A New Era for Excipients: Key Takeaways from the IPEC Europe Excipients Forum 2026

Driven by regulatory evolution and a commitment to sustainability, the excipients’ sector is reinforcing its position as a sophisticated and credible stakeholder in the modern pharmaceutical supply chain.

The pharmaceutical excipient landscape is undergoing a period of unprecedented transformation. Traditionally viewed as more of a backdrop to potent APIs, excipients are moving to the forefront of regulatory scrutiny, environmental strategy, and manufacturing innovation. The recent IPEC Europe Excipients Forum, held on Feb. 5, 2026 in Torremolinos, Spain, served as a critical forum for stakeholders to dissect these shifts.

The Strategic Shift: Sustainability and Digitalization at EDQM

Dr. Petra Doerr, Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM) started the day’s presentations with an overview of its latest initiatives and activities. First on the agenda was an update on EDQM’s strategic framework, including the roadmap for sustainable development, the sustainability initiatives, and certificates of suitability (CEPs) for excipients.

Aligning with the Council of Europe’s goals, EDQM is seeking to become carbon neutral by 2050, Doerr revealed. After having conducted an audit in 2024, the organization’s current carbon footprint was realized. Based on the audit, it was demonstrated that the distribution of reference standards to over 130 countries accounts for over 60% of the EDQM’s carbon footprint, which represents the main challenge in meeting their proposed goal, Doerr specified.

Several actions have been highlighted for development to help reduce carbon emissions, such as the replacement of certain high emission fluids, grouping regular shipments, and so forth, she added.

Additionally, to incorporate sustainability into the strategic framework of EDQM, the directorate is not only overhauling its physical premises but also integrating green criteria into European Pharmacopoeia (Ph. Eur.) methods. A pivotal milestone was reached in January 2026, marking the end of mandatory animal-based general safety tests in the Ph. Eur., a move that aligns ethical considerations with modern scientific capabilities, Doerr confirmed.

“In November 2025, the Ph. Eur. Commission has decided to establish an Environmental Sustainability Working Party,” Doerr stated. “The mandate of this working party will be on the one hand to establish all the methods and activities that are ongoing, and then, on the other hand, to look into providing advice and supporting other European Pharmacopoeial groups on how to integrate environmental decision making into their work. Also [the group will be responsible for] proposing a strategy for the Ph. Eur. on the environment.”

The third element of the strategy is being worked on between 2024 and 2027 and will focus on CEPs for excipients. Currently, the majority of CEPs have been established for Active Pharmaceutical Ingredients (APIs) as these are active substances and there is no specific guidance for excipients. Therefore, manufacturers consider the requirements for obtaining a CEP for an excipient too complicated. “In the EU, where there is a Ph. Eur. monograph for an excipient, compliance to the monograph is generally considered sufficient to cover its quality in the marketing authorization application,” Doerr said.

However, feedback from industry stakeholders, including IPEC, has revealed that there is consensus that the CEP procedure is not fit for excipients and may potentially lead to misuse. Therefore, EDQM has commenced a dedicated CEP for excipients project, under development for 2024–2027; although implementation will require further alignment with national regulatory agencies, Doerr revealed.

For the second part of her presentation, Doerr highlighted updates on the excipient program of the Ph. Eur.“The future work program on excipients at the European Pharmacopoeia will be driven by the outcome of the work of the Excipients Strategy Working Party (EXS),” she added.

“For the EXS, we have work ongoing to identify and discuss best possible approaches to address the quality standard setting process of excipients for pharmaceutical use in the Ph. Eur.,” Doerr continued. Here, the focus of the group is on the control of components in the individual monographs, and, also, the control of impurities in the monographs, particularly following ICH Q3A, where an impurity is any component that is not the defined chemical entity, she explained.

Additionally, Doerr noted the digital milestone for EDQM with the transition to an online-only 12th Edition of the Ph. Eur. By moving to an online-only platform and retiring the printed version — the “Blue Book” — the EDQM is facilitating more agile future updates, which is essential for evolving standards.

Regulatory Evolution: Co-Processed Excipients

In the second morning session presentation, Ivana Taševská, Pharmaceutical Assessor, Czech State Institute for Drug Control, and part of EMA’s Quality Working Party, shared information about the recently published Q&A document, which she was involved in drafting, on co-processed excipients (CoPEs). Work on the Q&A guidance for CoPEs started in 2021 with the aim of harmonizing and clarifying dossier requirements for CoPEs in oral solid dosage forms for both human and veterinary medicines.

While not a legally binding document, the new Q&A guidance, set to take effect on Aug. 1, 2026, provides manufacturers with an interpretative tool for regulatory compliance. A new risk-based categorization of CoPEs has been introduced in the guidance to inform companies of the level of detail they may be required to provide in their marketing authorization dossier.

