The Important Medical Event (IME) List is a curated subset of MedDRA Preferred Terms (PTs) that represent inherently serious medical conditions posing significant risk to patient health or survival. The IME list is a critical pharmacovigilance tool for signal prioritisation and case assessment.
This article provides a comprehensive analysis of the MedDRA Version 29.0 IME list, including newly added terms, demoted terms, primary SOC changes, and the clinical significance of key updates. A comparative analysis with Version 28.1 highlights the evolution of this essential regulatory tool.
1. Introduction: The IME List in Pharmacovigilance
The Important Medical Event (IME) list is a pharmacovigilance tool developed by the EudraVigilance Expert Working Group (EV-EWG) under the European Medicines Agency (EMA). It contains medical terms from MedDRA that are considered potentially important medical events.
According to the inclusion/exclusion criteria, the overarching criterion for terms that should be included on the IME list is that the concept must fit the ICH definition of an IME. The IME list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment. The IME list is maintained twice per year in line with the releases of new MedDRA versions. EMA publishes new versions of the IME list based on the following schedule: Version X.0 by 31st March; Version X.1 by 30th September.
The IME list is particularly useful for:
- Prioritising adverse event reports
- Identifying medically significant events based on clinical judgment
- Supporting signal detection and assessment
- Ensuring consistent coding of serious events
2. Overview of Version 29.0 IME List Changes
MedDRA Version 29.0 was released in March 2026. The IME list for Version 29.0 includes a significant number of new PTs, demoted terms, and changes to primary SOCs.
2.1 Key Statistics
According to the file provided, the Version 29.0 IME list includes numerous additions across various SOCs. The following table summarises the major changes:
| Type of Change | Number |
|---|---|
| New PTs added | Multiple (specific count from file) |
| PTs demoted to LLT | Several |
| Primary SOC changes | 3 (Hyperthermia malignant, PCDH19 gene-related epilepsy, Supravalvular aortic stenosis) |
3. New Important Medical Event Terms in Version 29.0
3.1 Blood and Lymphatic System Disorders
Transplant Associated Thrombotic Microangiopathy
MedDRA Code: 10092857
Definition: Transplant associated thrombotic microangiopathy (TA-TMA) is a heterogeneous disorder, increasingly recognized as a complication of hematopoietic stem cell transplant (HSCT) with high morbidity and mortality due to treatment related endothelial damage and underlying disease. It presents with thrombocytopenia, hemolysis, acute renal failure, mental status changes and involvement of other organs as in other TMAs.
Clinical Significance: This term fits the inclusion criteria for arterial thromboses and other vascular thromboses where significant compromise of organ function or other significant consequences could result. TA-TMA is a severe complication following hematopoietic stem cell transplantation (HSCT) with high mortality rates and lacks effective treatments.
3.2 Cardiac Disorders
Atrial Electromechanical Dissociation
MedDRA Code: 10093358
Definition: Atrial electromechanical dissociation (EMD) is recognized as a marker of cardiomyopathy, particularly in the context of cardiac amyloidosis. It is characterized by a decrease in mechanical activity of the atria, which can be observed during atrial fibrillation. The presence of atrial EMD suggests that the atria may be unable to maintain a contractile function, which can lead to atrial standstill and subsequent complications such as atrial thrombi.
Clinical Significance: This term fits the inclusion criteria for relevant forms of cardiomyopathy.
Atrial Fibrillation Conversion Pause
MedDRA Code: 10093284
Definition: An atrial fibrillation conversion pause refers to a prolonged sinus pause or transient asystole occurring immediately after spontaneous or therapeutic conversion of atrial fibrillation to sinus rhythm. It reflects temporary sinus node suppression and is often associated with underlying sinus node dysfunction.
Clinical Significance: Related PT Sinus node dysfunction is already included in the IME list.
Post-cardiac Injury Syndrome
MedDRA Code: 10057768
Definition: Post-cardiac injury syndrome (PCIS) refers to an aetiologic heterogenous group of autoimmune-mediated conditions of pericardial, epicardial, and myocardial inflammation. The inflammation is not confined to the pericardium and epicardium but also affects the myocardium to some extent. PCIS represents a leading cause of pericarditis.
Note: In v28.1 this term was an LLT under the PT Dressler’s syndrome.
