CHAPTER 1: KEY ACHIEVEMENTS IN 2024
Evaluation and monitoring of medicines: highlights
Human medicines
Medicines recommended for approval
The authorisation of new medicines is essential to advancing public health as they bring new opportunities to treat or prevent certain diseases. In 2024, EMA recommended 114 medicines for marketing authorisation, including 46 with new active substances. The medicines recommended for approval in 2024 selected in this overview represent significant progress in their therapeutic areas:
Beqvez, a gene therapy treatment for haemophilia B, a rare inherited bleeding disorder.
Emblaveo, an antibiotic for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by aerobic Gram-negative bacteria resistant to many current treatments for patients.
Emcitate, the first treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome, a rare, chronic and severely debilitating disease caused by mutations in the gene coding for the thyroid hormone transporter MCT8 protein.
Eurneffy, the first nasal spray emergency treatment against allergic reactions, providing an alternative to traditional injections.
Fabhalta, an oral treatment for adults with paroxysmal nocturnal haemoglobinuria, a rare genetic disorder and potentially life-threatening blood disease leading to the premature destruction of red blood cells by the immune system.
Ixchiq, the EU's first Chikungunya vaccine for adults. Chikungunya is endemic in many (sub)tropical countries and causes recurrent epidemics. Due to climate change, it may also spread to regions so far spared. Ixchiq was assessed under EMA's OPEN initiative that fosters international collaboration and the sharing of scientific expertise to promote global public health.
Qalsody, a new therapy for the treatment of adult patients with amyotrophic lateral sclerosis (ALS), a rare and often fatal disease that causes muscles to become weak and leads to paralysis. This medicine is indicated for the treatment of adults with ALS, who have a mutation in the superoxide dismutase 1 (SOD1) gene.
Leqembi, a treatment of mild cognitive impairment (memory and thinking problems) or mild dementia due to Alzheimer's disease (early Alzheimer's disease) in patients who have only one or no copy of ApoE4, a certain form of the gene for the protein apolipoprotein E.
Voydeya, the first oral treatment against residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria.
Welireg, for the treatment of tumours associated with von Hippel-Lindau disease and advanced clear cell renal cell carcinoma. This is the first medicine to treat von Hippel-Lindau disease, a rare genetic disorder causing cysts and tumours.
Winrevair, a treatment for adults with pulmonary arterial hypertension, a rare, long-term, debilitating and life-threatening condition in which patients have abnormally high blood pressure in the arteries in the lungs.
Early access to medicines that address public health needs
In 2024, three medicines received a recommendation for marketing authorisation following an accelerated assessment: Emblaveo, Ixchiq and Kavigale. This mechanism is reserved for medicines that address unmet medical needs. It allows for faster assessment of eligible medicines by EMA's scientific committees (within a maximum of 150 days rather than 210 days).
Eight medicines received a recommendation for a conditional marketing authorisation , one of the possibilities in the EU to give patients early access to new medicines: Augtyro, Beqvez, Filspari, Incellipan, Iqirvo, Ordspono, Seladelpar Gilead and Welireg .
The conditional authorisation allows for early approval on the basis of less complete clinical data than normally required, because the benefit of earlier patient access weighs out the potential risks of limited data. These authorisations come with specific post-authorisation obligations to generate complete data on the medicines and are subject to annual re-evaluation of benefit-risk.
Four medicines (Adzynma, Gohibic, Kayfanda and Qalsody) were authorised under exceptional circumstances, a route that allows patients access to medicines that cannot be approved under a standard authorisation as comprehensive data cannot be obtained, either because there are only very few patients with the disease, or the collection of complete information on the efficacy and safety of the medicine would be unethical. These medicines are subject to specific post-authorisation obligations and monitoring.
The enhanced development support provided by EMA's PRIority Medicines (PRIME) aims at helping patients to benefit as early as possible from promising medicines that target an unmet medical need, by optimising the generation of robust data and enabling accelerated assessment. This year, six medicines with PRIME designation were recommended for approval (Beqvez, Fabhalta, Ixchiq, Seladelpar Gilead, Voydeya and Winrevair).