Taševská revealed that the categories of CoPEs have been defined as: category A for the highest risk CoPE; category B for medium risk CoPE; and category C for the lowest risk CoPE. The categorization of the CoPE in a drug product is based on the material attributes of the CoPE — such as its function, physicochemical properties, and proportion in the finished product — and related to the impact these have on the critical quality attributes (CQAs) and critical process parameters (CPP) of the finished product.

For example, a CoPE that comprises two excipients, functions as a filler in the finished drug product, has a lower risk of impacting the CQAs of the final drug product, and has a relatively low proportion in the finished drug is considered the lowest risk and would be placed into category C. However, a CoPE that functions as a retarding agent and disintegrant, does have a high risk of impacting the CQAs of the final drug, comprises four excipients, and has a relatively high proportion in the finished drug product would be classified in category A.

In terms of what is required in a marketing authorization dossier, Taševská explained that any CoPE that is considered to be in category A or B should include the name and address of the CoPE manufacturer, applicants must justify their choice of CoPE, and the potential impact on the finished product should be indicated.

Global Perspectives: China’s GMP and the WHO’s Fight Against SF Products

Before the lunch break, global perspectives were shared, starting with a comprehensive overview of the regulatory landscape for pharmaceutical excipients in China, given by Cloris Tian, Chair of IPEC China and Senior Regulatory Manager, Merck Life Science. China is a dominant force in excipient manufacturing with nearly 700 domestic excipient manufacturers registered at China CDE (Centre of Drug Evaluation), based on an article published at <Chinese Pharmaceutical Affairs> in 2021.

The focus for the country has shifted from the past “triangle” of excipient co-review system toward a “new triangle” of supervision involving the regulator, the excipient user, and the excipient maker, Tian commented. New mandatory Excipient GMP requirements have also been introduced and implemented since January 2026.

For international firms, China’s application to join the Pharmaceutical Inspection Co-operation Scheme PIC/S signals a move toward more harmonized inspection standards, though technical challenges — such as how to establish an overall excipient quality management system with a risk based approach to meet the intent of China excipient GMP requirements  — remain top of mind for the ~700 domestic manufacturers as well as overseas excipient manufacturers, Tian stated.

On a broader scale, the World Health Organization (WHO) is intensifying efforts to secure the supply chain against substandard and falsified (SF) medical products, as laid out by the organization’s Technical Officer, Pernette Bourdillon Esteve.

Following tragic incidents involving SF medical products, such as the cases of diethylene glycol poisoning, the WHO is modernizing the starting materials certification scheme (SMACS), Bourdillon Esteve stated. The revised scheme will now include all APIs, and will only focus on excipients that are considered to be high-risk, she explained. Additionally, a digital platform will be employed for audit reports.

This move by the global organization underscores the complexity of modern supply chains.

Panel Discussion: Elevating Excipient Status

To start the afternoon sessions, a panel of experts took centre stage to delve into the evolving regulatory landscape shaping excipients. The panel comprised: Bram Baert, Senior Director, Head of Regulatory Affairs Capsule and Health Ingredients at Lonza; Alexa Smith, Global Head of Innovation, Quality, and Regulatory Affairs, Colorcon; Samuel Charbonnier, Product Stewardship Manager at Imerys — member of Eurotalc; Stéphane Varlet, Global QA Technical Director at Proctor & Gamble; and Lotte Kok, QA Specialist at Novo Nordisk; and was moderated by Adrian Bone, Senior Advisor for IPEC Europe.

A major theme of the discussion was the necessity for a more collaborative and transparent relationship between industry stakeholders and regulatory bodies on the topic of excipients. The panel emphasized that while the industry is eager to improve quality through education and better stewardship, it requires more consistent feedback from regulators regarding specific inspection findings. This call for a two-way dialogue is seen as essential for evolving the current coordination systems, which many speakers felt were no longer sufficient to meet modern safety challenges. By understanding the specific deficiencies identified during audits, the industry can better align its educational and training initiatives to address real-world quality gaps — essential for building a robust regulatory framework that prioritizes patient safety above all else.

Further into the session, the panel reviewed the influence of cross-sector regulations, including food safety rules, chemical restrictions, and environmental requirements, on excipients. Additionally, the panelists highlighted the current trend towards growing regulatory scrutiny on excipients, which is sometimes shaped more by public perception than by scientific evidence. This trend has the potential to create supply-chain, compliance, and reformulation challenges for the pharmaceutical industry.

The session also addressed the historical undervaluation of the excipient sector, with experts arguing that the industry has matured far beyond its past reputation. To illustrate this growth, the panel pointed to the major CPHI Worldwide trade event, where the presence of dedicated excipient manufacturers has expanded from virtually zero a decade ago to more than 230 specialized booths today. This physical expansion reflects a deeper structural change in the market, where suppliers are increasingly recognized as critical partners in the drug development lifecycle.

Concluding the session, the panel reinforced that the excipient sector is a highly credible and trustworthy partner that is actively investing in infrastructure and quality systems. This credibility serves as a foundation for future developments, reinforcing that the excipient industry is no longer just a supplier of raw materials but a sophisticated stakeholder in the modern pharmaceutical landscape.

