Susan Haigney

European Union Healthcare: A close-up of white and red capsules symbolizing healthcare against a backdrop of the European Union flag, signifying health and well-being in a European context. | Image Credit: ©pattozher -stock.adobe.com

The European Medicines Agency (EMA) announced the publication of its 2025 Annual Report on June 11, 2026,

 revealing a strong year of regulatory output across both human and veterinary medicines—along with significant advances in biosimilar policy, medicines availability, and the integration of artificial intelligence into agency operations. EMA recommended 104 human medicines for marketing authorization in 2025, of which 38 contained a new active substance that had never previously been authorized in the European Union.

Among the notable human medicine authorizations highlighted in the report were first-in-class and first-in-indication approvals including Rezdiffra, the first authorized treatment for metabolic dysfunction-associated steatohepatitis in the EU; Brinsupri, the first treatment for non-cystic fibrosis bronchiectasis; Teizeild, a first-in-class therapy to delay onset of stage 3 type 1 diabetes; and Waskyra, the first medicine for Wiskott-Aldrich syndrome. Several of these were advanced therapies or gene therapy products, reflecting a continuing shift in the EU's approval mix toward complex biologics and cell and gene therapies.

Three medicines—Brinsupri, Vimkunya, and Yeytuo—received recommendations following accelerated assessment, a pathway reserved for medicines addressing unmet medical needs that compresses the maximum review timeline from 210 to 150 days. In addition, 8 drugs received conditional marketing authorization, enabling early patient access before all data are received.

What Were Some of the Developments in Biosimilars, Critical Medicines, and AI?

In April 2025, EMA published a draft reflection paper proposing a tailored clinical approach for biosimilar development.

 The paper suggested that demonstrated structural and functional comparability, combined with pharmacokinetic data, may be sufficient to establish biosimilarity —potentially reducing the requirement for extensive clinical efficacy studies. The agency noted in the report that this shift has already generated an increased volume of biosimilar scientific advice requests, suggesting sponsors are actively exploring the new pathway.

The report also covers the official launch of the EU Medicines Agencies Network Strategy to 2028, continued maintenance of the Union List of Critical Medicines, and the full operationalization of the European Shortages Monitoring Platform (ESMP) in 2025—all of which have direct implications for manufacturers' supply chain planning and regulatory compliance strategies. The ESMP creates new visibility requirements around stock positions for critical medicines, and manufacturers supplying the EU market should ensure their shortage reporting processes are aligned with the platform's requirements.

The report also highlights how digitalization and artificial intelligence (AI) have reshaped the agency’s operations in 2025, moving from exploratory phases into practical application. The agency is expected to increase its use of AI-assisted review tools in the coming years, with potential implications for how manufacturers should structure and submit dossiers.

The year also marked EMA's 30th anniversary and the 25th anniversary of the EU Orphan Regulation, which has played a central role in facilitating the development and authorization of medicines for rare diseases. Sixteen of the recommended human medicines in 2025 were for rare disease indications.

“Currently, we are operating in a period of rapid transformation, defined by new ways of working and major legislative changes,” Rui Santos Ivo, chair of the EMA Management Board, stated in the forward of the report.

 “These developments underscore how essential it is for EMA and the network to remain forward looking, agile, efficient, and firmly committed to safeguarding the EU’s high standards for human and animal health while serving all European citizens. They also highlight the need for ever-closer coordination and solidarity across the European medicines regulatory network as we respond to shared pressures on resources, expertise and capacity.”

The full 2025 Annual Report, including detailed statistics and committee highlights, is available on the EMA’s website.

EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines. Press release. EMA. June 11, 2026. Accessed June 11, 2026. 

https://www.ema.europa.eu/en/news/emas-2025-annual-report-shows-strong-approval-numbers-human-veterinary-medicines

Annual Report 2025. The European Medicines Agency’s contribution to science, medicines and health in 2025. EMA 2026. Accessed June 11, 2026. 

https://www.ema.europa.eu/en/documents/annual-report/2025-annual-report-european-medicines-agency_en.pdf

Reflection paper on a tailored clinical approach in biosimilar development. EMA. March 27, 2026. Accessed June 11, 2026. 

https://www.ema.europa.eu/en/reflection-paper-tailored-clinical-approach-biosimilar-development

Articles

EMA’s 2025 annual report details 104 positive opinions for human medicines, including 38 new active substances, underscoring continued momentum in first-in-class and advanced therapy approvals. Notable recommendations included first EU treatments for MASH, non-CF bronchiectasis, stage 3 type 1 diabetes delay, and Wiskott-Aldrich syndrome. Accelerated assessment supported 3 products, while 8 received conditional marketing authorization. Policy and operational priorities emphasized a streamlined biosimilar evidence paradigm, strengthened critical-medicines shortage surveillance via ESMP, and expanded AI-enabled regulatory workflows.

The EMA’s annual report shows the agency approved 104 human drugs in 2025 that included first-in-class and first-in-indication therapies. 

EMA Approved 104 Human Medicines in 2025 

The development of and access to radiopharmaceuticals depends on a well-defined strategy. 

 spoke with Nicholas Richardson, vice president of clinical development at Precision for Medicine, to find out more about how these products are used to treat cancer and what developers should know about bringing these treatments to patients.

What is unique about the use of radiopharmaceuticals to treat cancer?

 For radiopharmaceuticals, we're talking about products that have the precision of targeted therapy with the cytotoxicity of radiation that is able to be delivered systemically. And what this does is allows for an effect at the site of disease, given all these novel components coming together in one therapeutic product.

And so, when we think about radiopharmaceutical programs, the other thing that is unique about them is they often pair diagnostic and therapeutic aspects to their product. And what that does is it supports diagnostic imaging for the patient, real-time biodistribution assessment, and personalized dose optimization based on dosimetry, which again, is very unique to radiopharmaceuticals. And then lastly, we think about radiopharmaceuticals in that they really do need a specific operational and infrastructural dependence.

Because they are linked to nuclear medicine infrastructure, they have imaging capabilities that are needed to be able to conduct trials for radiopharmaceuticals. And then you also need that radiation safety expertise.

And so, these are really the reasons that set radiopharmaceuticals apart when you think about them and the development of these products compared to other drug products for patients with cancer.

What are some of the specific challenges associated with patient access to radiopharmaceuticals?

It's always great to think about access, and especially in the context of radiopharmaceuticals. When we think about access for patients, it's really multi-dimensional when we are talking about a radiopharma product, and that is because it relies on supply, infrastructure, the regulatory oversight that's needed, and also the healthcare system readiness.

And so, because these products are governed by radioactive decay, this requires a very specific delivery paradigm with just-in-time delivery.

And when you think about this, this type of delivery is very dependent on the isotope production and the capability of producing this isotope, and then taking that and needing rigorous coordination across manufacturing, radiolabeling, distribution, and getting it actually to the site so the site can administer it to the patient.

And then when you think about it from the site standpoint, they need to have nuclear medicine licensing. They need to have radiopharmacy capabilities, radiation safety infrastructure, and trained personnel, which right now there is a shortage of trained personnel when we are talking about radiopharmaceuticals and the ability to administer these products to patients.

And then lastly, when we think about regulations, the regulations embody both drug regulatory frameworks, along with nuclear and radiation regulations and safety oversight.

And so, taking those two together, it really creates a very complex system that the developers have to navigate in order to be able to be successful in conducting clinical trials with radiopharmaceuticals in patients with cancer.

How can patient access planning be incorporated into the development of radiopharmaceuticals?

When we think about clinical development of radiopharmaceuticals, I think a lot of it does come back to what we were just talking about with patient access and the ability to get patients to enroll on these clinical trials.

I think it comes down to your site strategy along with an integrated supply chain, because we know that these products have really transformative potential benefit for patients. I think it really does come down to that infrastructure that you can set up in your development program. The way that you can think about that is can you identify centers of excellence with nuclear medicine capability that also would afford site readiness?

Is there a paired isotope that affords the ability to scale when you think about these products and the need to be able to produce the product for that just-in-time delivery, and whether you can actually scale it as your program continues to expand.

And then we had mentioned this before, but again, the co-development of a radiopharmaceutical that supports diagnostic and therapeutic implications is very patient-centric when you think about the real-time capabilities of these products with a patient going in, getting very specific imaging for the radiopharmaceutical diagnostic.

