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EMA issues Q&A guideline on additive manufacturing

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EMA issues Q&A guideline on additive manufacturing

The European Medicines Agency (EMA) has published a new Q&A guideline focused on GMP and quality aspects related to 3D printing in pharmaceutical manufacturing. Released in mid-March, the document applies to human and veterinary medicines as well as investigational products, highlighting the growing role of additive manufacturing technologies in the healthcare sector.

According to EMA, 3D printing — also referred to as additive manufacturing — is an umbrella term covering different techniques used to create solid structures through the sequential deposition of layers of suitable materials. The technology is increasingly being explored for the production of personalised pharmaceutical dosage forms.

Focus on quality-by-design and process validation

Among the main advantages of additive manufacturing, the guideline highlights the possibility of tailoring dosages, combining multiple active ingredients and customising the shape and colour of tablets. These features could improve usability and treatment adherence, particularly for paediatric and geriatric patients.

The EMA document adopts a quality-by-design approach across the entire production cycle. It discusses the selection of the most appropriate printing technology according to the characteristics of the active pharmaceutical ingredient (API), including solubility, degradation profile and biopharmaceutical classification.

The guideline also examines all factors that may affect the final quality of the medicinal product, such as rheological properties, physical state of the API, particle size, compatibility with excipients and stability, including aspects linked to printing temperatures. Additional attention is given to the properties of the so-called “pharmaceutical ink” and to process validation requirements.

Trump’s tariffs after Section 232 probe

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Trump’s tariffs after Section 232 probe

Following the conclusion of the Section 232 investigation launched in August 2025, US President Donald Trump announced on 2 April 2026 a sweeping new tariff policy targeting pharmaceutical imports. The measure introduces a 100% tariff on all imported patented medicines and their related ingredients, marking a significant shift in US trade and industrial strategy in the healthcare sector.

Phased rollout and differentiated rates

The implementation timeline varies by company size. Large pharmaceutical firms will be subject to the new tariffs within 120 days, while smaller companies will have a longer adjustment window of 180 days.

However, the policy includes differentiated treatment for key allied markets. Pharmaceutical products imported from the European Union, Japan, South Korea, Switzerland, and Liechtenstein will be subject to a reduced tariff rate of 15%. Imports from the United Kingdom will face an even lower rate, although the exact percentage has not been specified.

Exemptions and incentives for onshoring

The framework also introduces incentives tied to pricing and manufacturing commitments. Companies that have entered into Most Favoured Nation (MFN) pricing agreements with the Department of Health and Human Services (HHS), and have simultaneously signed onshoring agreements with the Department of Commerce, will benefit from a full exemption from tariffs until 20 January 2029. By contrast, companies that have only signed onshoring agreements will face a reduced tariff rate of 20%.

Notably, certain categories of medicines are currently excluded from the new duties. Generic and biosimilar drugs, along with their associated ingredients, remain fully exempt, although this provision is set to be reviewed in one year. Additional exemptions are предусмотрed for orphan drugs, veterinary medicines, and other specialised medicinal products.

The new tariff regime underscores Washington’s dual objective of strengthening domestic pharmaceutical manufacturing capacity while maintaining strategic trade relationships with selected partners.

Gene and cell therapies, market trends for Q4 2025

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Gene and cell therapies, market trends for Q4 2025

The latest figures on the gene and cell therapy market released by the Alliance for Regenerative Medicine for the fourth quarter of 2025 show a clear lead for the United States over Europe, both in the number of clinical trials (916 vs 337) and in total investments ($2.5 billion vs $0.6 billion), despite a nearly identical number of developers (703 vs 685).

On the regulatory front, the new “plausible mechanism pathway” announced by the FDA at the end of last year is designed to accelerate access to personalized gene editing therapies and other treatments targeting unmet medical needs. Also in the United States, Baby KJ became the first child to receive an in vivo gene editing treatment for the ultra-rare CPS1 deficiency—a condition caused by the lack of the carbamoyl phosphate synthetase 1 enzyme, leading to toxic ammonia accumulation in the body. The CRISPR-based therapy was developed in just six months from diagnosis, with FDA authorization granted in only one week.