Fourteen medicines under development were accepted in the scheme in 2024: oncology (5) endocrinology-gynaecology-fertility-metabolism (4), infectious diseases (2), other, congenital, familial and genetic disorders (2) and gastroenterology – hepatology (1).
Consolidation of the Cancer Medicines Pathfinder
In 2024, EMA made substantial progress with its Cancer Medicines Pathfinder initiative. Launched in 2023, this project aims to further support the development and approval of cancer medicines that could have a meaningful impact on transforming patient care. It takes a holistic approach to leverage all areas where EMA's actions can make a difference. Some of the activities included:
Building capacity and enhancing excellence throughout the EU network.
EMA consolidated its Oncology European Specialised Expert Community (ESEC), a platform to promote information sharing among European experts on scientific and regulatory topics. The Agency also launched a multinational pilot programme designed to inform experts outside of EMA and the NCAs about regulatory work and encourage the development of relevant regulatory knowledge to support regulatory activities. It reinforced its engagement with the US Food and Drug Administration (US FDA) in the area of oncology, notably by participating as an observer in Project Orbis, US FDA's framework for concurrent submission and review of oncology products, and by increasing information exchanges. In addition, EMA implemented a comprehensive communication strategy, which included the launch of a dedicated cancer newsletter, in partnership with a national regulator, the German BfArM, to raise awareness and disseminate information among stakeholders.
Improving the efficiency of the centralised procedure.
EMA established a focus group with industry representatives to pinpoint areas for improvement. Areas for actions included enhancing communication flows during the assessment process and accelerating responses from companies when questions arose during the assessment.
Addressing the complexity of approval and access decisions.
Through the Cancer Medicines Forum, established in 2022 in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC), EMA continued to facilitate discussions between academics, healthcare professionals, patients and regulators on how to optimise treatments with oncology medicines.
EMA is also looking to apply the knowledge gained from their experience with cancer to advance the assessment of medicines in other therapeutic areas.
Medicines for rare diseases
The EU framework for orphan medicines encourages the development and marketing of medicines for patients with rare diseases by providing incentives for developers.
Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine's orphan status and granting the medicine ten years of market exclusivity. Among the 114 medicines recommended for marketing authorisation in 2024, 15 had their orphan designation confirmed by the end of the year.
Six medicines lost their orphan status before receiving a marketing authorisation, which means they were still authorised as medicinal products but not as orphan medicinal products. These are: Agilus, Andembry, Beyonttra, Hympavzi, Ordspono and Wainzua.
New uses for existing medicines
In 2024, 90 extensions of indication were recommended, including 40 for paediatric use. The extension of use of a medicine already authorised for marketing in the EU can also offer new treatment opportunities for patients. Notable extensions of indication included:
Ofev, for the treatment of progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents from the age of six.
Pegasys, for the treatment of polycythaemia vera and essential thrombocytopenia in adults.
Xromi, for the prevention of vaso-occlusive complications of sickle-cell disease in children from the age of nine months.
EMA provided scientific advice or protocol assistance to applicants during the development of 60 % of the medicines that were granted a positive opinion. The figure increases to 79 % for medicines with new active substances. Early engagement with developers allows EMA to clarify the kind of evidence required to later evaluate a medicine for authorisation. This encourages the generation of more robust data for regulatory assessment, and protects patients from taking part in unnecessary or poorly designed clinical trials.
Negative opinions
The Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for five medicines in 2024 after concluding that the benefits did not outweigh the risks: Cinainu, Kizfizo, Masitinib AB Science, Nezglyal and Syfovre. Detailed information is available for individual products on EMA's website.
92 % of all opinions (positive and negative) were reached by consensus among CHMP members, without divergent opinions.
Expert views:Interview with
Bruno Sepodes
Chair of the CHMP
This has been your first year as CHMP chair. What are some of the major achievements of the committee in 2024?
