1. THE WHAT AND WHY OF MedDRA
Samina Qureshi, M.D.
PSI INTERNATIONAL, Inc

2. Medical Dictionary for Regulatory Activities
MedDRA
Medical Dictionary for Regulatory Activities
The drug and biologic Industry uses the terminology in its clinical trial data and safety databases for collection of adverse events.
Clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry through the entire regulatory process, from pre-marketing to post-marketing; and for data entry, retrieval, evaluation and presentation.

3. Safety Reporting Regulations
Postmarketing drugs
Generic drugs
Therapeutic biologics
“Grandfather” drugs (pre 1938)
IND Safety reports, NDA/BLA report

4. FDA Guidance for Industry Premarketing Risk Assessment
“Because individual investigators may use different terms to describe a particular adverse event, FDA recommends that sponsors ensure that each investigator’s verbatim terms are coded to standardized, preferred terms specified in a coding convention or dictionary.  Proper coding allows similar events that were reported using different verbatim language to be appropriately grouped.  Consistent and accurate coding of adverse events allows large amounts of data regarding these events to be analyzed and summarized and maximizes the likelihood that safety signals will be detected…
In general, FDA suggests that sponsors use one coding convention or dictionary (e.g., MedDRA) throughout a clinical program…”

5. FDA Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
“FDA suggests that sponsors initially evaluate a signal generated from postmarketing spontaneous reports through a careful review of the cases and a search for additional cases.  Additional cases could be identified from the sponsor’s global adverse event databases, the published literature, and other available databases, such as FDA’s Adverse Event Reporting System (AERS)…, using thorough database search strategies based on updated coding terminology (e.g., the Medical Dictionary for Regulatory Activities (MedDRA).  When available, FDA recommends that standardized case definitions …”

6. MedDRA
If current trends are followed, this may also be mandated for the tobacco industry. Proactively: Good terminology to compile and analyze health data. Is medically validated and allows consistent, standardized application for capture of both health effects AND Product quality issues. Implementation with internal coding guidelines will leave little room for “soft coding”.

7. Scope: MedDRA Covers... Signs and symptoms Disease Diagnosis
Therapeutic indications
Name and qualitative results of investigations and lab results
Medical, social, family history, and risk factors
Surgical and Medical procedures

8. Applications of MedDRA
To report ADRs/AEs, to capture and present product indications, investigational results and patient history
To aggregate reported terms in medically meaningful groupings for reviewing, analyzing, summarizing and communicating safety data
To enable consistent retrieval of specific cases or medical conditions from a database and to identify their frequencies
To facilitate electronic data exchange

9. MedDRA: Basic Structure
Standardized terminology:
5-level Hierarchy
Multiaxiality
Granularity
Retrieval groupings:
Standardized MedDRA Queries (SMQ)
Basic MedDRA structure is hierarchial and multi-axial, plus a Special Search Category.
MedDRA terminology is grouped in five levels, with the broadest category, called the SOC – System Organ Class - at the top, sequentially broken down into more and more specific categories. This is known as ‘hierarchy’.
A single Preferred term (PT level of terminology) may be found within more than one major top level grouping – this is known as multi-axiality.
Special Search Category section of MedDRA is not used for coding, and was developed after the rest of the dictionary. Special Search Categories are intended for data retrieval. There are currently 13 SSC in MedDRA, for example ‘Anaphylaxis’, ‘Pain”, ‘Oedema, ’etc. Each is an associative grouping of Preferred terms across different MedDRA System Organ Classes; this grouping is indicative of a given medical condition.
Special Search Categories can be created in-house to serve the specific retrieval/analysis needs of a company. The ones contained in MedDRA provide an example of a data retrieval technique with such a granular dictionary. The concept is to cast a wide net to ensure complete data retrieval. Special Search Categories can be created at any MedDRA terminology level.
Outside of the Special Search Categories, the main body of MedDRA cannot be customized in-house.

