On the EMA Q&A on the Implementation of 3DP (Additive Manufacturing) Technology for Solid Oral Dosage Forms (EMA/CHMP/CVMP/QIG/GMP/QWP/55150/2026, 12 March 2026)
Prepared by: CurifyLabs Date: April 2026
CurifyLabs welcomes the publication of the European Medicines Agency (EMA) Questions & Answers document on the implementation of 3D printing (3DP) technology for solid oral dosage forms. The document is a meaningful step forward: it anchors 3DP squarely within the established pharmaceutical quality framework, gives regulators, manufacturers and inspectors a common language to discuss this emerging technology, and signals that 3DP is a legitimate and forward-looking option for patient-centric medicines.
Our high-level reading of the document is that it is well drafted and practical — but, importantly, that it does not fundamentally reinvent the quality or GMP expectations that already apply to conventional solid oral dosage forms. In essence, the EMA confirms what we have believed from the outset: 3DP is a manufacturing technology, and it must be designed, validated, controlled and operated to the same rigorous standards as any other pharmaceutical manufacturing process.
The document's main gap, from our perspective, is its limited treatment of pharmacy compounding. The Q&A is primarily framed around products with a marketing authorisation (and, to a lesser extent, investigational medicinal products), while pharmacy preparations are explicitly delegated to national legislation. This leaves a considerable amount of practical and regulatory nuance in the hands of pharmacies, hospitals, compounders and their technology suppliers — which is precisely where CurifyLabs focuses.
Against this backdrop, we believe the most important question for pharmacies, hospitals and health systems selecting a 3DP compounding solution is not whether the technology is novel, but whether the overall system — hardware, excipient bases (pharma inks), software and quality system — has been built to pharmaceutical standards from day one. This paper sets out our view of the EMA document, its implications for pharmacy compounding, and the criteria we believe customers should use when evaluating 3DP compounding platforms.
The EMA Q&A is structured around two core questions: which quality requirements are relevant to support 3DP in pharmaceutical manufacturing, and which GMP requirements apply. The answers draw heavily on the existing EU Quality and GMP architecture — ICH Q8(R2), Q9(R1), Q1D, Q6A, the EU GMP Guide (including Annexes 11, 15 and 22), the Guideline on Process Validation, Real Time Release Testing, and the 2025 Commission Implementing Regulations on GMP. In other words, the Q&A does not create a separate regulatory track for 3DP; it interprets and applies the existing one.
On the quality side, the document emphasises familiar themes: Quality by Design, identification of critical quality attributes, characterisation of raw materials, definition of critical process parameters, and validated control strategies — including the use of non-destructive in-process techniques such as NIR and Raman. On the GMP side, the emphasis is again on well-known expectations: qualified equipment, validated processes, qualified suppliers, controlled pharma ink cartridges/syringes, documented cleaning and maintenance, trained personnel, and rigorous computerised system and software validation.
Where the document does add specific value for 3DP is in areas such as: recognising pharma inks (and cartridges/syringes) as critical intermediate products that must be developed, stability-tested and controlled in their own right; calling out printer-specific CPPs (nozzle geometry, printing head/bed/chamber temperature, extrusion pressure, print speed, jetting frequency); acknowledging matrixing and bracketing for validating series of strengths from a single formulation; and explicitly framing 3DP as a non-standard manufacturing process (Annex II of the process validation guideline) — which has practical consequences for validation strategy and confirmatory batches when technology is transferred from supplier to end user.
Taken as a whole, however, the message is one of continuity rather than disruption. A pharmaceutical manufacturer that already operates a mature quality system — with robust supplier qualification, process validation, cleaning validation, computerised system validation, QRM and lifecycle management — will recognise nearly every expectation in this Q&A. The novelty lies in how these well-established principles are mapped onto 3DP equipment, pharma inks and digital design files, not in the principles themselves.
CurifyLabs considers the EMA Q&A a constructive and timely contribution. It sends three important signals to the market. First, regulators see 3DP as a credible pharmaceutical manufacturing technology, not an experimental curiosity. Second, 3DP must earn its place inside the existing quality and GMP framework rather than be granted a lighter-touch regime. Third, patient-centric benefits — paediatrics, geriatrics, polypharmacy patients, rare diseases — are explicitly recognised as a core rationale for the technology, which aligns closely with the unmet clinical needs our customers face every day.
