3D printing of oral solid dosage forms

Date

October 28, 2026

Category

EU Regulations

Description

On 12 March 2026 the EMA issued guidance titled “Questions & Answers on the Implementation of 3DP Technology (Additive Manufacturing Technology) for Solid Oral Dosage Forms” see https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-3dp-technology-additive-manufacturing-technology-solid-oral-dosage-forms_en.pdf.

The central message in this guidance is that 3D-printed medicines are expected to meet the same pharmaceutical quality and GMP standards as conventionally manufactured medicines, while addressing additional risks associated with:

1. Digital design and file control.
2. Printer qualification and software validation.
3. Pharma ink/cartridge stability.
4. Print-specific CPPs and PAT controls.
5. Highly flexible manufacturing of personalised strengths and dosage forms.

The guideline strongly promotes a QbD, risk-based, and data-driven control strategy, with extensive process understanding and real-time monitoring considered particularly important for 3DP manufacturing.

In October 2026 the European Pharmacopoeia Commission announced the setting up of 3D-Printed Medicinal Products Working Party (3DP WP) to explore how best to provide quality standards for 3D-printed medicines in the European Pharmacopoeia (Ph Eur).