10. Structure Overview MedDRA (version 19.0)
SOC
System Organ Class 27
HLGT
High Level Group Term
335
HLT
High Level Term
1,732
This slide represents the MedDRA levels.
The top level is the System Organ Class, known as SOC. There are 26 SOCs in MedDRA 6.0 and their number has been constant since the beginning. MedDRA SOCs correspond to the main anatomical/functional body systems – Cardiac Disorder SOC, Endocrine disorder SOC, Gastrointestinal disorder SOC, etc. Among the 26, there is also a ‘General disorder’ SOC, an ‘Infections’ SOC, ‘Investigations’ SOC, ‘Congenital disorders’ SOC, ‘Neoplasms’ SOC, and a ‘Social circumstances’ SOC.
A SOC consists of at least one, but usually more, High level Group Terms, HLGTs, which represent the second level of MedDRA terminology.There are 332 HLGTs in MedDRA 6.0. For example, Immune System Disorders SOC consists of Allergic conditions HLGT, Autoimmune disorders HLGT, Immunodeficiency syndromes HLGT, and Immune disorders NEC HLGT.
A HLGT consists of at least one, but usually more, High Level Terms, known as HLTs. There are 1,682 HLTs in MedDRA 6.0. For example, Allergic conditions HLGT consists of Allergies to foods, additives, drugs, chemicals HLT, Anaphylactic responses HLT, Angioedemas HLT, Allergic conditions NEC HLT, Urticarias HLT, and Atopic disorders HLT.
Both the HLGTs and HLTs are broad groupings of terminology. They are not used directly for coding, but for understanding the meaning of a term from lower levels of terminology. However, HLGTs and HLTs are used directly for data retrieval and data presentation.
An HLT consists of at least one, but usually more, Preferred terms, known as PTs. MedDRA 6.0 contains 16,102 PTs. A Preferred term is a single distinct medical concept. It can represent anything in MedDRA – sign, symptom, lab result, indication, history term. It must be unique – there is no overlap at the PT level.
A Preferred term consists of at least one but usually more Low Level Terms, known as LLTs. There are 49,721 current LLTs in MedDRA 6.0 (and 8,839 non-current LLTs, to be explained later).
A Preferred term is described and defined by its Low level terms. This implies that a LLT belongs to one and only one PT. Low level terms are mainly synonyms of the PT and dialectic and lexicant variants of the PT.
An LLT most closely resembles the original reporter’s words. In some cases, an LLT may represent more clinical information than its corresponding PT, but this information is generally not considered crucial by the regulatory authorities. Thus, regulatory authorities are exchanging information at the PT level. However, pharmaceutical companies are coding at the LLT level.
MedDRA reporting to the Food and Drug Administration in the USA and the Ministry of Health Labor and Welfare in Japan is done at the PT level. However, the European authority, EMEA requires reporting of both the LLT and its corresponding PT term.
Each MedDRA term, on every level, consists of a text string and a unique8-digit numeric identifier.
SMQ
Standard MedDRA Queries PT
Preferred Term
21,920
LLT
Low Level Term
75,818 10 10

11. Structure Overview MedDRA (version 11.1)
SOC
System Organ Class 26
HLGT
High Level Group Term
332
HLT
High Level Term
1,699
This slide represents the MedDRA levels.
The top level is the System Organ Class, known as SOC. There are 26 SOCs in MedDRA 6.0 and their number has been constant since the beginning. MedDRA SOCs correspond to the main anatomical/functional body systems – Cardiac Disorder SOC, Endocrine disorder SOC, Gastrointestinal disorder SOC, etc. Among the 26, there is also a ‘General disorder’ SOC, an ‘Infections’ SOC, ‘Investigations’ SOC, ‘Congenital disorders’ SOC, ‘Neoplasms’ SOC, and a ‘Social circumstances’ SOC.
A SOC consists of at least one, but usually more, High level Group Terms, HLGTs, which represent the second level of MedDRA terminology.There are 332 HLGTs in MedDRA 6.0. For example, Immune System Disorders SOC consists of Allergic conditions HLGT, Autoimmune disorders HLGT, Immunodeficiency syndromes HLGT, and Immune disorders NEC HLGT.
A HLGT consists of at least one, but usually more, High Level Terms, known as HLTs. There are 1,682 HLTs in MedDRA 6.0. For example, Allergic conditions HLGT consists of Allergies to foods, additives, drugs, chemicals HLT, Anaphylactic responses HLT, Angioedemas HLT, Allergic conditions NEC HLT, Urticarias HLT, and Atopic disorders HLT.
Both the HLGTs and HLTs are broad groupings of terminology. They are not used directly for coding, but for understanding the meaning of a term from lower levels of terminology. However, HLGTs and HLTs are used directly for data retrieval and data presentation.
An HLT consists of at least one, but usually more, Preferred terms, known as PTs. MedDRA 6.0 contains 16,102 PTs. A Preferred term is a single distinct medical concept. It can represent anything in MedDRA – sign, symptom, lab result, indication, history term. It must be unique – there is no overlap at the PT level.
A Preferred term consists of at least one but usually more Low Level Terms, known as LLTs. There are 49,721 current LLTs in MedDRA 6.0 (and 8,839 non-current LLTs, to be explained later).
A Preferred term is described and defined by its Low level terms. This implies that a LLT belongs to one and only one PT. Low level terms are mainly synonyms of the PT and dialectic and lexicant variants of the PT.
An LLT most closely resembles the original reporter’s words. In some cases, an LLT may represent more clinical information than its corresponding PT, but this information is generally not considered crucial by the regulatory authorities. Thus, regulatory authorities are exchanging information at the PT level. However, pharmaceutical companies are coding at the LLT level.
MedDRA reporting to the Food and Drug Administration in the USA and the Ministry of Health Labor and Welfare in Japan is done at the PT level. However, the European authority, EMEA requires reporting of both the LLT and its corresponding PT term.
Each MedDRA term, on every level, consists of a text string and a unique8-digit numeric identifier.
SMQ
Standard MedDRA Queries PT
Preferred Term
18,483
67,195
LLT
Low Level Term