In Europe, meanwhile, the publication of the Biotech Act by the European Commission on December 16, 2025, is being seen as a turning point for the biotech medicines sector. The initiative combines financial incentives with regulatory improvements aimed at supporting the development of gene and cell therapies.

European pipelines lag behind

The report also highlights a robust U.S. pipeline, with at least twenty gene and cell therapy products already approved (three in 2026) or nearing regulatory submission.

By contrast, Europe’s clinical pipeline remains significantly smaller, with only five products approaching or having reached approval in 2026. Among them is the gene therapy developed by Fondazione Telethon for Wiskott-Aldrich syndrome, approved by the European Commission on January 16, 2026. The therapy had also received FDA approval in December 2025 and marks a milestone as the first case worldwide of a gene therapy for a rare genetic disease fully developed by a non-profit organization. Two additional approvals are expected in Europe this year, involving a cell therapy for metastatic melanoma and a gene therapy for retinitis pigmentosa.

On the corporate front, the quarter was marked by Bristol Myers Squibb’s $1.5 billion acquisition of Orbital Therapeutics, alongside several new strategic partnerships. Notably, Italy’s Chiesi has entered into a collaboration with Arbor Biotechnologies focused on genome editing for the treatment of primary hyperoxaluria type 1, with an upfront commitment of $115 million from Chiesi.

EMA strengthens stakeholder dialogue across the medicines lifecycle

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EMA strengthens stakeholder dialogue across the medicines lifecycle

The latest report on EMA’s stakeholder engagement activities for 2024–2025 highlights an intensification of dialogue and collaboration aimed at integrating external contributions into both the evaluation and safety monitoring of medicines. The Agency confirms a structured and increasingly inclusive approach, designed to ensure that multiple perspectives are reflected throughout regulatory processes.

At the core of this strategy is a multi-stakeholder model that continues to evolve into a dynamic platform for exchange. Within this framework, patient-centricity has consolidated its role as a guiding principle, consistently considered across all phases of a medicinal product’s lifecycle—from development to post-market surveillance.

Growing participation and structured collaboration

One of the most tangible signals of this strengthened engagement is the increase in participation within EMA’s key working groups. Representatives from patient and consumer associations involved in the Patients’ and Consumers’ Working Party rose from 22 to 25 member organisations, reflecting a broader inclusion of patient voices. A similar upward trend was observed in the Healthcare Professionals’ Working Party (HCPWP), confirming the Agency’s effort to expand the contribution of healthcare professionals in regulatory discussions.

Engagement also extended to the academic and research community. Independent and not-for-profit research was supported through dedicated dialogue channels such as Academia Briefing Meetings (ABMs) and Innovation Task Force (ITF) meetings. These initiatives were complemented by concrete support measures, including fee reductions for scientific advice, the qualification of novel methodologies, and procedural assistance—tools aimed at fostering innovation while maintaining regulatory rigor.

Industry engagement and regulatory alignment

Parallel to this, EMA maintained regular exchanges with industrial stakeholders. Interactions took place both within the Industry Standing Group (ISG) and through bilateral meetings with individual organisations. These discussions focused primarily on the implementation of new legislative requirements, as well as on assessing the broader impact of cross-sectoral regulations, an increasingly relevant aspect in a complex and interconnected regulatory landscape.

Overall, the report outlines a stakeholder engagement model that is becoming more structured, participatory and aligned with the evolving needs of the European healthcare ecosystem.

ECHA’s proposed PFAS restrictions

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ECHA’s proposed PFAS restrictions

In March 2026, the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) of the European Chemicals Agency (ECHA) launched a public consultation on their opinions regarding a potential EU-wide restriction on PFAS. The proposed measure would limit the manufacture, placing on the market, and use of these substances, while allowing for specific derogations. Stakeholders can submit comments until 25 May 2026.