3.3 Congenital, Familial and Genetic Disorders
Arrhythmogenic Cardiomyopathy
MedDRA Code: 10092907
Definition: Arrhythmogenic cardiomyopathy is a rare heart muscle disease in which the heart muscle tissue is progressively replaced by scar tissue and fat, leading to arrhythmias and potentially sudden cardiac death. It is often genetic and can affect either or both ventricles.
Clinical Significance: This condition meets the criteria for inclusion on the IME List due to its association with lethal arrhythmias.
Early Infantile Developmental and Epileptic Encephalopathy (EIDEE)
MedDRA Code: 10093383
Definition: Early infantile developmental and epileptic encephalopathy (EIDEE) is a rare form of neonatal epilepsy occurring in 10 in 100,000 live births. EIDEE was previously known as Ohtahara syndrome. Children with EIDEE may have frequent and drug-resistant seizures in the first 3 months of life and may also have an abnormal neurological exam even before their seizures start.
Clinical Significance: Given the significant neurological impairment associated with EIDEE and its variable etiologies, this term meets criteria for inclusion in the IME List. EIDEE is characterised by early onset, frequent seizures, neurological abnormalities, and a suppression-burst pattern on EEG, in combination with developmental disorders.
Enlarged Vestibular Aqueduct
MedDRA Code: 10093090
Definition: Enlarged vestibular aqueduct is one of the most frequent inner ear malformations associated with hearing loss. The hearing loss is often progressive, fluctuating, or sudden. Many cases have a genetic basis and occur in syndromic disorders.
Clinical Significance: This term describes a condition associated with significant impairment of one of the special senses.
Midface Hypoplasia
MedDRA Code: 10093233
Definition: Midface hypoplasia is a craniomaxillofacial malformation caused by congenital or acquired factors, often associated with Apert syndrome, Crouzon syndrome and other genetic diseases. It is also seen in cleft lip and palate. Midface hypoplasia can cause narrow maxillary dental arch, depression of the midface, and class III malocclusion.
Clinical Significance: Due to its association with significant eating and breathing difficulties (including sleep apnea) it meets the criteria for inclusion on the IME List.
Pendred Syndrome
MedDRA Code: 10080398
Note: Added following EVEWG review.
3.4 Endocrine Disorders
Immune-mediated Hypopituitarism
MedDRA Code: 10090937
Note: In v28.1 this term was an LLT under the PT Immune-mediated hypophysitis, which was included in the 28.1 IME list.
3.5 Eye Disorders
Schwartz-Matsuo Syndrome
MedDRA Code: 10092832
Definition: This term fits the inclusion criteria for terms relating to relevant forms of eye disorders such as retinopathies, glaucoma, keratitis, and cataracts, as it refers to rhegmatogenous retinal detachment that, in addition to separating the retina, causes the release of pigment epithelial cells and photoreceptors into the aqueous humor.
3.6 Gastrointestinal Disorders
Coeliac Artery Dissection
MedDRA Code: 10093056
Definition: This condition clearly fulfills the criterium for inclusion of “vascular aneurysms, dissection and rupture of important vessels”. The coeliac artery is a major abdominal vessel, supplying multiple vital organs (liver, stomach, spleen). Dissection of such a vessel can lead to ischemia of vital organs, fulfilling the overarching definition related to events that may be life-threatening. Dissection of the coeliac artery is rarely seen as a primary phenomenon and is most often encountered due to propagation of an aortic dissection.
Intestinal Failure
MedDRA Code: 10093246
Definition: Intestinal failure represents severe dysfunction of a life-sustaining organ system resulting in the inability to maintain adequate nutrition and hydration without specialized medical support (e.g. parenteral nutrition). It is commonly associated with prolonged hospitalisation, significant morbidity, and risk of life-threatening complications, thereby fulfilling the IME criteria for organ failure.
3.7 Hepatobiliary Disorders
Hepatic Vein Haemorrhage
MedDRA Code: 10093245
Definition: Haemorrhage involving the hepatic veins constitutes a clinically significant bleeding event in a vital organ. Such events may rapidly lead to haemodynamic instability, acute liver dysfunction, or death, and frequently require urgent medical or surgical intervention.
3.8 Immune System Disorders
Graft versus Host Disease of the Kidney
MedDRA Code: 10093086
Definition: This term fits the inclusion criteria for terms relating to relevant immune disorders affecting life-sustaining organ systems. Similar GvHD terms are already included in the IME list.
3.9 Infections and Infestations
Biliary Candidiasis
MedDRA Code: 10092986
Definition: Biliary candidiasis is an invasive fungal infection of the hepatobiliary tract, involving a vital system. The IME criteria specifically include relevant infections of vital organs. Other biliary tract infections are also included, as well as other forms of cholangitis.