12. System Organ Class (SOC)
Top level of hierarchy, the broadest concept of standardized terminology, used for data grouping
SOCs may reflect:
- anatomical functional body systems
- etiology (Infections and infestations SOC),
- purpose (Surgical and medical procedures SOC)

13. 27 System Organ Classes (SOCs)
Blood and lymphatic system disorders
Cardiac disorders
Congenital and familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
General disorders and administration site conditions
Hepato-biliary disorders
Infections and infestations
Immune system disorders
Injury, poisoning and procedural complications
Investigations
Metabolism and nutrition disorders
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Nervous system disorders
Pregnancy, puerperium and perinatal conditions
Product issues
Psychiatric disorders
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders
Musculoskeletal and connective tissue disorders
Skin and subcutaneous tissue disorders
Social circumstances
Surgical and medical procedures
Vascular disorders

14. High Level Group Term (HLGT)
HLGTs are broad levels of terminology directly under a SOC and composed of HLTs
HLGTs group related HLTs by anatomy,
pathology, physiology, etiology or function
HLGTs are used for data retrieval, presentation
and analysis

15. High Level Term (HLT) HLT is directly under the HLGT and above the PT
An HLT groups related PTs by anatomy, pathology,
physiology, etiology or function
The HLT level represents medical entities which are detailed by the distinct, unique concepts expressed by the PTs
HLTs are used for data retrieval, presentation and
analysis

16. Preferred Term (PT) PT is a distinct, unique medical concept
Regulatory authorities exchange information at the PT level
PT is the reporting level to FDA and MHLW,
LLT-PT to EMEA
An identical current LLT exists for every PT
PT (with its component LLTs) may be multiaxial,
associated with more than one SOC

17. Hierarchy SOC-HLGT-HLT-PT
SOC Blood and lymphatic disorders
HLGT White blood cell disorders
HLT Neutropenias
PT Agranulocytosis PT Febrile neutropenia
PT Neutropenia PT Idiopathic neutropenia…

18. Lowest Level Term (LLT)
Verbatim is coded to the closest LLT
An LLT is linked to a single PT (Preferred Term)
LLTs linked to the same PT are:
Lexical variants
Synonyms
British and American spellings
May represent an aggravation of the concept
LLT may be current or non-current
Reporting to EMEA: LLT-PT

