What Pharmaceutical Companies Need to Know as PPWR Arrives
Pharmaceutical Packaging in Transition
On 12 August 2026, the EU's Packaging and Packaging Waste Regulation (PPWR) formally applies across all 27 member states. It is the most significant overhaul of European packaging law in three decades, and while pharmaceutical packaging carries certain exemptions, no one in the sector should mistake that for a free pass. For pharmaceutical companies and their leadership teams, PPWR is not simply a compliance milestone to tick off — it is the moment two very different bodies of work, moving at two very different speeds, come into sharp focus at once. And it is not a problem that sits neatly inside one department: procurement, regulatory affairs, quality assurance and operations will all have a stake in how it is resolved.
Two problems wearing one deadline
The first is new product development. Any team specifying packaging today already knows the general direction of travel: design-for-recycling principles, a move toward mono-material structures, harmonised EU sorting labels expected from 2028, and recyclability grading with minimum recycled-content requirements from 2030. Products entering development now can have the opportunity to be built around these expectations from the outset — at the drawing board, in supplier selection, in material choice — rather than retrofitted later. That is, in principle, the easier problem. It is forward-looking, and the cost of doing it right is lowest right at the start. The importance of having procurement, regulatory affairs, quality and the supplier base involved at the early stages will support this challenge.
The second problem is medicine already on the market. Every pack, insert, blister format and closure combination that has been through validation, stability testing and regulatory approval represents years of accumulated technical and regulatory investment. Changing any element of that — a material, a laminate structure, a supplier — is not a quick swap. Validation and stability testing alone can take considerable time, and regulatory filing and supply continuity implications need to be factored in. Multiply that across a full portfolio, much of it comprising older, high-volume, low-margin products, and you have a genuinely large and slow-moving body of work that does not fit neatly against a single deadline.
The honest question for most organisations right now is not “are we PPWR ready?” It is: do we actually know which of our products are being designed with this in mind from the outset, and which are sitting in a legacy pile that someone still must prioritise, cost, schedule and justify? That portfolio-level visibility — not the regulation itself — is where the real work sits over the next several years, and it is a cross-functional effort rather than a single team's to solve alone.
Why blister packs are not going anywhere
It would be easy to read the direction of travel in drug delivery — the well-documented rise of pre-filled syringes and wearable injector devices — and assume traditional blister packaging is simply on its way out. That reading misses most of the picture.
Blister packaging remains the backbone of oral solid dose medicines, and oral solid dose remains, by volume, the largest category of pharmaceutical product on the market. It is cost-effective at scale, offers strong barrier protection for shelf stability, supports dose-by-dose patient adherence, and is manufactured on infrastructure that already exists across thousands of production lines globally. None of that changes because a newer delivery format is growing quickly in a different therapeutic category.
What is changing is the material composition of blister packs themselves. Design-for-recycling principles under PPWR are pushing development toward mono-material blister structures — PP, PET or paper-based systems that replace the multilayer PVC/foil laminates that have dominated for decades — precisely because those laminates are difficult to recycle. This is an evolution of the format, not its replacement. For pharmaceutical leaders, it means blister packaging deserves just as much attention in a sustainability strategy as the newer delivery formats getting more of the headlines — arguably more, given the volumes involved.
Why pre-filled syringes and wearables are growing regardless
At the same time, the shift toward pre-filled syringes and wearable injector devices is real and largely independent of packaging regulation. It is being driven by the growth of biologic and biosimilar therapies that require cold-chain integrity and precise dosing, by safety-engineered device requirements for needlestick injury prevention, and by a broader move toward home administration and decentralised care. These are clinical and commercial drivers, not sustainability ones — and that distinction matters for how pharmaceutical companies think about them, particularly as regulatory affairs and quality teams weigh in on device classification, combination-product requirements and safety data.
It is worth being candid here: pre-filled and wearable delivery formats are not automatically the more sustainable choice. The current lifecycle of many single-use injection devices is more resource-intensive than the multi-dose or reusable formats they sometimes replace, and disposable syringe formats can increase overall plastic waste relative to more traditional alternatives. Sustainability strategy in this space is not a simple story of “new format good, old format bad.” It is a genuine trade-off between clinical benefit, patient convenience, supply resilience and environmental impact — and it needs to be treated as one.
What this means in practice for pharmaceutical companies
Three things are worth prioritising now, ahead of the technical criteria and grading frameworks that will land progressively through 2028 and 2030. None of them sit within a single function — they need procurement, regulatory affairs, quality assurance and operations working from the same picture.
First, build a portfolio-level classification: which products are in active development and can be designed around PPWR expectations from the start, and which are legacy products that will require a planned, resourced revalidation pathway. Treating these as the same workstream, with the same timeline, sets unrealistic expectations for both.
Second, engage packaging and material suppliers on lifecycle assessment data now. Many organisations already collect this for CSRD (Corporate Sustainability Reporting Directive) reporting, and that data can largely be reused for PPWR recyclability assessments — a single source of truth that pays off twice rather than duplicating effort.
Third, resist a one-format narrative. The sustainability conversation in pharmaceutical packaging is not “blister versus syringe” or “old versus new.” It is a genuinely multi-variable decision involving cost, supply security, patient safety, clinical requirement and environmental impact, and it needs input from across the business — procurement, regulatory affairs, quality and operations each hold a piece of the picture that the others don't.
PPWR's arrival on 12 August 2026 is a useful forcing function, but the underlying work — building visibility across an entire product portfolio and making evidence-based trade-offs rather than following format trends — was already a shared responsibility across the business. The deadline simply makes it harder to defer.
Let's talk
If your organisation is starting to map where PPWR intersects with your product portfolio — or you'd value a second opinion on how procurement, regulatory affairs, quality and operations should be sequencing this work — we'd welcome the conversation. Whether that's a portfolio-level classification review or help sequencing PPWR alongside your existing procurement priorities, we can help you build a plan instead of reacting to the deadline.Visit collaborative-sourcing.com to find out more about how we help pharmaceutical companies build resilient, sustainable supply chains, or connect with us on LinkedIn to keep the conversation going.
About the Author
Graham Phillipson is Co-Founder of Collaborative Sourcing, a procurement consultancy dedicated to the life science industries. His background spans packaging, medical devices, and sustainability across the pharmaceutical and biotech sectors, and he works with clients to build resilient, evidence-based procurement strategies — from material selection through to full supplier lifecycle management.