You get information on biodistribution that's specific to that patient. And then for the therapeutic standpoint, you're able to have individualized dosing.

When you think about patient access and the ability to support development, these are really benefits that are patient-centric, that are going to allow you to enroll and successfully conduct your trial.

And I would just say as a last point, the thing I think that also is needed when you think about development of these products is a patient's time, and that being a really important factor when you think about a radiopharmaceutical, because the schedule of assessments does need to take into account the unique aspects of these products.

There often is a need for inpatient hospitalization, so trying to balance that time where a patient is spending in the hospital versus are there opportunities for outpatient aspects of your schedule of assessments.

And then also the frequency of testing required, which a lot of time is dictated by the half-life of the isotope and what stage of development you're in.

But that patient burden and schedule of assessments I do think is critical when you think about radiopharmaceuticals and the successful ability to incorporate some of these aspects into the development to ensure success of your program.

You know, when we think about radiopharmaceuticals, they are unique. They do require an integrated therapeutic system when we are trying to ensure access and safe administration for patients with cancer.

And it really comes down to that we know that these products have transformative potential, and it's being realized more and more with the products that are currently approved and the number of products that are being developed, which we've really seen a surge in the last few years of radiopharmaceutical products, especially in the field of patients with cancer.

And so, I think as a community, we really just need to come together, ensure that our strategies are in place, and that we have a plan to be systematic, allow these products to be scalable, and really allow patients to receive the benefit that there is for these products, given the unique aspects of radiopharmaceuticals and the ability to target, patients with, you know, serious and life-threatening diseases with these cancers that we are, trying to develop in.

Nicholas Richardson is a hematologist oncologist and vice president of clinical development at Precision for Medicine, an oncology and rare disease-focused contract research organization. Prior to joining Precision, Richardson was formerly at the FDA for nearly 10 years as a prior FDA oncology, deputy director.

Radiopharmaceuticals merge the precision of targeted agents with systemically delivered radiation cytotoxicity, often integrating diagnostic and therapeutic functions. This theranostic paradigm enables imaging-based biodistribution assessment and individualized dosimetry-driven dosing. Patient access is constrained by decay-limited, just-in-time supply chains, nuclear medicine infrastructure requirements, dual regulatory oversight (drug plus radiation), and shortages of trained personnel. Development programs should incorporate access planning early through center-of-excellence site selection, scalable isotope production and distribution, and patient-centric scheduling that balances inpatient needs with outpatient opportunities and half-life–driven monitoring.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients. 

Patient Access to Radiopharmaceuticals

Demand surge and supply critical issues highlight healthcare system overload with scattered medicine pills on wooden surface under warm light | Image Source: ©Enjoy -stock.adobe.com

Note: This story has been updated to include comments from Matt Christian, director of Supply Chain Insights at USP.

The US Pharmacopeia (USP) published its annual drug shortages report on June 9, 2026.

 The report finds that drug shortages are lasting longer, up from 2 years in 2019 and 4.3 years in 2024 to 5 years in 2025. Product discontinuation is also at a high level, with a 60% increase from 2024 to 2025. However, the total number of shortages decreased by 23% in 2025.

According to USP, shortages are due to low prices, geographic concentration, and quality concerns that are complicated by manufacturing complexity, natural disasters, geopolitical pressures, and policy changes. A combination of factors can be at fault, such as the complexity of sterile injectable drugs, which make up 71% of shortages.

“Manufacturers of generic drugs and their ingredients operate on thin, sometimes unsustainable margins,” said Matthew Christian, director of Supply Chain Insights at USP, in the press release.

 “This report shows a relationship between prices received by manufacturers and continued production. Product discontinuations add to supply fragility and risk of future shortages if supply cannot meet demand.”

USP analyzed drug shortage data from the FDA that was current as of December 31, 2025. In addition, USP used data on key starting materials (KSMs), which have been added to USP’s Medicine Supply Map (MSM).

The USP MSM Shortage Risk Model is used to predict shortages, with an accuracy of 96%. When the model flagged a drug as at risk, the prediction was correct 80% of the time and identified 82% of active shortages reported by the FDA and the American Society of Health-System Pharmacists. Predictive analysis was used to analyze the USP MSM data.