Overall, 2024 has been a very successful year for the CHMP and the EMRN. We recommended 114 medicines for marketing authorisation, 46 of which had new active substances previously not authorised in the EU. In addition, we introduced several measures to enhance the efficiency of the marketing authorisation review process. These include the implementation of a standard template for clock-stop extension requests and the update of assessment report templates to improve clarity and reduce duplication. We also provided better guidance and training for assessors to ensure consistency and efficiency. Automatic email notifications to marketing authorisation holders were also introduced to improve the predictability of post-marketing activities. Furthermore, we fostered closer dialogue with applicants to address challenges such as the low predictability of submission dates and the high percentage of companies requesting more time to respond to the committee's questions due to immature data in their applications. All these initiatives aim to accelerate the availability of safe and effective treatments for patients in Europe.
What are some of the main challenges that the committee is facing in 2025?
Staying ahead of scientific progress to ensure robust assessments is a top priority. We need the right expertise to deal with innovation from new directions, such as the use of new methodologies, AI, dealing with increasingly large data sets and integrating them in a meaningful way in the CHMP's assessment. We will continue to invest in training our assessors in cutting-edge areas of drug development. We must also be prepared for the new pharmaceutical legislation, effectively the largest reform of EU medicines regulation in decades. This is a once-in-a-generation opportunity to streamline and improve the medicines regulatory system. We are discussing legislative proposals and are committed to finding efficient solutions that will further improve our work.
Another upcoming challenge for the CHMP will be the implementation of the HTA Regulation and our new responsibilities to provide information to the Coordination Group responsible for the joint clinical assessment by EU HTAs. This will initially apply to new active substances to treat cancer and to all advanced therapy medicinal products (ATMPs). It will later be expanded to all centrally authorised medicines that are submitted for assessment to EMA with a full dossier.
In 2025 we also hope to consolidate the efficiency gains in the evaluation process of marketing authorisation applications that stem from our review and streamlining of processes. We started this initiative in 2024 and will continue throughout 2025.
How do you see the future of regulatory science?
The development of regulatory science is key to the public health achievements we may expect in the future. Regulatory science developed in partnership with academia and with the pharmaceutical industry will allow a faster knowledge transfer of new technologies and methodologies, and we remain committed to be part of this open and constructive dialogue with stakeholders, with the ultimate goal of bringing better medicines faster to the market. As Chair of the CHMP, I want to reinforce the committee's role as a global reference for regulatory science and innovation by adopting new processes and new technologies, improving the efficiency and effectiveness of regulatory processes, while fostering a culture of innovation to better support the development of innovative and promising therapies. I firmly believe the CHMP has a crucial role to play in ensuring that regulatory science in Europe remains at the forefront of global drug development and patient care. Together with our colleagues at EMA, the CHMP will be instrumental in delivering on the promise of innovative medicines for the benefit of all EU citizens.
Keeping patients safe
Monitoring medicines after their authorisation – Optimising safe and effective use
EMA and the EU Member States continuously monitor the quality, safety
and the benefit-risk balance of authorised medicines when they are
used in real life on the market. This is to optimise how the medicine
is used by patients to achieve its full benefit and to protect them
from avoidable side effects. Regulatory measures range from a change
to the product information to the suspension or withdrawal of a
medicine or recall of a limited number of batches.
Important new safety advice issued in 2024 included:
CAR T-cell medicines
Recommendation on the need for life-long monitoring of secondary malignancies in patients treated with these medicines.
Fluroquinolones
Recommendation to include anxiety, suicidal ideation, panic attack, neuralgia and concentration impairment as potential aspects of fluoroquinolone-induced, long-lasting and disabling adverse drug reactions.
GLP-1 receptor agonists
New measures to minimise the risk of aspiration and pneumonia aspiration in patients who undergo surgery with general anaesthesia or deep sedation.
Hydroxyprogesterone-containing medicines
Recommendation to suspend the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the EU, because of a possible but unconfirmed risk of cancer in people exposed to 17-OHPC in the womb. In addition, the review considered new studies, which showed that 17-OHPC is not effective in preventing premature birth. There are also limited data on its effectiveness in other authorised uses.
