightens and costs increase. Even where policy momentum varies, commercial dynamics continue to reinforce the direction of travel.
As such, propellant strategy now requires a comprehensive view. Long-term supply security, cost trajectory, lifecycle planning and regulatory alignment must be assessed together. Ten years after Kigali, the central question is no longer whether change is coming, but how effectively organisations can position themselves to manage it.
One of the more complex aspects of the transition lies in established or niche products.
Some inhalation products have served defined patient populations for decades. Reformulating them with alternative propellants requires substantial technical and clinical investment. As transition timelines approach, companies may face difficult lifecycle decisions.
Early regulatory engagement is therefore essential. Understanding evidentiary expectations and assessing commercial viability well in advance of deadlines helps mitigate risk. Strategic portfolio planning will be critical to ensuring continuity for patients while maintaining compliance.
Beyond the canister: Supply chain and materials scrutiny
Sustainability regulation is increasingly extending beyond formulation into the wider supply chain. The EU Deforestation Regulation exemplifies this shift. It aims to prevent products being placed on the EU market that contribute to deforestation. In practice, this will require traceability across multiple tiers of suppliers.
For inhalation devices, materials such as palm-derived components or wood-based inputs may fall within scope. Gathering robust data across complex supply chains can be challenging, and transparency maturity varies significantly.
At the same time, scrutiny of per- and polyfluoroalkyl substances (PFAS) is intensifying. Regulatory approaches differ across jurisdictions, and public pressure is influencing supplier behaviour. Some manufacturers are choosing to exit PFAS-related markets entirely, creating potential supply continuity risks.
For inhaled product manufacturing companies, the challenge is twofold: maintain compliance while protecting supply. Regulatory foresight allows early identification of vulnerable materials and proactive planning, rather than reactive substitution under time pressure.
Balancing plastics policy and patient safety
Along with regulations, policies continue to play an important role in guiding drug and device development and manufacturing. For example, the UK Plastic Packaging Tax incentivises the use of recycled plastic content. However, in medical devices, patient safety and performance consistency remain paramount.
Recycled polymers can introduce variability and potential contaminants. Demonstrating consistent safety and efficacy requires significant qualification. While bio-based or biodegradable materials may offer a longer-term sustainable pathway, they too must meet stringent mechanical and regulatory standards, including deforestation as biobased polymers are manufactured from agro-materials
Regulatory intelligence as a competitive advantage
In this environment, regulatory intelligence is no longer optional.
At Bespak, horizon scanning is a structured and continuous activity. We monitor draft legislation, agency discussions and emerging industry trends. Regulatory impact assessments are conducted early and translated into practical guidance for our customers.
As the specialist inhalation contract development and manufacturing organisation (CDMO) working across multiple programmes and markets, we have broad visibility of regulatory expectations. We use this insight to inform development strategy, support scientific advice meetings and strengthen submission narratives. Preparedness is a commercial differentiator. Programmes aligned with regulatory direction move forward with greater certainty and fewer surprises.
Looking ahead
Over the next three to five years, sustainability will move from differentiator to baseline expectation. Carbon footprint, materials provenance and lifecycle impact will feature more prominently in regulatory and commercial discussions. Supply chain resilience will sit alongside compliance as a strategic priority. Climate disruption and geopolitical volatility underline the importance of robust sourcing strategies and early risk assessment.
The inhalation sector has navigated transformative change before. Today’s shift is broader in scope, touching propellants, materials and supply chains simultaneously. For manufacturers, success will depend on integrating regulatory foresight into every stage of development. At Bespak, we combine regulatory expertise with technical and manufacturing insight to help our customers navigate this complexity with confidence.
The green transition is not a single milestone, it is an ongoing evolution. By engaging early and thinking strategically, we can ensure innovation and compliance move forward together.
Speak to us to explore how we can support your oral and nasal inhalation programmes through the next phase of regulatory change.
