Brazil City March 26, 2026
Overview
The European Medicines Agency (EMA) has issued guidance addressing Good Manufacturing Practice (GMP) considerations for the use of additive manufacturing, also known as 3D printing (3DP), in the production of solid oral dosage forms. This guidance represents a significant step toward integrating innovative manufacturing technologies into the pharmaceutical regulatory framework while ensuring product quality, safety, and efficacy.
Introduction
Additive manufacturing, commonly referred to as 3D printing (3DP), is transforming pharmaceutical development by enabling the production of customized dosage forms tailored to individual patient needs. Through the use of digital 3D models, such as computer-aided design (CAD) files, medicines can be manufactured layer by layer, offering unprecedented flexibility in drug design.
Recognizing the growing adoption of this technology, the EMA has provided guidance to ensure that manufacturers comply with GMP requirements while leveraging the benefits of 3DP. This regulatory framework is essential to balance innovation with patient safety and product quality.
Development Understanding Additive Manufacturing in Pharmaceuticals
3D printing encompasses a range of technologies used to create solid structures through the sequential layering of materials. In pharmaceuticals, this allows the development of dosage forms with varying strengths, shapes, colors, flavors, and even combinations of active substances.
This flexibility supports patient-centric approaches, particularly benefiting populations such as pediatric and geriatric patients, individuals with rare diseases, and those undergoing complex multi-drug therapies.
Advantages of 3D Printing Technology
The EMA highlights several advantages associated with additive manufacturing, including:
- Rapid and flexible manufacturing processes
- Reduced production steps and increased automation
- Capability for small-scale, on-demand production
- Enhanced personalization of medicinal products
Recent applications in Europe demonstrate the potential of this technology. For example, hospitals have developed chewable dexamethasone tablets for pediatric oncology patients and hydrocortisone formulations tailored for children with adrenal insufficiency.
Quality Considerations and Critical Parameters
The EMA emphasizes that several factors may impact product and process performance, depending on the technology and equipment used:
- Rheological properties and printability of formulations
- Physical state of the active substance (crystalline or amorphous)
- Particle size of raw materials
- Compatibility between active substances and excipients
Manufacturers must also assess how the 3DP process affects the final product’s characteristics, including dissolution and pharmacokinetic behavior.
Critical Components: Cartridges and Syringes
Cartridges and syringes are considered critical elements in the manufacturing process. The stability of the formulation within these components must be evaluated to ensure product integrity.
For reusable systems, manufacturers must assess physicochemical and microbiological stability before and after opening, considering real-use conditions such as storage and frequency of use.
Process Validation and Control Strategy
The guidance reinforces the importance of process validation aligned with existing EMA requirements. Manufacturers must:
- Validate 3DP processes in accordance with GMP principles
- Perform risk assessments when implementing technical changes
- Conduct revalidation when necessary
When technology is transferred from equipment suppliers to end users, manufacturers must demonstrate process robustness and reproducibility through confirmatory batches.
Additionally, a comprehensive control strategy must be implemented, defining specifications for both intermediate materials (e.g., pharmaceutical inks) and finished products, in compliance with EMA guidelines and European Pharmacopoeia standards.
GMP Compliance Requirements
The EMA specifies that the following activities must comply with GMP requirements:
- Equipment design and qualification (including software)
- Manufacturing of cartridges and intermediates
- Printing process execution
- Quality control testing
- Batch certification and release
Conclusion
The EMA’s guidance on additive manufacturing marks a pivotal advancement in the integration of innovative technologies into pharmaceutical production. While 3D printing offers significant opportunities for personalized medicine and operational efficiency, it also introduces new regulatory and technical challenges.
By establishing clear GMP expectations, the EMA ensures that manufacturers can adopt this technology responsibly, maintaining high standards of quality, safety, and efficacy. Companies that proactively adapt to these requirements will be better positioned to lead in the future of pharmaceutical innovation.
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References
Bibliographic References
•EUROPEAN MEDICINES AGENCY (EMA). Guidance on GMP considerations for additive manufacturing (3D printing) of solid oral dosage forms. 2026.
•INTERNATIONAL JOURNAL OF PHARMACEUTICS. Applications of 3D printing in hospital settings. 2025.
•EUROPEAN PHARMACOPOEIA (Ph. Eur.). General requirements for medicinal products.
•ICH (International Council for Harmonization). Guidelines on Pharmaceutical Quality Systems and Process Validation.
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