“Performance on entirely new injectable shortages, the dosage form where supply disruptions carry the greatest patient risk, is harder to assess given the small sample size. (There were only two new injectable shortages reported by FDA in 2025). The model correctly identified 50% of new injectable shortages as high risk (see Appendix A for USP’s risk scores.),” the report states.

The KSM data indicates that geographic concentration may begin earlier in the supply chain, with 44% of drugs that are in short supply having at least 1 KSM that is manufactured in one single country.

Why Are Shortages Lasting Longer and Why Are Discontinuations Increasing?

According to the USP report, the duration of drug shortages increased to 5.3 years in 2025. This is a result of new shortages declining, and therefore, long-standing shortages become the bulk of the total number.

“More than half (64%) of the drugs in shortage have been in shortage for more than 3 years, with 29 (39%) drugs being in shortage for more than 5 years,” the report states.

 “Increased durations of drug shortages are a critical public health risk that can lead to compromised patient care, treatment delays, and unfavorable outcomes. Without intervention, prolonged shortages will continue to directly burden patients and healthcare providers.”

“Our data shows that although the number of drugs in shortage has declined in the last year, those that remain are lasting longer, with an average duration of five years,” Christian told 

. “Persistent shortages are rarely caused by a single issue and typically result from a combination of factors, including low prices, geographic concentration of production, manufacturing complexity, and quality concerns. 

“For example, many of the affected products are low-cost generic medicines, where manufacturers often operate on very thin margins. When reimbursement and purchasing models prioritize the lowest possible price, manufacturers may have limited ability or incentive to invest in quality improvements, redundancy, or additional production capacity.

“This complexity makes shortages last for longer durations, harder to resolve, and leaves supply chains vulnerable to future disruptions. Understanding these drivers and their impact on the supply chain of a specific medicine is essential to identifying and addressing systemic vulnerabilities to prevent and resolve shortages,” Christian explained to 

The 2025 increase in drug discontinuations—a 60% year-over-year rise—is the largest since December 2019. USP states in the report that discontinuations of drugs happen for a variety of reasons, such as formulation changes and portfolio consolidation. The organization speculates that the price of discontinued products may indicate a fragility in the market. Two-thirds of discontinued oral solid dosage products were priced below $1 per unit, with the median price falling by 78% in one year. More than a third of discontinued injectable drugs (35%) were priced below $15 per unit. “These findings suggest that very low prices may be closely associated with a higher likelihood of discontinuation,” the report states.

What Do These Numbers Mean for the Industry?

The data indicate that a variety of therapeutic categories are impacted by shortages. However, pediatric drugs appear to be impacted at a higher rate, with 16 shortages compared with the least impacted category, oncology, with 6 shortages.

Six of the pediatric drug shortages are intravenous (IV) fluids and additives, which are often used for other drugs. Shortages of these types of products create interrelated problems: IV fluids may be rationed by doctors; a shortage of a common diluent, such as dextrose, may increase shortages in other therapeutic classes; these shortages may also change dosing protocols and increase the use of substitutions that may continue after the shortage is over. 

“When supplies are limited, clinicians may need to prioritize the most acute cases, and pediatric patients often have less margin for error due to their size and developmental physiology,” Christian told 

. “Shortages of products like dextrose can also create downstream challenges across multiple therapeutic areas because they are used in other medicines.”

“These findings underscore a fundamental reality: today’s market does not reward resilience,” said Anthony Lakavage, executive vice president for Global External Affairs at USP, in the release.

 “Policymakers and stakeholders must act to realign incentives—establishing clear benchmarks for supply reliability, creating sustainable payment mechanisms that value quality and continuity, and advancing reforms that strengthen the foundation of our medicines supply chain.”

 about USP’s efforts in securing the supply chain.

 “For years, supply chain fragility has been tied to ongoing drug shortages, the system hasn't been able to absorb a wide range of disruptions,” Lakavage explained. “But now there's a growing concern that the medicine supply chain could essentially be weaponized through trade. The concentration of key starting materials in China in particular represents a real vulnerability, both for national security and patient care.”