Managing Change: Perspectives from the User and Maker

Focusing on operations, Beverley Stout, External Quality Incoming Materials Senior Lead at GSK, and Philippe Lienart, Senior GxP Manager, Roquette’s Health & Pharma Solutions Business, shared their insights into the rigors of change control and the industry’s response to shifting global regulations.

A major focus of the first part of the session was the documentation and notification standards required for successful change management. GSK advocates for a “one change, one notification” standard, revealed Stout, requesting that suppliers provide detailed descriptions of current versus proposed states alongside robust stability and validation data. For major impacts, they expect notifications at least six months in advance, though twelve months is preferred.

Managing changes in excipients is a critical safeguard for patient safety, requiring a systematic and highly controlled approach to prevent quality failures, Stout asserted. The “eternity” often felt by suppliers during the change approval process is necessary because even minor modifications can lead to significant physical issues in the final product. In an environment where a minor unnotified change to an ingredient can result in a product “setting like concrete,” the demand for transparency is absolute, she remarked.

To demonstrate the user impact of regulatory changes, Stout highlighted the significant logistical challenge of the ban on FD&C Red No. 3 by the FDA and the Egyptian Drug Authority (EDA). Responding to this ban, GSK performed an intensive assessment process, reviewing 300 materials to identify 13 affected components, primarily capsule shells, she added.

However, reformulation is not merely a matter of aesthetics; color is key for product identification, particularly for elderly and visually impaired patients, Stout remarked. Furthermore, added challenges can arise when selecting alternatives, as there is a constant risk that natural or synthetic replacements might face their own future regulatory bans, she stressed.

In addition to colorant changes, both Stout and Lienart detailed the massive effort required to comply with the 2025 edition of the Chinese Pharmacopoeia (CP). GSK managed this transition for 170 excipients across 63 suppliers, coordinating global sites and massive translation efforts to meet the strict October 1, 2025 deadline. Roquette optimized this process by using artificial intelligence (AI) applications to compare the new Excipients China GMP regulatory framework against current standards, reducing a task that usually takes months to just 10 minutes. This exercise demonstrated how digital innovation is becoming a necessity for managing the sheer volume of modern pharmaceutical data.

Finally, the session concluded with a look at the French regulatory context through the lens of Roquette’s operations under the Agence Nationale de Sécurité du Médicament (ANSM) guidelines. Lienart highlighted a shift from rigid constraints toward a more holistic, risk-based approach to excipient quality and emphasized that the newest guidance requires manufacturers to “run the risk” through comprehensive internal assessments rather than simply checking boxes. This evolution underscores a broader industry trend where manufacturers must reinforce their own internal processes to ensure diversity and safety across their entire project portfolio.

The Frontier: 3D Printing and Decentralized Manufacturing

For the last session of the Forum, Kjeld van Bommel, Program Manager, TNO Holst Centre offered a glimpse into the future of personalized medicine — 3D printing. While the technology is still primarily focused on producing tablets, due to its relative nascency, the printing of capsules, patches, films, and even complex implants are being investigated. Noting that “3D pharma will become mainstream,” van Bommel suggested that while the technology is still currently in a high-growth research phase, it is destined to become a standard tool in the pharmaceutical arsenal, particularly for tailoring products to specific patient needs.

However, there are still technical and material challenges to overcome before the widespread adoption of 3D printing in the pharmaceutical sector will be possible, van Bommel specified. Additionally, as 3D printing allows for unique, individualized dosages, the industry must move toward a quality-by-design (QbD) approach, he asserted.

Looking at the regulatory landscape, van Bommel pointed out that, particularly for decentralized manufacturing, regulators are struggling to keep pace with technological advancements. He highlighted a major gap in existing frameworks, stating that “current regulations really lack the solution for licensing cartridges with APIs in them if they are distributed between different entities.” This legal uncertainty creates a barrier for companies looking to commercialize the pre-filled components necessary for 3D printing systems.

Despite these obstacles, the outlook for 3D pharmaceutical printing is overwhelmingly positive, with a massive increase in scientific publications and specialized conferences dedicated to the topic since 2010. Van Bommel emphasized that the goal of this technology is not to replace existing mass-production methods but rather to complement them by offering solutions for complex dosing or niche patient populations. As the technology continues to mature and regulatory bodies begin to address the unique requirements of point-of-care manufacturing, 3D printing is poised to become an integral component of modern healthcare delivery.

A Credible and Mature Industry

The overarching theme of the IPEC Europe Excipients Forum was the maturation of the excipient industry, with excipient manufacturers now taking a proactive partnership role in patient safety, investing in infrastructure and sustainability. As regulatory frameworks in Europe, China, and via WHO continue to tighten, the industry's ability to innovate through digital tools and transparent supply chains will be the defining factor in its success over the next decade.

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