At the same time, we want to be clear-eyed: most of what the document prescribes is not unique to 3DP. Equipment qualification, process validation, supplier qualification, stability studies, change control, CSV under Annex 11, cleaning validation, QRM under ICH Q9(R1) — these apply equally to tablet presses, capsule fillers and 3D printers. The operational demands on a manufacturer using 3DP at commercial scale are substantially the same as those on any other pharmaceutical manufacturer. Anyone expecting a simplified or exemption-based pathway for 3DP should read this Q&A carefully; there isn't one.
For us, this is a positive outcome. We have always maintained that the credibility of 3DP in medicines hinges on how seriously its proponents take the fundamentals. The EMA document reinforces that view.
The EMA Q&A is explicit about its scope: it addresses human and veterinary medicinal products covered by a marketing authorisation, and is also relevant for investigational medicinal products. Pharmacy preparations under Article 3 of Directive 2001/83/EC are pointed back to national legislation and the relevant National Competent Authorities. This is a legally correct position — compounding in the EU is governed at Member State level — but it leaves several important questions under-addressed for the community that arguably stands to benefit most from 3DP in the near term: pharmacies and hospitals producing patient-specific dosage forms.
A few nuances are worth emphasising. First, compounding pharmacies operate under a patchwork of national frameworks (PIC/S GPP, national GMP-like standards for hospital pharmacies, NF and Ph. Eur. compliance, etc.), with significantly different expectations for documentation, qualification of equipment and validation of processes. A 3DP platform deployed across multiple jurisdictions must therefore be designed to meet the strictest interpretation, not the lowest common denominator.
Second, batch sizes in compounding are small — often one patient, one dose — which makes the document's reference to non-destructive in-process monitoring (NIR, Raman, mass control, real-time rejection of non-conforming units) even more relevant for compounding than for commercial manufacturing. End-product testing of every unit is rarely feasible in a pharmacy setting; a robust, validated process with in-line controls is essential.
Third, the document's emphasis on qualified pharma inks, cartridge stability, thermal cycling, in-use studies, re-use limits and homogeneity of suspensions translates directly to a pharmacy environment. A compounding pharmacy is not in a position to develop and qualify its own excipient bases from raw polymers; it has to be able to rely on a qualified supplier operating to pharmaceutical standards. The EMA document implicitly assumes this supply chain exists; the question for a pharmacy is whether, in practice, its chosen technology provider can actually deliver it.
Fourth, the Q&A is largely silent on the specific operational realities of hospital and pharmacy compounding: staff who are pharmacists rather than industrial operators, integration with patient-specific prescriptions, documentation flows into the pharmacy's own QMS, and the cybersecurity and data-integrity posture required when digital design files and patient data meet on the same platform. National frameworks will address some of this; technology providers must address the rest.
In short, the EMA document sets the right direction of travel, but pharmacy compounding customers cannot assume their obligations — or their suppliers' obligations — end where the document's formal scope ends. If anything, the bar for a credible pharmacy-compounding 3DP platform is higher, because fewer elements can be left to the end user to handle.
CurifyLabs has built its 3DP compounding system from the ground up with one non-negotiable principle: quality is the foundation, not a trade-off. Speed, flexibility and patient-centric design are essential to our value — but we believe they are only meaningful when they sit on top of a pharmaceutical-grade quality architecture, rather than competing with it. This approach is reflected across three pillars of our solution — the device and the quality system behind it, the excipient bases, and the software.
Our CurifyLabs platform has been designed, developed and is manufactured under a rigorous ISO 13485-compliant quality management system. Our QMS is certified, audited and lived — not a binder on a shelf. Every aspect of the device lifecycle, from design controls and risk management (ISO 14971) to production, installation and post-market surveillance, is traceable and documented. This gives our customers a clear foundation of evidence when qualifying the equipment on their side, as required by EU GMP Chapter 3 and Annex 15 — and now reinforced by the EMA Q&A and the Commission Implementing Regulation 2025/2091.