When asked how tariffs and other geopolitical disruptions may have impacted drug shortages, Christian explained to 

that, “While generic drugs have largely been exempt from tariff policies, disruptions can put pressure on already fragile supply chains and bring into focus a challenge that has been building for years: the medicines supply chain has become highly concentrated and overly reliant on a limited number of manufacturers, suppliers and production regions.

“When production of critical ingredients and finished medicines is concentrated in a few countries or specific locations, impacts on supply during a conflict or crisis can be even more significant. For example, if a country that controls a high percentage of the U.S. medicine supply is cut off from global shipping routes, patients won’t be able to get the treatments they rely on.”

Christian stressed that shortages should not be seen as isolated events, “but as symptoms of broader supply chain risks. The fact that shortages are lasting longer than ever suggests that the system has less flexibility to absorb disruptions—like geopolitical conflicts, natural disasters, and manufacturing quality issues—when they occur.”

USP Annual Drug Shortages Report finds rising discontinuations, hidden upstream risk. Press release. USP. June 9, 2026. 

https://www.usp.org/news/usp-2026-annual-drug-shortages-report-rising-discontinuations-supply-chain-risk

USP. 2025 USP Annual Drug Shortages Report. US Pharmacopeia. June 2026.

USP Medicine Medicine Supply Map. USP.org. Accessed June 9, 2026. 

https://www.usp.org/supply-chain/medicine-supply-map

Lakavage T, Haigney S, Zubulake Z. How USP Is Navigating Global Disruptions and Building a Better Future for the Industry. PharmTech.com. March 27, 2026.

 https://www.pharmtech.com/view/how-usp-is-navigating-global-disruptions-and-building-a-better-future-for-the-industry

Lakavage T, Haigney S, Zubulake Z. Inside USP’s Strategy to Fortify Medicine Supply Chains. PharmTech.com. March 23, 2026. 

https://www.pharmtech.com/view/inside-usp-s-strategy-to-fortify-medicine-supply-chains

US Pharmacopeia data show fewer total FDA-reported shortages in 2025 (–23%) but markedly longer persistence, with mean duration rising to 5.3 years and 64% extending beyond three years. Product discontinuations surged 60% year over year, correlating with very low unit pricing in both oral solids and injectables. Root causes reflect thin generic margins, geographic concentration of inputs, and quality/manufacturing complexity, particularly for sterile injectables. New analytic work incorporating key starting materials highlights upstream single-country dependencies.

The standards organization’s annual drug shortages report finds drug shortages lasting longer and the number of discontinuations rising, but the number of shortages themselves have gone down.

USP Reports Drug Discontinuations on the Rise

PharmTech Weekly Roundup—June 5, 2026

Three themes drove the headlines this week: regulatory reform, patient access, and supply chain security.

From the FDA and the European Medicines Agency (EMA) to the International Council for Harmonisation (ICH) and the US Pharmacopeia (USP), standards are being rewritten across biologics, biosimilars, and gene therapies, and that's changing how manufacturers build their development programs.

Whether it's affordable GLP-1s in Canada, inhaled insulin for children, or radiopharmaceuticals for oncology patients, the pressure to get more therapies to more patients, at lower cost, is front and center.

From Delaware's reshoring push to global Ebola response, the question of where medicines are made—and who controls that—has never been more urgent.

the EMA, the African Medicines Agency, and national regulators across Africa

 launched the first joint regulatory collaboration to fast-track clinical trials and countermeasures for the active Ebola outbreak in the DRC and Uganda—a virus for which no authorized vaccines or treatments currently exist.

 has released its first set of product-specific biologics standards and invited stakeholders to comment on a framework designed to reduce regulatory variability and accelerate market access for biologics and biosimilars.

 allowing sponsors to leverage existing CMC, nonclinical, and clinical platform knowledge—including published literature, master files, and consortium data—in gene therapy submissions, aiming to cut development costs and timelines for patients with rare and life-threatening diseases without compromising safety standards.

 for children aged six and older signals growing momentum for dry powder biologic delivery—but also underscores the significant manufacturing complexity involved, including precision particle engineering, specialized facility design, and a distinct regulatory documentation burden that developers must plan for early.

 made the case that domestic pharmaceutical manufacturing is a national security imperative—not just an economic one— and positioned Delaware's streamlined regulatory environment as the fastest, lowest-cost destination for reshoring production.