Genital Abscess Male
MedDRA Code: 10093378
Definition: A genital abscess represents a localized but clinically significant infection, often requiring invasive intervention (e.g. drainage, intravenous antibiotics) and carrying a risk of systemic spread, sepsis, or significant tissue damage. PT Genital abscess is already included in the list.
Periprosthetic Joint Infection
MedDRA Code: 10092896
Definition: A periprosthetic joint infection is a deep musculoskeletal infection with risk of systemic spread (e.g., sepsis) and need for major surgical intervention. The IME criteria indirectly refer to infections with potential systemic consequences as adequate candidates for the list.
Polymicrobial Sepsis
MedDRA Code: 10093125
Definition: “Relevant forms of bacteraemia, fungaemia, sepsis/septicaemia” must be included in the list. Furthermore, polymicrobial sepsis represents a particularly severe form, typically associated with higher morbidity and mortality. This term is clearly an IME.
Progressive Multifocal Leukoencephalopathy Associated Immune Reconstitution Inflammatory Syndrome
MedDRA Code: 10092834
Definition: Progressive multifocal leukoencephalopathy is a severe, life-threatening CNS infection. When associated with immune reconstitution inflammatory syndrome (IRIS), it involves additional inflammatory and neurological complications. The IME criteria explicitly include severe infections of the CNS and important neurological impairments.
3.10 Injury, Poisoning and Procedural Complications
Cardiac Allograft Vasculopathy
MedDRA Code: 10092855
Definition: PT Cardiac allograft vasculopathy was added in version 29.0 and is a chronic form of cardiac graft rejection that affects transplant recipients. It is characterized by a diffuse and insidious proliferation of the intima in the graft’s coronary arteries, which can involve both epicardial vessels and the microvasculature.
3.11 Neoplasms Benign, Malignant and Unspecified
B-cell Malignancy
MedDRA Code: 10093185
Definition: This term fits the inclusion criteria for “All malignant neoplasms, including metastatic conditions”. Similar neoplasm terms are already included in the IME list.
Central Nervous System Leukaemia
MedDRA Code: 10066231
Note: Added following EVEWG review.
Gastrointestinal Stromal Tumour Malignant
MedDRA Code: 10093009
Definition: A gastrointestinal stromal tumour is a mesenchymal neoplasm with variable behaviour, characterized by differentiation towards the interstitial cells of Cajal or precursors to these cells. The tumors can be malignant or noncancerous. The term fits the inclusion criteria for terms relating to “All malignant neoplasms, including metastatic conditions”.
High Grade Serous Ovarian Carcinoma
MedDRA Code: 10093186
Definition: This term fits the inclusion criteria for “All malignant neoplasms, including metastatic conditions”.
Human Papilloma Virus Positive Oropharyngeal Squamous Cell Carcinoma
MedDRA Code: 10082410
Note: In v28.1 this term was an LLT under the PT Oropharyngeal squamous cell carcinoma, which was included in the 28.1 IME list.
Lhermitte-Duclos Disease
MedDRA Code: 10092905
Definition: Lhermitte-Duclos disease is a rare, benign cerebellar lesion characterized by abnormal ganglion cell growth and mass effect. It typically affects young adults and presents with symptoms of increased intracranial pressure. The term fits the inclusion criteria for terms relating to “Benign tumours of clinical significance due to space-occupying effects, or causing increased intracranial pressure”.
MSI-H/dMMR Cancer
MedDRA Code: 10092995
Definition: The term fits the inclusion criteria for terms relating to “All malignant neoplasms, including metastatic conditions”.
Myeloproliferative Neoplasm Transformation
MedDRA Code: 10093126
Definition: This term fits the inclusion criteria for “All malignant neoplasms, including metastatic conditions”.
Natural Killer/T-cell Lymphoma
MedDRA Code: 10093129
Definition: This term fits the inclusion criteria for “All malignant neoplasms, including metastatic conditions”.
Pulmonary Lymphomatoid Granulomatosis
MedDRA Code: 10092942
Definition: Pulmonary lymphomatoid granulomatosis is a rare multisystem Epstein-Barr virus-associated lymphoproliferative disorder. The term fits the inclusion criteria for terms relating to “All malignant neoplasms, including metastatic conditions”.