19. PT Febrile neutropenia
Hierarchy PT - LLT
PT Febrile neutropenia
PT Neutropenia
This slide is an example of the Hierarchical relationship between a Preferred term and its constituent Low Level Terms.
On the left side is the PT Dizziness. On the right is a listing of the LLTs under the PT Dizziness, in alphabetical order.
The first listed is LLT Dizziness. It is exactly the same as the PT Dizziness; the text string and the unique numeric identifier are identical between the two levels. This represents one of the rules of MedDRA – every PT must have a current LLT which is its exact replica. This rule is intended to facilitate companies which may code at the PT level but need to report at the LLT and PT levels – the captured PT automatically translates into its identical LLT.
Second listed is LLT Dizziness aggravated. As of MedDRA version 6.0, most terms representing an aggravation of a baseline condition exist at an LLT level only, grouped under the PT of the baseline condition.
Third and fourth listed LLTs are preceded with ‘N/C’ meaning non-current. An inadequate Low Level term is never deleted from MedDRA, but may be designated as no longer current. This indicates that the term was active in a prior version of MedDRA, but is no longer an active term, and is not to be used for active coding. The original non-current LLTs were mostly complex terms incorporated from other dictionaries. New non-current LLTs appear from one MedDRA version to the next, as the dictionary undergoes medical clean-up procedures. Only an LLT can be made non-current; however, an inadequate PT may be demoted to its LLT, and as such made non-current, with any of its remaining LLTs re-assigned to different PT(s).
PRI system will not allow for active coding with non-current LLTs- the database will simply not accept these terms since they are not a part of the current MedDRA version. However, existing non-current LLTs are designated as such and displayed in a comprehensive listing of LLTs by any browser.
Several LLTs on the slide represent lexical variants and other synonyms of the PT. LLT Light headedness and LLT Lightheadedness represent lexical variants of each other. LLT Dizzy, LLT Woozy and LLT Felt faint represent synonyms of each other.
Note the LLT Pre-syncope and LLT Presyncope. These two LLTs are an example of the 20% of LLTs which convey more clinical information than the corresponding PT. Thus, these are called ‘quasi-synonyms.’ Pre-syncope is clinically a more severe event than Dizziness. It is precisely to enable capture of this level of specificity that companies code at the LLT level, and that EMEA requires reporting at both the LLT and PT levels.
Also notice that these two LLTs, LLT Pre-syncope and LLT Presyncope, represent lexical variants.

20. Hierarchy PT – LLT example from MedDRA 8.0
PT Dizziness
This slide is an example of the Hierarchical relationship between a Preferred term and its constituent Low Level Terms.
On the left side is the PT Dizziness. On the right is a listing of the LLTs under the PT Dizziness, in alphabetical order.
The first listed is LLT Dizziness. It is exactly the same as the PT Dizziness; the text string and the unique numeric identifier are identical between the two levels. This represents one of the rules of MedDRA – every PT must have a current LLT which is its exact replica. This rule is intended to facilitate companies which may code at the PT level but need to report at the LLT and PT levels – the captured PT automatically translates into its identical LLT.
Second listed is LLT Dizziness aggravated. As of MedDRA version 6.0, most terms representing an aggravation of a baseline condition exist at an LLT level only, grouped under the PT of the baseline condition.
Third and fourth listed LLTs are preceded with ‘N/C’ meaning non-current. An inadequate Low Level term is never deleted from MedDRA, but may be designated as no longer current. This indicates that the term was active in a prior version of MedDRA, but is no longer an active term, and is not to be used for active coding. The original non-current LLTs were mostly complex terms incorporated from other dictionaries. New non-current LLTs appear from one MedDRA version to the next, as the dictionary undergoes medical clean-up procedures. Only an LLT can be made non-current; however, an inadequate PT may be demoted to its LLT, and as such made non-current, with any of its remaining LLTs re-assigned to different PT(s).
PRI system will not allow for active coding with non-current LLTs- the database will simply not accept these terms since they are not a part of the current MedDRA version. However, existing non-current LLTs are designated as such and displayed in a comprehensive listing of LLTs by any browser.
Several LLTs on the slide represent lexical variants and other synonyms of the PT. LLT Light headedness and LLT Lightheadedness represent lexical variants of each other. LLT Dizzy, LLT Woozy and LLT Felt faint represent synonyms of each other.
Note the LLT Pre-syncope and LLT Presyncope. These two LLTs are an example of the 20% of LLTs which convey more clinical information than the corresponding PT. Thus, these are called ‘quasi-synonyms.’ Pre-syncope is clinically a more severe event than Dizziness. It is precisely to enable capture of this level of specificity that companies code at the LLT level, and that EMEA requires reporting at both the LLT and PT levels.
Also notice that these two LLTs, LLT Pre-syncope and LLT Presyncope, represent lexical variants.