Medroxyprogesterone acetate
New measures to minimise the risk of meningioma, a type of brain tumour. The measures include recommendations to not use this medicine in patients who have a meningioma or have had one in the past unless medroxyprogesterone acetate is needed for the treatment of an oncological indication, and monitoring symptoms of meningioma in patients taking high doses of medroxyprogesterone.
Metamizole
Updated warnings to increase awareness of agranulocytosis among patients and healthcare professionals, and facilitate its early detection and diagnosis to minimise the serious outcomes of this serious side effect that can lead to serious or even fatal infections.
Mysimba (naltrexone/bupropion)
Recommendation to strengthen existing advice to minimise the risks from interactions with opioid-containing medicines, such as the opioid painkillers morphine and codeine, other opioids used during surgery, and certain medicines for cough, cold or diarrhoea.
Ocaliva (obeticholic acid)
Recommendation to revoke the conditional marketing authorisation of Ocaliva, a medicine used to treat adults with a rare liver disease known as primary biliary cholangitis, because its benefits are no longer considered to outweigh its risks.
Oxycodone
New warning in a black box added to the existing warning in the patient leaflet stating that oxycodone is an opioid that can cause dependence and/or addiction. Dependence and addiction are important risks of oxycodone and remain of concern in the EU/ EEA.
Paxlovid (nirmatrelvir, ritonavir)
New warning on the co-administration of Paxlovid with certain immunosuppressants with a narrow therapeutic index, such as calcineurin inhibitors (ciclosporin, tacrolimus) and mTOR inhibitors (everolimus, sirolimus), which can result in life-threatening and fatal reactions due to pharmacokinetic interactions as Paxlovid is a strong CYP3A inhibitor.
Reyataz (atazanavir)
New contraindications on the co-administration of Reyataz with encorafenib and ivosidenib, and with carbamazepine, phenobarbital and phenytoin.
Valproate
New precautionary measures for the treatment of male patients with valproate medicines to address a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during the three months before conception.
Veoza (fezolinetant)
New recommendation to conduct liver function tests before and during treatment to minimise the risk of liver injury. Treatment with Veoza should be discontinued in certain cases of transaminase and bilirubin elevations, or if liver enzyme elevations are accompanied by symptoms suggestive of liver injury.
The product information for 401 centrally authorised medicines was updated on the basis of new safety data in 2024. Every year, the Pharmacovigilance Risk Assessment Committee's (PRAC) recommendations on safety warnings are also included in the product information of many thousands of nationally authorised products (NAPs). The revised information helps patients and healthcare professionals to make informed decisions when using or prescribing a specific medicine.
Ensuring integrity of clinical trial conduct and the manufacture and supply of medicines
Regulators ensure that development and manufacturing processes of any medicine marketed in the EU adheres to the standards set by EU legislation.
Medicines tested by Synapse Labs Pvt. Ltd
Based on serious concerns about the data from bioequivalence studies conducted at Synapse Labs Pvt. Ltd, a contract research organisation (CRO) located in Pune, India, the CHMP recommended suspending or not granting the marketing authorisations of a number of generic medicines tested by this CRO. The list of the medicines concerned is available on the EMA website.
Expert views:
Interview with
Ulla Wändel Liminga
Chair of the PRAC
You took on the role of PRAC Chair in the second half of 2024, and you have also been a member for a long time. What are the highlights of the committee's work during this year for you?
In 2024, the Pharmacovigilance Risk Assessment Committee (PRAC) carried out a broad range of activities to monitor the safety of medicines in the EU and issued important safety advice for healthcare professionals and patients.
A notable procedure was the review of secondary T-cell malignancies for CAR T-cell immunotherapies used to treat certain cancers. The committee also reminded healthcare professionals of the important risks, including serious side effects involving the nervous system, tendons, muscles and joints related to the use of fluoroquinolones, a class of antibiotics. GLP-1 receptor agonists, a group of diabetes and weight-loss medicines, were high on the PRAC agenda. We recommended new measures to minimise the risk of aspiration and pneumonia aspiration for people taking these medicines who undergo surgery with general anaesthesia or deep sedation. Another review of these medicines concerned a signal of suicidal ideation and self-injurious ideation, for which the PRAC did not find sufficient evidence for a causal relationship.