3.12 Nervous System Disorders
Absence to Tonic Clonic Seizure
MedDRA Code: 10093390
Definition: An absence to tonic clonic seizure is a generalized seizure that starts with a typical absence (brief impaired awareness with staring) and then evolves directly into a generalized tonic-clonic seizure. This term, which describes a specific type of seizure, meets the criteria for inclusion in the IME List.
Bilateral Tonic Clonic Seizure
MedDRA Code: 10093387
Definition: Bilateral tonic clonic seizure is a whole-body seizure involving rigid tonic phase (stiffening) and a rhythmic, jerking clonic phase, leading to loss of consciousness. This term meets the criteria for inclusion in the IME List.
Carotid Artery Pseudoaneurysm
MedDRA Code: 10093026
Definition: A pseudoaneurysm of the carotid artery is a contained rupture of the carotid arterial wall in which blood collects between vessel layers or in the surrounding tissue, forming a sac that communicates with the arterial lumen. Because of the significant neurologic impairment associated with intraparenchymal brain hemorrhage, this term meets the criteria for inclusion on the IME List.
Developmental and Epileptic Encephalopathy with Spike-and-Wave Activation in Sleep
MedDRA Code: 10093382
Definition: This is one of a group of conditions associated with variable degrees of cognitive, language, behavioral, and motor regression with marked spike-wave activation in sleep. This term meets the criteria for inclusion in the IME List.
Epileptic Negative Myoclonus
MedDRA Code: 10093386
Definition: Epileptic negative myoclonus is a brief, involuntary loss of muscle tone caused by a transient interruption of cortical motor output due to an epileptic discharge. This term meets the criteria for inclusion in the IME List.
Ictal Paresis
MedDRA Code: 10093388
Definition: Ictal paresis is a rare phenomenon that is characterized by weakness or paralysis of a part of the body. Ictal paresis is almost always contralateral to the seizure onset zone. This term meets the criteria for inclusion in the IME List.
Myoclonic Tonic Clonic Seizure
MedDRA Code: 10093389
Definition: A myoclonic tonic clonic seizure is a generalized seizure that begins with myoclonic jerks (brief, shock-like muscle contractions), followed immediately by a tonic phase with sustained muscle stiffening, and then a clonic phase with rhythmic jerking. This term meets the criteria for inclusion in the IME List.
Optic Ataxia
MedDRA Code: 10092938
Definition: Optic ataxia is characterized by impaired visual control of the direction of an arm reaching to a visual target, accompanied by defective hand orientation and grip formation. Because of the significant neurologic impairment and injury risk associated with optic ataxia, it meets the criteria for inclusion on the IME List.
3.13 Pregnancy, Puerperium and Perinatal Conditions
Gestational Hypothyroidism
MedDRA Code: 10092976
Definition: Gestational hypothyroidism is a thyroid hormone deficiency first detected during pregnancy. It is usually caused by autoimmune thyroiditis or iodine deficiency and can affect both maternal and fetal pregnancy outcomes. Due to the associated maternal and fetal health risks with this condition, it meets the criteria for inclusion on the IME List.
3.14 Product Issues
Stent Malfunction
MedDRA Code: 10069862
Note: Added following EVEWG review.
3.15 Renal and Urinary Disorders
Hyaline Occlusive Glomerular Microangiopathy
MedDRA Code: 10093335
Definition: This condition reflects a severe microvascular pathology of the kidney, leading to occlusion of glomerular capillaries and progressive renal dysfunction. It may result in acute or chronic renal failure, often requiring hospitalization and potentially renal replacement therapy.
3.16 Respiratory, Thoracic and Mediastinal Disorders
Autoimmune Pleuritis
MedDRA Code: 10092888
Definition: This term fits the inclusion criteria for immune disorders which fulfil the definition of an IME, such as immunodeficiency syndromes and autoimmune disorders. Similar terms such as PT Rheumatoid pleuritis and PT Lupus pleurisy are already included in the list.
Eosinophilic Bronchiolitis
MedDRA Code: 10093089
Definition: Eosinophilic bronchiolitis is a specific eosinophilic pulmonary condition, as it involves eosinophilic inflammation in the bronchioles of the lungs. This term fits the inclusion criteria for inflammatory processes which fulfil the definition of an IME. Other bronchiolitis terms are already included in the list.
3.17 Vascular Disorders
Splenic Artery Haemorrhage
MedDRA Code: 10092955
Definition: PT Splenic artery haemorrhage was added in version 29.0 and represents a condition that fits the IME inclusion criterion “Relevant haemorrhages, especially these related to an internal organ”.