Delaware's biopharma strategy—anchored in public-private collaboration, expedited permitting, continuous manufacturing investment, and early-stage STEM workforce development—offers a scalable model for governments and industry seeking to accelerate drug development and domestic manufacturing.

Former FDA Oncology Center of Excellence Director Richard Pazdur

 also spoke at CPHI Americas, where he warned that staff turnover and inconsistent review standards at the FDA are creating a less predictable regulatory environment — and called for modernized Special Protocol Assessments, real-time oncology review, and stronger advisory committee practices to restore sponsor confidence.

On PharmTech.com this week, industry consultant, 

 explained how repurposing off-patent generics offers pharma companies a low-risk, faster path to cancer pipeline expansion by leveraging established safety profiles and existing manufacturing infrastructure.

discussed how new FDA and EMA guidance streamlines biosimilar development by reducing the need for comparative efficacy studies when analytical similarity is robustly demonstrated—but this shift places significantly greater demands on analytical characterization, PK studies, and bioanalytical rigor, while intensifying global competition.

provided insight on the company’s generic semaglutide injection that was approved in Canada in May—making it the first G7 country to authorize a GLP-1 generic—signaling a pivotal inflection point for manufacturers with integrated peptide synthesis capabilities as patent exclusivities erode across major markets.

explained how the 2024 implementation of ICH Q5A(R2) modernizes viral safety for biologics manufacturing by formalizing next-generation sequencing for adventitious agent detection, introducing continuous manufacturing provisions, and enabling platform prior-knowledge approaches—giving CMC teams concrete tools to shorten testing timelines while strengthening safety assurance.

Nicolas Richardson of Precision for Medicine 

talked about how successful radiopharmaceutical development requires a site strategy built around nuclear medicine-ready centers of excellence and isotope pairs that support scalable just-in-time delivery.

Regulatory modernization, patient access, and supply chain security are the threads connecting this week's stories. The decisions being made right now in guidance documents, state legislatures, and manufacturing facilities will shape the industry for years to come. Be sure to watch the interviews and read the articles on PharmTech.com.

Regulatory and standards bodies are accelerating modernization across biologics, biosimilars, and gene therapies, reshaping evidence expectations and CMC strategies through greater use of platform knowledge and advanced analytics. Patient access pressures are rising, from pediatric inhaled insulin and radiopharmaceutical logistics to Canada’s first G7 approval of generic semaglutide. Supply chain sovereignty is reframed as national security, with US reshoring initiatives highlighting expedited permitting, continuous manufacturing, and workforce development. Concurrently, regulators launched a pan-African Ebola collaboration to fast-track trials amid an outbreak lacking authorized countermeasures.

Regulatory reform, patient access, and supply chain security were 3 of the key themes showcased this week on PharmTech.com.

Ebola virus outbreak biosecurity interface in medical laboratory, infectious disease prevention healthcare emergency, quarantine containment diagnostics vaccine research, public health | Image Credit: ©Sapra -stock.adobe.com

The European Medicines Agency (EMA) announced on June 3, 2026 that the agency’s Emergency Task Force (ETF) is discussing clinical trial designs and medical countermeasures to the Ebola outbreak in the Democratic Republic of the Congo (DRC) and Uganda with the African Medicines Agency (AMA) and its national regulatory authorities (NRAs).

 The organizations are leveraging expertise from the World Health Organization (WHO)-AFRO African Vaccines Regulatory Forum (AVAREF) to address the Ebola outbreak caused by the Bundibugyo virus. The collaboration, the first since the AMA was started, will support “efficient, coordinated and timely regulatory responses to the outbreak”

that will build on experience gained from previous Ebola outbreaks, joint reviews conducted by the AVAREF, and EMA operations.

WHO declared the Ebola outbreak caused by the Bundibugyo virus an international public health emergency on May 17, 2026.

 No authorized vaccines or treatments currently exist for Bundibugyo virus disease, and existing countermeasures that target the Zaire Ebola virus might not be effective, according to EMA.