We also concluded a number of EU-wide safety reviews (referrals). To note one example: the committee recommended suspending the marketing authorisations of medicines containing 17-hydroxyprogesterone caproate (17-OHPC) because of a possible but unconfirmed risk of cancer in people exposed to this substance in the womb.
There were many more noteworthy recommendations that are described in detail in a separate section of this document. They show the relevance and the breadth of the responsibilities of the PRAC.
What are your priorities and your vision for the future work of the PRAC?
Our key task is the safety monitoring of medicines, and my priority is
the protection of public health and patient safety in the EU through
the work of the committee.
We build on the collective experience of our experts to ensure that the
safety of medicines is constantly monitored and evaluated through appropriate
methods, and that the recommendations issued by the PRAC are proportionate,
robust and timely.
Our focus remains on delivering high-quality scientific assessments and
on reinforcing close collaboration within PRAC, with EMA's other scientific
committees, and with the whole of the EU regulatory network.
How can PRAC adapt to meet emerging challenges in medicine safety?
The principles and elements of pharmacovigilance will remain our North
Star during the safety assessment of medicines. Nevertheless, the pace
of innovation in the pharmaceutical field keeps increasing, which we
have to be aware of and adapt to as needed.
In terms of expertise, we rely on the EU medicines regulatory network,
but I can certainly see the need to ensure that the right skills
continue to be in place and that the network's requirements are
addressed in the long term. Training is therefore an important
activity within our network.
We are also embracing new methods and ways of working. The
availability and use of real-world evidence generated within our
network for decision-making is growing. Furthermore, the use of
machine learning and AI is becoming a reality in the development and
regulation of medicines. EMA and the HMA have a multiannual workplan
on AI, with a vision to enable safe and responsible use of AI for the
benefit of public and animal health. Since pharmacovigilance is one
obvious area for such methods, PRAC follows these developments and
will be involved in drafting guidance that will shape the field in the
years to come.
Veterinary medicines
New medicines to benefit animal health in Europe
In 2024, EMA recommended 25 veterinary medicines for marketing authorisation – the highest number ever. Of these, two had a new active substance that had not previously been authorised in the EU. Among the 25 medicines recommended for marketing authorisation, 14 were vaccines, including seven that had been developed through a biotechnological process. The new biotechnological vaccines include:
Cirbloc M Hyo
For the active immunisation of pigs to reduce viraemia (presence of viruses in the blood), virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection, the severity of lung lesions caused by Mycoplasma hyopneumoniae infection, and to reduce the loss in body weight gain.
Divence IBR Marker Live
For the active immunisation of cattle from 10 weeks of age to reduce virus shedding, hyperthermia (high body temperature) and clinical signs caused by bovine herpesvirus type 1 (BoHV-1).
Divence PENTA
For the active immunisation of cattle from 10 weeks of age to reduce virus shedding, hyperthermia (high body temperature), clinical signs and lung lesions caused by bovine respiratory syncytial virus and parainfluenza virus 3; to reduce virus shedding, hyperthermia and clinical signs caused by infectious bovine rhinotracheitis virus; to reduce viremia (presence of viruses in the blood), hyperthermia and leukopenia (decrease in the number of white blood cells) caused by bovine viral diarrhoea virus 1 and bovine viral diarrhoea virus 2, and virus shedding caused by bovine viral diarrhoea virus 2; and for the active immunisation of heifers and cows to reduce births of persistently infected calves and transplacental infection of bovine viral diarrhoea virus (type 1 and 2).
Divence Tetra
For the active immunisation of cattle against bovine respiratory syncytial virus and parainfluenza-3 virus to reduce virus shedding, hyperthermia (high body temperature), clinical signs and lung lesions, and against bovine viral diarrhoea virus (type 1 and 2) to reduce viremia (presence of viruses in the blood), hyperthermia and leukopenia (decrease in the number of white blood cells) caused by bovine viral diarrhoea virus 1 and bovine viral diarrhoea virus 2, and virus shedding caused by bovine viral diarrhoea virus 2; and for active immunisation of heifers and cows to reduce births of persistently infected calves and transplacental infection of bovine viral diarrhoea virus (type 1 and 2).