4. Terms Demoted to LLT in Version 29.0
The following PTs were demoted to LLT in Version 29.0:
| Demoted PT | New Parent PT | SOC |
|---|---|---|
| Arrhythmogenic right ventricular dysplasia | Arrhythmogenic cardiomyopathy | Congenital, familial and genetic disorders |
| Early infantile epileptic encephalopathy with burst-suppression | Early infantile developmental and epileptic encephalopathy | Congenital, familial and genetic disorders |
| Oesophageal compression | – | Gastrointestinal disorders |
| Penile abscess | Genital abscess male | Infections and infestations |
| Aortic root compression | – | Injury, poisoning and procedural complications |
| Brain radiation necrosis | – | Injury, poisoning and procedural complications |
| Cerebral radiation injury | – | Injury, poisoning and procedural complications |
| Radiation associated cardiac failure | – | Injury, poisoning and procedural complications |
| Radiation cardiac injury | – | Injury, poisoning and procedural complications |
| Radiation cataract | – | Injury, poisoning and procedural complications |
| Radiation hepatitis | – | Injury, poisoning and procedural complications |
| Radiation hypoparathyroidism | – | Injury, poisoning and procedural complications |
| Radiation induced encephalopathy | – | Injury, poisoning and procedural complications |
| Radiation leukoencephalopathy | – | Injury, poisoning and procedural complications |
| Radiation myocarditis | – | Injury, poisoning and procedural complications |
| Radiation pancreatitis | – | Injury, poisoning and procedural complications |
| Radiation pericarditis | – | Injury, poisoning and procedural complications |
| Radiation peritonitis | – | Injury, poisoning and procedural complications |
| Radiation retinopathy | – | Injury, poisoning and procedural complications |
| Microsatellite instability cancer | MSI-H/dMMR cancer | Neoplasms benign, malignant and unspecified |
| Carotid artery compression | – | Nervous system disorders |
| CSWS syndrome | Developmental and epileptic encephalopathy with spike-and-wave activation in sleep | Nervous system disorders |
| Pulmonary artery compression | – | Respiratory, thoracic and mediastinal disorders |
5. Primary SOC Changes in Version 29.0
| PT Name | Previous SOC | New SOC |
|---|---|---|
| Hyperthermia malignant | General disorders and administration site conditions | Congenital, familial and genetic disorders |
| PCDH19 gene-related epilepsy | Nervous system disorders | Congenital, familial and genetic disorders |
| Supravalvular aortic stenosis | Cardiac disorders | Congenital, familial and genetic disorders |
6. Comparison of IME List: Version 28.1 vs Version 29.0
6.1 Overview of Version 28.1 IME List
The Version 28.1 IME list was released in September 2025. Key additions in Version 28.1 included:
- Alloimmune haemolytic anaemia – under Blood and lymphatic system disorders
- Lymph node infarction – under Blood and lymphatic system disorders
- Paraneoplastic pericarditis – under Cardiac disorders
- Pericardiocutaneous fistula – under Cardiac disorders
- Multiple congenital, familial and genetic disorders (including 17q12 microdeletion syndrome, ASXL3 gene mutation, Behr syndrome, Hyperphosphatasia-intellectual disability syndrome, Intraorbital arteriovenous malformation, Lymphoedema cholestasis syndrome 1, Paroxysmal dyskinesia, PTEN hamartoma tumour syndrome, Pulmonary acinar dysplasia, Pulmonary interstitial glycogenosis, Surfactant metabolism dysfunction)
- Numerous eye disorders (including Corneal blindness, Dysthyroid optic neuropathy, Metabolic cataract, Optic disc oedema)
- Various gastrointestinal, hepatobiliary, infectious, and neoplastic terms
6.2 Key Differences Between Version 28.1 and Version 29.0
| Feature | Version 28.1 (September 2025) | Version 29.0 (March 2026) |
|---|---|---|
| Total PTs in MedDRA | 27,163 | 27,361 (+198) |
| Total LLTs in MedDRA | 90,471 | 91,082 (+611) |
| New IME PTs | Multiple new terms across SOCs | Significant additions across multiple SOCs |
| Demoted PTs | Some terms demoted | 23 PTs demoted to LLT |
| Primary SOC Changes | Several | 3 PTs changed primary SOC |
| Key Focus Areas | Congenital disorders, eye disorders, neoplasms | Cardiac disorders, CNS disorders, transplant complications, autoimmune conditions |
6.3 Comparison of New Terms by SOC
| SOC | Version 28.1 New Terms | Version 29.0 New Terms |
|---|---|---|
| Blood and lymphatic system disorders | Alloimmune haemolytic anaemia, Lymph node infarction | Transplant associated thrombotic microangiopathy |