Growing risks for human health and the environment

In its final opinion, RAC highlights that PFAS pose increasing risks to both human health and the environment due to their high persistence. According to the Committee, existing regulatory measures are not sufficient to effectively control emissions, making coordinated EU-level action necessary. Where derogations are granted, RAC recommends a set of accompanying measures, including:

  • site-specific PFAS management plans for manufacturers and industrial users;
  • clear consumer labelling;
  • guidance on safe use and disposal.

SEAC’s draft opinion stresses that PFAS are widely used across multiple industrial applications in Europe, reinforcing the need for a harmonised EU approach to prevent internal market distortions. The Committee suggests that derogations should be limited to uses where no viable alternatives are currently available, alongside risk management measures to minimise emissions.

EFPIA raises concerns over pharmaceutical impact

The European Federation of Pharmaceutical Industries and Associations (EFPIA) responded to the committees’ opinions by highlighting the absence of explicit derogations for the pharmaceutical sector. According to EFPIA, “the absence of clear and durable derogations for medicines would compromise patient access to critical treatments and drive manufacturing out of Europe.”

The organisation notes that PFAS materials are essential in several pharmaceutical manufacturing processes, including the production of active substances and delivery devices. Moreover, replacing PFAS components is not straightforward, as it would require extensive R&D efforts as well as legal and regulatory approvals.

IFPMA’s position on AI in pharmaceutical manufacturing

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IFPMA’s position on AI in pharmaceutical manufacturing

Artificial Intelligence (AI) and Machine Learning (ML) are playing an increasingly central role in pharmaceutical manufacturing and control. A position paper published by IFPMA in March 2026 outlines both the opportunities and the challenges associated with their adoption across the sector.

Enhancing efficiency and enabling new applications

According to the document, AI has the potential to accelerate decision-making processes and enhance operational efficiency, ultimately leading to more robust manufacturing processes and shorter cycle times. By automating repetitive tasks with higher accuracy, AI can also deliver significant benefits in terms of data integrity and analytical capabilities.

Several real-world applications are already emerging, including predictive and control models such as digital twins of manufacturing processes. In parallel, generative AI is being used for text-related activities, for example in the preparation of regulatory documentation.

Regulatory alignment and the need for a common framework

From a regulatory perspective, a risk-based approach to the implementation and updating of AI and ML systems has been adopted by many international authorities. The paper highlights a strong alignment between the requirements set by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), suggesting a growing convergence at the global level.

IFPMA also points to the opportunity to develop a sector-specific AI risk framework for the pharmaceutical industry, alongside the promotion of global harmonisation of regulatory standards to support wider adoption in manufacturing.

Addressing risks and ensuring sustainable adoption

The document highlights several AI-specific risks that require careful management, including automation bias, the potential erosion of human oversight, challenges related to explainability and interpretability, autonomous learning, data quality, and lifecycle maintenance.

To address these challenges, the position paper proposes a set of actions aimed at enabling safe, effective and scalable implementation of AI and ML technologies across the pharmaceutical sector.

The role of quantum mechanics in drug discovery

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The role of quantum mechanics in drug discovery 
Edited by Matteo Iafrate - Pharmaceutical Analytical Chemist

Quantum mechanics allows us to obtain very accurate results in the study of molecules. Over the years, numerous computational methods have been developed that are capable of studying the system under examination with different approaches, always rigorously based on quantum theories. Quantum mechanics attempts to interpret, with excellent results, through statistical probability, the behavior of matter and its energy at the atomic and subatomic level, differentiating itself from classical mechanics, which applies to macroscopic systems. It is important to underline that classical mechanics fails at the molecular level because several properties such as electron delocalization and chemical bonding are strictly linked to quantum effects. Furthermore, quantum mechanical methods offer high accuracy for small systems, while classical methods can handle large systems with reduced accuracy.