The agency says there are antivirals and investigational pan-filovirus monoclonal antibodies (mAbs) in development that may be effective against Bundibugyo and should be advanced into clinical trials. “Vaccine candidates should also be rapidly developed and could then be progressed into late-stage clinical trials by establishing regulatory criteria that would ensure both scientific rigor and speed,” the agency stated in the press release.

What Are the Potential Treatments and Vaccines in Development?

EMA’s ETF has been investigating potential treatment candidates, alongside treatment developers and WHO, and has identified 3 possible vaccine candidates, 3 possible treatment candidates, and 1 potential post-exposure prophylaxis (antiviral obeldesivir).

The 3 vaccine candidates include a recombinant vesicular stomatitis virus (rVSV)-based Bundibugyo vaccine, a Bundibugyo virus vaccine using the ChAdOx1 modified adenovirus platform, and a messenger RNA vaccine. The treatment candidates are MBP-134, a combination of 2 mAbs active against different ebolaviruses including Bundibugyo virus, the antiviral remdesivir, and the mAb maftivimab.

Discussions with developers, academia, and funders to advance these medical countermeasures have already begun. The organizations involved are looking at the aspects of development and critical trial design to demonstrate safety and efficacy of the potential treatments and vaccines. These discussions include the potential for different uses of the products, including prophylaxis and post-exposure prophylaxis. “Prompt and flexible regulatory decisions that are anchored on solid scientific evidence are key to ensure an effective public health response in the context of this emergency,” EMA stated in the release.

European Centre for Disease Prevention and Control

 (ECDC) stated on its website that the outbreak continues to impact the DRC and Uganda. The DRC Ministry of Health reported that there is a total of 344 confirmed cases that include 60 deaths, and 116 suspected cases as of June 1, 2026. The most affected province is Ituri, with 322 confirmed cases. Uganda has reported 15 confirmed cases and one death. The ECDC stresses that the risk of cases in the EU/EEA is “very low”.

“National authorities, in collaboration with WHO and partners, are implementing response measures including deployment of rapid response teams, delivery of medical supplies, strengthened surveillance, laboratory confirmation, infection prevention and control, the set-up of safe and optimized treatment centers, and community engagement,” WHO states on its website.

EMA, AMA and African regulatory authorities join forces on Ebola outbreak response. Press release. EMA. June 3, 2026. 

https://www.ema.europa.eu/en/news/ema-ama-african-regulatory-authorities-join-forces-ebola-outbreak-response

Epidemic of Ebola Disease caused by Bundibugyo virus in the Democratic Republic of the Congo and Uganda determined a public health emergency of international concern. Press release. WHO. May 17, 2026. 

https://www.who.int/news/item/17-05-2026-epidemic-of-ebola-disease-in-the-democratic-republic-of-the-congo-and-uganda-determined-a-public-health-emergency-of-international-concern

Ebola disease outbreak in the Democratic Republic of the Congo and Uganda. ECDC. June 3, 2026. Accessed June 3, 2026. 

https://www.ecdc.europa.eu/en/ebola-outbreak-democratic-republic-congo-and-uganda

Ebola disease caused by Bundibugyo virus, Democratic Republic of the Congo & Uganda. WHO. Accessed June 3, 2026. 

https://www.who.int/emergencies/disease-outbreak-news/item/2026-DON605

EMA’s Emergency Task Force is coordinating with the African Medicines Agency and national regulators, leveraging WHO-AFRO/AVAREF expertise, to accelerate scientifically rigorous clinical trial designs and regulatory pathways for Bundibugyo ebolavirus countermeasures in DRC and Uganda. With no authorized Bundibugyo-specific vaccines or therapeutics and uncertain cross-protection from Zaire-directed products, the focus is rapid advancement of antivirals and investigational pan-filovirus mAbs, alongside fast-tracked vaccine development. As of June 1, 2026, DRC reported 344 confirmed cases and 60 deaths; Uganda reported 15 cases and one death.

EMA, AMA, and national regulatory authorities in Africa are working on potential clinical trial designs and medical treatments for the Ebola outbreak in the DRC and Uganda.