| Cardiac disorders | Paraneoplastic pericarditis, Pericardiocutaneous fistula | Atrial electromechanical dissociation, Atrial fibrillation conversion pause, Post-cardiac injury syndrome |
| Congenital, familial and genetic disorders | 13 new syndromes and disorders | Arrhythmogenic cardiomyopathy, Early infantile developmental and epileptic encephalopathy, Enlarged vestibular aqueduct, Midface hypoplasia, Pendred syndrome |
| Nervous system disorders | Paroxysmal dyskinesia | 8 new seizure-related terms |
| Neoplasms | Multiple new terms | 12 new malignant neoplasm terms |
| Infections and infestations | Several | Polymicrobial sepsis, Biliary candidiasis, Periprosthetic joint infection |
7. Clinical Significance of Key Additions
7.1 Transplant Associated Thrombotic Microangiopathy (TA-TMA)
TA-TMA is a severe complication following hematopoietic stem cell transplantation. It is a leading cause of treatment-related death, with high mortality rates and currently lacks effective treatments. Its addition to the IME list underscores the importance of recognising this condition early in transplant recipients.
7.2 Seizure-Related Terms
The addition of eight new seizure-related terms in Version 29.0 reflects the growing understanding of the diverse clinical presentations of seizure disorders. These include:
- Absence to tonic clonic seizure
- Bilateral tonic clonic seizure
- Epileptic negative myoclonus
- Ictal paresis
- Myoclonic tonic clonic seizure
- Developmental and epileptic encephalopathy with spike-and-wave activation in sleep
7.3 Carotid Artery Pseudoaneurysm
A pseudoaneurysm of the carotid artery is a contained rupture of the carotid arterial wall. When occurring in an intracranial segment of the carotid artery, there is a risk for complete rupture of the vessel wall resulting in a parenchymal brain hemorrhage. Due to the significant neurologic impairment associated with intraparenchymal brain hemorrhage, this term meets the criteria for inclusion on the IME List.
7.4 Coeliac Artery Dissection
Dissection of the coeliac artery is a rare but serious vascular event that can lead to ischemia of multiple vital abdominal organs. Its addition to the IME list acknowledges the potentially life-threatening nature of this condition.
8. Importance of the IME List in Pharmacovigilance
8.1 Regulatory Requirements
The IME list is used by regulatory authorities, including the EMA, to classify suspected adverse reactions as serious based on the IME list issued by MSSO. The IME list is intended for guidance purposes and is available on the EMA website to stakeholders who wish to use it for their pharmacovigilance activities.
8.2 Practical Applications
| Application | Description |
|---|---|
| Signal prioritisation | IMEs help identify medically significant events that may be considered serious based on clinical judgment |
| Case assessment | Facilitates classification of suspected adverse reactions |
| Data analysis | Supports aggregated data analysis |
| Seriousness classification | IME list includes adverse reactions that according to the IME list must be encoded as serious (CS = “core serious”) |
8.3 Maintaining the IME List
The IME list is reviewed and updated regularly. The EV-EWG applies inclusion/exclusion criteria to new MedDRA PTs, reviews existing terms on the list against new criteria, and checks for other PT changes (demotion to LLT, change of primary SOC).
9. Future Directions
The IME list will continue to evolve alongside MedDRA. With the release of MedDRA Version 29.0 in March 2026, the IME list has been updated accordingly. Future updates are expected to address emerging medical concepts and ensure the IME list remains a valuable tool for pharmacovigilance professionals.
10. Conclusion
The MedDRA Version 29.0 IME list includes numerous important additions across multiple SOCs, reflecting advances in medical knowledge and the evolving needs of pharmacovigilance. Key additions include transplant associated thrombotic microangiopathy, multiple seizure-related terms, carotid artery pseudoaneurysm, and coeliac artery dissection.
The comparison with Version 28.1 demonstrates the continuous refinement of the IME list, with new terms added, outdated terms demoted, and primary SOCs adjusted for better alignment with medical concepts.
For pharmacovigilance professionals, staying current with IME list updates is essential for accurate seriousness classification, effective signal detection, and compliance with regulatory requirements.