Theoretical Foundations

Some of the main theoretical aspects of quantum theory concern wave-particle duality, the quantization of energy, wave function and probability, the superposition principle, the Heisenberg uncertainty principle, and entanglement. The study of time evolution, which describes how the wave function changes over time, with a probabilistic approach, is described by the Schrödinger equation:

Where Ĥ represents the Hamiltonian operator (including kinetic and potential energy terms), and ψ the wave function

In scientific literature, the use of computational methods that make use of quantum mechanics is increasingly present. Among the most widely used are: density functional theory (DFT), Hartree-Fock (HF), quantum mechanics/molecular mechanics (QM/MM), and fragment molecular orbitals (FMO).

Methods and applications

These techniques are based on quantum mechanics, but operate and describe the system under study differently. For example, density functional theory (DFT) is based on the electron density, while the Hartree-Fock method (HF) is based on the wave function. Quantum mechanics/molecular mechanics (QM/MM) is a hybrid method, aiming to combine the accuracy of quantum mechanics  for the molecular regions under study with the efficiency of molecular mechanics (MM). The fragmented molecular orbital method (FMO) splits a large molecule into smaller fragments, with the aim of treating each fragment quantum mechanically and taking into account their interactions.

Many of the results obtained, with the integration of quantum computing, aim to accelerate the drug development cycle and improve workflows, model interactions between small molecules and macromolecules, understand the functioning of enzymes based on electronic effects, model protein-ligand interactions and much more. The increase in computational performance and the excellent results obtained identify the quantum mechanical approach as very promising in drug discovery. In the coming years, computational drug discovery combined with quantum mechanics is expected to become increasingly common.

References

  • Sarfaraz K. Niazi. Quantum Mechanics in Drug Discovery: A Comprehensive Review of Methods, Applications, and Future Directions, Int. J. Mol. Sci., 2025.
  • Yidong Zhou, Jintai Chen, Jinglei Cheng, Xu Cao, Yuanyuan Zhang, Gopal Karemore, Marinka Zitnik, Frederic T. Chong, Junyu Liu, Tianfan Fu, Zhiding Liang. Quantum-machine-assisted drug discovery, npj Drug Discovery, 2026.

Be Ready, the new partnership for pandemic preparedness

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Be Ready, the new partnership for pandemic preparedness

The new partnership, Be Ready, launched by the European Commission in February 2026, is designed to significantly strengthen and expand research activities dedicated to pandemic preparedness across Europe. Under the initiative, a total budget of €120 million from the Horizon Europe programme will be made available to support projects focusing on emerging and re-emerging pathogens, with the goal of accelerating the development of advanced diagnostics, innovative treatments and next-generation vaccines. The partnership is coordinated by the French research authority ANRS-MIE and brings together a broad network of 81 organisations from 27 countries, reflecting a strong commitment to international collaboration.

Beyond funding, Be Ready will work to align national research priorities among participating countries, fostering greater strategic coherence and reducing fragmentation. It will also enhance coordination in pandemic preparedness research through the definition of a shared strategic and research innovation agenda, enabling a more structured and forward-looking approach.

Joint transnational calls will play a key role in supporting multinational research projects, promoting coordinated funding mechanisms among national and European funders. At the same time, all core components of the initiative will be fully integrated into the wider research ecosystem, ensuring that Be Ready remains active and effective not only during health emergencies but also in the periods between epidemics, strengthening long-term resilience.

Reactions to the EU Court of Justice’s rejection of the annulment of the UWWTD

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Reactions to the EU Court of Justice’s rejection of the annulment of the UWWTD

The European General Court has dismissed EFPIA’s legal action (Case T-158/25) seeking the annulment of the Urban Wastewater Treatment Directive (UWWTD). The ruling, however, is based solely on procedural grounds and does not address the substance of the Directive, leaving the underlying legal questions unresolved.

Court dismisses EFPIA case on procedural grounds

In its decision, the Court concluded that EFPIA had not demonstrated that it was individually concerned by the provisions of the Directive it challenged. This requirement, together with being directly concerned, represents one of the cumulative legal conditions that must be met in order to establish legal standing before the EU General Court. Because these conditions were not considered satisfied, the Court declared the action inadmissible. As a result, the ruling does not examine the merits of EFPIA’s arguments nor the broader legal validity of the Urban Wastewater Treatment Directive.