Innovax-ND-H5
For the active immunisation of one-day-old chicks or 18-19 day-old embryonated chicken eggs to reduce mortality, clinical signs and virus excretion due to infection with highly pathogenic avian influenza (HPAI) virus of the H5 type.
Porcilis PCV M Hyo ID
For the active immunisation of pigs to reduce viremia (presence of viruses in the blood), virus load in lungs and lymphoid tissues, and faecal virus shedding caused by porcine circovirus type 2 (PCV2) infection and severity of lung lesions caused by Mycoplasma hyopneumoniae infection, and Poulvac Procerta HVT-IBD-ND weight gain during the finishing period in face of infections with PCV2 and/or Mycoplasma hyopneumoniae.
Poulvac Procerta HVT-IBD-ND
For the active immunisation of one-day-old chickens and 18-19 day old embryonated chicken eggs to reduce mortality, clinical signs and lesions caused by Marek's disease (MD) virus; reduce mortality, clinical signs and lesions caused by infectious bursal disease (IBD) virus; and reduce mortality and clinical signs caused by Newcastle disease (ND) virus.
Vaccine platform technologies
EMA certified the first veterinary vaccine platform technology master file (vPTMF) in November 2024. The certified Innovax vPTMF is based on a turkey herpesvirus platform, which is already used in several approved vaccines for chickens. Vaccine platform technologies have a set of core components common to all vaccines based on the same platform. They play an important role in animal and public health preparedness because they can be adapted rapidly, thus speeding up the development and approval of new veterinary vaccines in the EU in response to emerging diseases.
Responding to the threat of avian influenza
In April 2024, EMA's veterinary medicines committee, the CVMP,
recommended a new vaccine against the strains of avian influenza (bird
flu) that were circulating in 2024. Innovax-ND-H5 is authorised for
the active immunisation of one-day-old chicks or 18-19 day-old
embryonated chicken eggs to reduce mortality, clinical signs and virus
excretion due to infection with highly pathogenic avian influenza
virus of the H5 type that was predominant in 2024.
Other bird flu vaccine candidates are at different stages of
development. As part of its preparedness activities, EMA works with
public health authorities in the EU and worldwide to monitor the risk
and prepare to respond in the event of a public health emergency.
Optimising the safe and effective useof veterinary medicines
EMA and EU Member States continuously monitor the quality, safety and efficacy of the veterinary medicines on the market in the EU. The aim is to optimise the safe and effective use of a veterinary medicine, to achieve its full benefit, and to protect animals and users from avoidable adverse effects. If the benefit-risk balance of a veterinary medicine changes, EMA can take regulatory measures that range from an amendment to the product information to the suspension or withdrawal of a medicine. The Agency can also recommend recalling batches of the medicine concerned.
At the end of 2024, the CVMP completed a major revision to the Guideline on the evaluation of the benefit-risk balance of veterinary medicinal products. This guideline provides the high-level framework for assessing the positive effects of a veterinary medicine in relation to any risks posed by the use of that medicine to animal or human health, or to the environment, including any risk of development of antimicrobial resistance.
In the area of pharmacovigilance, a three-year pilot set up jointly between EMA and the HMA on processes supporting veterinary signal management was completed in 2024. A new operational expert group of the CVMP pharmacovigilance working party (PhVWP-V) is consequently being established to support the PhVWP-V in the evaluation of the results and outcomes of signal management, and overall surveillance of veterinary medicinal products in the EU.
Important new safetyadvice issued in 2024
The product information for six medicines was updated based on new safety data. The revised information is expected to help animal owners and healthcare professionals to make informed decisions when using or prescribing a medicine. These included:
AdTab and Credelio
Changes to the product information to include hyperactivity, ataxia (incoordination), muscle tremor, tachypnoea (rapid shallow breathing), pruritus (itching), anorexia (appetite loss) and lethargy as potential side effects in cats. Furthermore, changes to the product information to include bloody diarrhoea, polydipsia (increased thirst), pruritus, inappropriate urination, polyuria (increased urination), and urinary incontinence as potential side effects in dogs.