EMA Collaborates with African Regulators on Ebola Treatments

Single use syringe for injection treatment on medical table with vials of liquid drug doses flu shots at background. Vaccination or immunization care concept | Image Credit: ©Mikhailov Studio -stock.adobe.com

The US Pharmacopeia (USP) announced on June 1, 2026 that it has published a set of product-specific biologics emerging standards that offer multiple methods for the assessment of quality attributes, which do not include limits, leaving those determinations to the reviewing regulator.

 The methods should enable alignment with regulators, and therefore, create more efficient regulatory reviews and facilitate market access. Included in the first set of standards, along with physical reference standards, are analytical methods for epoetin, 

. The standards were developed as part of a 2025 resolution by USP to develop tools to advance access to biologics and biosimilars.

“Biologic therapies require approaches that are scientifically rigorous, workable in real-world settings, and that account for the complexity of biologics, which is why we are publishing these for stakeholder comment for early engagement and feedback,” said Diane McCarthy, Ph.D., vice president, Global Biologics at USP, in a press release.

 “These product-specific emerging standards are designed to focus on analytical methods and system suitability tests and criteria, supporting consistent assessment of assay performance, and efficiency in how analytical evidence is generated and assessed.”

According to USP, scientific advances integrated into review frameworks by regulators over the past few years, including the use of analytical evidence with fewer clinical data, may create inconsistency due to a lack of common expectations on appropriate methods for product testing, as well as the interpretation of data. USP believes the published standards will help to provide a common framework.

“As regulators increasingly rely on analytical data to evaluate biologics, establishing shared approaches to assessing quality becomes critical,” said Fouad Atouf, Ph.D., chief science officer at USP, in the press release.

 “Publicly available standards and tools can help reduce uncertainty, streamline development and review, and support broader availability of quality biologic therapies for patients. We look forward to active stakeholder engagement and input.”

The standards are available for early stakeholder input from regulators, manufacturers, academia, and healthcare providers before the formal compendial process. Comments can be made through the 

 interview with Tony Lakavage, USP’s executive vice president and head of Global External Affairs. Lakavage provides his insights on drug supply chain vulnerabilities, trends in R&D, and navigating global distruptions.

“USP standards are used in roughly 22,000 manufacturing facilities worldwide that supply medicines to the US and to 140 countries globally,” Lakavage said in the interview.

 “When we update our standards to reflect modern, more sustainable technologies, the impact is enormous. USP's membership recently passed a resolution making this a key objective for the next 5 years: integrating modern technologies into our standards to reduce the industry's overall environmental footprint. That includes eliminating animal testing, reducing reliance on toxic chemicals, and finding greener alternatives at every step.”

USP publishes product-specific emerging biologics standards for public comment. USP. Press release. June 1, 2026. 

https://www.usp.org/news/usp-publishes-product-specific-emerging-biologics-standards-for-public-comment

Lakavage T, Haigney S, and Zubulake Z. Inside USP’s strategy to fortify medicine supply chains. PharmTech.com. March 23, 2026. 

Lakavage T, Haigney S, and Zubulake Z. Top pharmaceutical industry trends impacting R&D and manufacturing. PharmTech.com. March 24, 2026. 

https://www.pharmtech.com/view/top-pharmaceutical-industry-trends-impacting-r-d-and-manufacturing

Lakavage T, Haigney S, and Zubulake Z. How USP is navigating global disruptions and building a better future for the industry. PharmTech.com. March 27, 2026. 

https://www.pharmtech.com/view/how-usp-is-navigating-global-disruptions-and-building-a-better-future-for-the-industry

USP has released product-specific emerging biologics standards providing multiple analytical methods and system-suitability criteria—without prescribing acceptance limits—to support regulator-aligned quality attribute assessment. The initial package includes physical reference materials and assays for epoetin, interferon beta‑1a, rituximab, and bevacizumab, stemming from a 2025 access-to-biosimilars resolution. The initiative responds to increasing regulatory reliance on analytical evidence with reduced clinical datasets and aims to harmonize testing expectations and data interpretation. Stakeholder comments are solicited via an Emerging Standards Platform, alongside broader modernization and sustainability goals for compendial standards.

The organization’s set of product-specific biologics emerging standards are available on its Emerging Standards Platform for public comment.