In practical terms, this means our customers receive structured qualification documentation (URS, DQ, IQ, OQ support, maintenance and calibration plans aligned with our recommendations) rather than a black-box machine they have to reverse-engineer into their own QMS. It also means that when the EMA document highlights the importance of equipment knowledge transfer between the 3D printer manufacturer and the end user, we can meet that expectation substantively, not just contractually.
The EMA Q&A is emphatic about the role of pharma inks — the cartridges and syringes containing the formulation to be printed — as critical intermediate materials. Their selection, qualification, stability and supplier controls are all called out in detail. Our answer to this is simple: our excipient bases are GMP-manufactured at qualified suppliers, with the supporting documentation, specifications, stability data and controls that a regulated pharmacy or hospital needs to incorporate them into its own processes.
This design choice solves one of the hardest problems for any pharmacy considering 3DP: how to ensure that the material going into the printer has the properties (rheology, extrudability, thermal stability, microbiological quality, excipient compatibility) required for the process to consistently produce dosage forms of the desired quality. Rather than asking our customers to characterise raw polymers or optimise formulations from scratch, we deliver qualified, GMP-manufactured excipient bases that are designed to work with our hardware and software as a validated system.
The EMA Q&A underlines that a 3D printer is a fully computer-driven system, and that compatibility between printer and software is critical to final product quality. It calls for computerised system validation in line with Annex 11, covering data integrity, 3D model design, file transfer qualification, software validation and update management — and, where applicable, AI-specific considerations under Annex 22.
Our software has been developed to meet both GxP expectations (Annex 11, ALCOA+ data integrity, electronic records and signatures, audit trails, role-based access, change and release management) and modern information-security standards. We operate to SOC 2 controls to ensure that confidentiality, integrity and availability of patient and product data are continuously monitored and independently attested. For pharmacy customers, this matters because the software is where patient prescriptions, digital design files, process parameters and production records come together. Anything less than a GMP- and SOC 2-compliant posture is, in our view, incompatible with responsible 3DP compounding.
The publication of the EMA Q&A is a good moment for any pharmacy, hospital, compounder or health system considering 3DP to step back and re-examine the fundamentals of any technology they are evaluating. Performance characteristics such as print speed, throughput and dosage-form design matter — they translate directly into clinical and operational value — but they only mean something if the quality architecture behind the product is solid. We therefore believe the right questions to ask a potential supplier start with that architecture, and then move on to performance. Based on the EMA expectations and our own experience, we suggest the following.
Our view is straightforward: if a supplier cannot answer these questions clearly and with evidence, they are not yet ready to partner with a regulated healthcare organisation on 3DP — no matter how impressive their demo looks.
A few further reflections are worth offering. First, the EMA document notes explicitly that it may evolve as the technology matures. We encourage the Agency, along with the EMA Quality Innovation Group (QIG) and national authorities, to continue engaging with industry and with compounding stakeholders, and to consider future iterations or companion documents that directly address pharmacy preparations — ideally in coordination with Member State authorities and PIC/S.
Second, the document's references to Annex 22 and the EMA Reflection paper on AI in the medicinal product lifecycle are a useful signal that regulators anticipate AI and machine-learning components appearing in 3DP ecosystems. Suppliers should be thinking now about how any AI-assisted functionality — formulation recommendation, anomaly detection, print-quality prediction — will be validated, monitored and governed over time.
Third, we believe the single most important cultural message of the document is the mainstreaming of 3DP. It is no longer framed as an exotic technology requiring bespoke rules; it is framed as pharmaceutical manufacturing that happens to use additive deposition. Any organisation adopting it should do so with the same seriousness it would bring to any other GMP activity — and choose partners who demonstrably do the same.
Finally, CurifyLabs is committed to supporting its customers, regulators and the wider pharmaceutical community in the responsible adoption of 3DP for compounding. We welcome the EMA Q&A as a foundation to build on, and we stand ready to engage with stakeholders on how to close the remaining gaps — particularly in pharmacy compounding — through a combination of technology, qualified materials, compliant software and transparent, quality-led partnership.
CurifyLabs For questions about this position paper or about how CurifyLabs approaches quality in 3DP compounding, please contact your CurifyLabs representative or reach out via www.curifylabs.com or contact niklas.sandler@curifylabs.com directly