Eluracat
Changes to the product information to include bradycardia (slow heart rate) and hypotension (low blood pressure) as potential side effects. In addition, a new contraindication to no longer use the product in cats with hypersomatotropism (excessive growth caused by too much growth hormone).
Kexxtone
Suspension of the marketing authorisation of Kexxtone 32.4g continuous-release intraruminal device for cattle (monensin) due to a quality defect which has resulted in cases where cattle regurgitated the device while it still contained monensin tablets. This resulted in increased accidental exposure, including deaths, in non-target species (dogs) and a potential lack of efficacy in cattle. To minimise the risk of exposure to non-target species, all batches of Kexxtone have been recalled from the market.
Librela
Changes to the product information to include ataxia (incoordination) together with proprioceptive ataxia, urinary incontinence, anorexia (often related to a transient reduced appetite) and lethargy as potential side effects.
Profender
Changes to the product information to include diarrhoea, anorexia (loss of appetite), lethargy and behavioural disorders, such as hyperactivity, anxiety and vocalisation as potential side effects.
Strangvac
Changes to the product information to include muscle stiffness around the injection site as a potential side effect and to add information that the majority of injection site swellings exceeding 8cm have been observed in the pectoral muscle.
New safety information for animal healthcare professionals
In 2024, EMA published two direct animal healthcare professional communications (DaHPCs) to inform veterinarians and other animal healthcare professionals about safety issues and the actions they should take. These include:
Kexxtone
32.4g continuous-release intraruminal device for cattle (monensin): marketing authorisation suspension and market recall of all batches; and
Senvelgo(velagliflozin)
Oral solution: known risk of diabetic ketoacidosis (DKA) in cats with diabetes mellitus.
Protecting consumers against medicine residues in food of animal origin
If a medicine is intended to be used in a food-producing animal, it needs to be safe for people to eat the food that comes from this animal. EMA recommends maximum residue limits (MRLs) that reflect the level of residues of a veterinary medicine in food derived from a treated animal that can be considered safe for human consumption. The MRL is established before a medicine can be authorised for food-producing animals in the EU and entered in the annex to Commission Regulation (EU) No 37/2010. In 2024, a positive opinion was adopted recommending MRLs for the following active substance:
Ketoprofen
Establishment of numerical MRLs in all ruminants, porcine and equidae (animals of the horse family).
More information and figures on veterinary medicines are available in Chapter 2.
Expert views:Interview with
Gerrit Johan Schefferlie
Chair of the CVMP
Can you share any particular successes from the past year that you believe will have a lasting impact on animal health in the EU?
In 2024, the CVMP issued the first certificate for a vaccine platform technology master file, a novel concept that facilitates the faster development and availability of veterinary vaccines. Additionally, the CVMP issued a positive opinion for a vaccine for highly pathogenic avian influenza under the provisions for exceptional circumstances – the first such opinion under the new Regulation. These examples demonstrate our ability to respond effectively to the evolving needs of the veterinary field, including during disease outbreaks.
In 2024, how did the CVMP contribute to efforts to combat antimicrobial resistance?
The CVMP, in collaboration with EMA and the Member States, stepped up the collection of data on the use of antimicrobials in animals in the EU, in line with our mandate from the veterinary regulation. This builds on the success of the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project, which was a voluntary initiative. These data will help to determine the trends in use, and identify possible risk factors that could lead to the development of further measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced.
Looking ahead, what are some of the most significant challenges the CVMP anticipates in ensuring the safety and efficacy of veterinary medicines, and how do you plan to address these issues in the coming years? What key developments should stakeholders expect in the near future?
Novel technologies are evolving fast in the veterinary field. The CVMP continues to build its capacity and capability in new areas, including through increasing collaboration with our international partners. Our aim is to continue to enable high quality scientific assessments of dossiers that ensure the authorisation of veterinary medicines with sufficient quality, safety and efficacy.