21. Hierarchy PT – LLT example from MedDRA 10.1
PT Dizziness
This slide is an example of the Hierarchical relationship between a Preferred term and its constituent Low Level Terms.
On the left side is the PT Dizziness. On the right is a listing of the LLTs under the PT Dizziness, in alphabetical order.
The first listed is LLT Dizziness. It is exactly the same as the PT Dizziness; the text string and the unique numeric identifier are identical between the two levels. This represents one of the rules of MedDRA – every PT must have a current LLT which is its exact replica. This rule is intended to facilitate companies which may code at the PT level but need to report at the LLT and PT levels – the captured PT automatically translates into its identical LLT.
Second listed is LLT Dizziness aggravated. As of MedDRA version 6.0, most terms representing an aggravation of a baseline condition exist at an LLT level only, grouped under the PT of the baseline condition.
Third and fourth listed LLTs are preceded with ‘N/C’ meaning non-current. An inadequate Low Level term is never deleted from MedDRA, but may be designated as no longer current. This indicates that the term was active in a prior version of MedDRA, but is no longer an active term, and is not to be used for active coding. The original non-current LLTs were mostly complex terms incorporated from other dictionaries. New non-current LLTs appear from one MedDRA version to the next, as the dictionary undergoes medical clean-up procedures. Only an LLT can be made non-current; however, an inadequate PT may be demoted to its LLT, and as such made non-current, with any of its remaining LLTs re-assigned to different PT(s).
PRI system will not allow for active coding with non-current LLTs- the database will simply not accept these terms since they are not a part of the current MedDRA version. However, existing non-current LLTs are designated as such and displayed in a comprehensive listing of LLTs by any browser.
Several LLTs on the slide represent lexical variants and other synonyms of the PT. LLT Light headedness and LLT Lightheadedness represent lexical variants of each other. LLT Dizzy, LLT Woozy and LLT Felt faint represent synonyms of each other.
Note the LLT Pre-syncope and LLT Presyncope. These two LLTs are an example of the 20% of LLTs which convey more clinical information than the corresponding PT. Thus, these are called ‘quasi-synonyms.’ Pre-syncope is clinically a more severe event than Dizziness. It is precisely to enable capture of this level of specificity that companies code at the LLT level, and that EMEA requires reporting at both the LLT and PT levels.
Also notice that these two LLTs, LLT Pre-syncope and LLT Presyncope, represent lexical variants.
PT Presyncope

22. MedDRA Multi-axiality
Multi-axiality: the representation of a medical concept in multiple SOCs, depending on its meaning
Allows grouping by different classifications
Allows retrieval and presentation via different data sets
Purpose of Primary SOC
Determines which SOC represents multi-axial PTs in cumulative data outputs
A standard supporting/enabling consistent data presentation for reporting to regulators

23. Multiaxiality – PT Level
2nd SOC
Vascular disorders
10 SOC
Endocrine disorders
2nd SOC
Metabolism and nutrition
disorders
HLGT
Hypothalamus and pituitary
gland disorders
HLGT
Metabolism disorders NEC
HLGT
Vascular hypertensive
disorders
HLT
Anterior pituitary hyperfunction
HLT
Metabolic disorders NEC
HLT
Endocrine and metabolic
secondary hypertension
This is an example of a multi-axial PT Acromegaly and its SOCs. In this case, Endocrine disorders SOC is Primary, the other two are secondaries.
Notice that there is always a single PRIMARY pathway between a PT and a given SOC.
PT Acromegaly
(partial hierarchy display)

24. MedDRA Structure Groupings
Primary SOC: Congenital, familial and genetic disorders
HLGT – Cardiac and vascular disorders congenital
HLT – Cardiac septal defects congenital
PT – Univentricular heart
Secondary SOC: Cardiac disorders
HLGT: Myocardial disorders
HLT: Myocardial disorders NEC
PT – Univentricular heart
SOC Investigations
HLGT – Neurological and special sense investigations
HLT – Ear and labyrinth histopathology procedures
PT – Biopsy ear abnormal
Primary SOC Congenital
HLGT – Cardiac and vascular disorders congenital
HLT – Cardiac septal defects congenital
PT Univentricular heart
(Secondary SOC is Cardiac disorders)