Following the decision, EFPIA reaffirmed its commitment to ensuring that EU legislation is implemented in full respect of fundamental principles of EU law. Among these, the association highlighted the importance of the “polluter pays” principle, as well as the principles of non-discrimination and proportionality. Since the Court did not address the substance of the case, these legal issues remain open and could still be examined in other proceedings.

Implications for AESGP’s intervention request

The dismissal of EFPIA’s action also resulted in the non-adjudication of AESGP’s request to intervene in the case. AESGP, which represents the self-care industry, had sought to participate in the proceedings to support the arguments raised. According to the association, the key legal questions surrounding proportionality, non-discrimination and the polluter-pays principle should instead be assessed in other ongoing cases, particularly Poland’s legal challenge against the UWWTD (Case C-193/25).

Legal scrutiny of the Directive is continuing through other channels. In parallel with EFPIA’s action, the Irish Pharmaceutical Healthcare Association (IPHA) is advancing a case before the High Court in Ireland, seeking a referral to the Court of Justice of the European Union (CJEU) for a preliminary ruling on the validity of the Directive. The General Court’s order also clarifies an important procedural point: when national courts have doubts about the validity of an EU Directive, they should refer the matter to the CJEU.

For this reason, although EFPIA’s action has been dismissed, the broader legal debate surrounding the Urban Wastewater Treatment Directive is likely to continue in both national courts and EU-level proceedings.

Concept paper on the revision of Annex 15

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Concept paper on the revision of Annex 15

As agreed during the 115th meeting of EMA’s GMP/GDP Inspectors Working Group (GMDP IWG) in September 2024, the European Medicines Agency has launched a targeted revision of Annex 15 of the Good Manufacturing Practices (GMPs). The consultation period on the Concept Paper, jointly published by EMA and PIC/S in February 2026, will remain open until 9 April 2026. This initial phase will be followed by the publication of a revised draft guideline and a second round of consultation, with the final text expected to be published by the end of 2026.

The initiative to revise Annex 15 stems from lessons learned since 2020 regarding the presence of N-nitrosamine impurities in medicines containing sartans as active ingredients. The report published on the case highlighted, among other aspects, an insufficient level of knowledge and understanding of the manufacturing processes of active substances by their producers. This lack of process understanding contributed to quality issues affecting active pharmaceutical ingredients (APIs) and to inadequate measures to control contamination by impurities. The report on the nitrosamine case ultimately recommended making the application of Annex 15 mandatory also for API manufacturers.

This recommendation was taken up in 2024 during the 115th meeting of the GMDP IWG and has now led to the publication of the new Concept Paper by EMA and PIC/S, the international scheme for cooperation in pharmaceutical inspections.

Objectives of the revision

According to the document, the revision aims to extend the scope of Annex 15 to manufacturers of active substances, both chemical and biological. The update will also introduce selected modifications to the current text and strengthen the link with the provisions set out in Part II of the EU GMP guidelines, which specifically address active substances. Another key objective is to align the Annex more closely with the ICH Q9 (R1) guideline on Quality Risk Management, in order to ensure greater consistency between the two frameworks when making decisions related to qualification and validation activities.

The Concept Paper indicates that greater emphasis should be placed on the validation documentation for active substances, including the Validation Master File, as well as on the definition of a clearer qualification and validation policy. Such a policy should specify roles and responsibilities, the criteria used, including acceptance criteria, and the monitoring strategies adopted during the lifecycle of the manufacturing process.

A lifecycle-based approach to validation

At the core of the proposed revision is the introduction of a lifecycle-based approach to validation. This approach would cover the entire process lifecycle, from process design and qualification to ongoing performance monitoring and final evaluation, based on data and metrics collected throughout the manufacturing lifecycle.

The Concept Paper also highlights the need for robust procedures to investigate non-conforming results, supported by appropriate corrective and preventive actions (CAPA). In the area of qualification, the revision is expected to strengthen several key concepts, including the definition of User Requirements Specifications (URS) and the role of Factory Acceptance Testing and Site Acceptance Testing (FAT/SAT).

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