25. Multiaxiality - HLT Level
Primary SOC
Congenital, familial and genetic disorders
2nd SOC
Metabolism and nutrition disorders
HLGT
Inborn errors of metabolism
HLGT
Metabolic and nutritional disorders congenital
This is an actual example from MedDRA.
PT Alcaptonuria is a multi-axial PT. It is grouped under three SOCs, but pictured here is the pathway to only two of these three, to display multi-axiality at the HLT level. Notice that there is a common HLT, Inborn errors of amino acid metabolism, after which the path diverges to two separate HLGTs and two separate SOCs.
Notice that, as with all congenital disorders, alkaptonuria is grouped under the Primary SOC Congenital, familial and genetic disorders.
(The third pathway is to HLT Urinary abnormalities, HLGT Urinary tract signs and symptoms, grouped in the Renal and urinary disorders SOC.).
HLT
Inborn errors of amino acid metabolism
(partial hierarchy display)
PT Alkaptonuria

26. Standardized MedDRA Queries
Standardised MedDRA Queries (SMQs) are groupings of MedDRA terms, ordinarily at the Preferred Term (PT) level that relate to a defined medical condition or area of interest
SMQs are intended to aid in the identification and retrieval of potentially relevant individual case safety reports
Currently in v19.0 there are 101 SMQ’s

27. Examples of SMQs Acute pancreatitis Acute renal failure
Agranulocytosis
Anaphylactic reaction
Angioedema
Anticholinergic syndrome
Asthma/bronchospasm
Cardiac arrhythmias
Cerebrovascular disorders
Depression and suicide/self-injury
Dyslipidaemia
Haematopoietic cytopenias
Haemolytic disorders
Haemorrhages
Hepatic disorders
Hyperglycaemia/new onset diabetes mellitus
Interstitial lung disease
Ischaemic heart disease
Lack of efficacy/effect
Lactic acidosis
Neuroleptic malignant syndrome
Peripheral neuropathy
Retroperitoneal fibrosis
Rhabdomyolysis/myopathy
Severe cutaneous adverse reactions
Shock
Systemic lupus erythematosus
Taste and smell disorders
Torsade de pointes/QT prolongation

28. MedDRA Structure Summary
SOC
HLGT
HLT
SMQ PT
LLT
LLT

29. MedDRA PRODUCT QUALITY COMPLAINTS.

30. SOC Product issues
New (27th) SOC for implementation in MedDRA Version 19.0 (March 2016)
Includes terms relevant for issues with
Product quality
Devices
Manufacturing and quality systems
Supply and distribution
Counterfeit products
Expert Working Group provided input on structure and contents
PSI is part of WG
Change requests for new terms

31. Structure Overview HLT HLT LLT 27th SOC Product issues
HLGT
Product quality, supply, distribution,
manufacturing and quality system issues
HLGT
Device Issues
HLT
13 High Level Terms
HLT
8 High Level Terms PT
Preferred Terms PT
Preferred Terms
This slide represents the MedDRA levels.
The top level is the System Organ Class, known as SOC. There are 26 SOCs in MedDRA 6.0 and their number has been constant since the beginning. MedDRA SOCs correspond to the main anatomical/functional body systems – Cardiac Disorder SOC, Endocrine disorder SOC, Gastrointestinal disorder SOC, etc. Among the 26, there is also a ‘General disorder’ SOC, an ‘Infections’ SOC, ‘Investigations’ SOC, ‘Congenital disorders’ SOC, ‘Neoplasms’ SOC, and a ‘Social circumstances’ SOC.
A SOC consists of at least one, but usually more, High level Group Terms, HLGTs, which represent the second level of MedDRA terminology.There are 332 HLGTs in MedDRA 6.0. For example, Immune System Disorders SOC consists of Allergic conditions HLGT, Autoimmune disorders HLGT, Immunodeficiency syndromes HLGT, and Immune disorders NEC HLGT.
A HLGT consists of at least one, but usually more, High Level Terms, known as HLTs. There are 1,682 HLTs in MedDRA 6.0. For example, Allergic conditions HLGT consists of Allergies to foods, additives, drugs, chemicals HLT, Anaphylactic responses HLT, Angioedemas HLT, Allergic conditions NEC HLT, Urticarias HLT, and Atopic disorders HLT.
Both the HLGTs and HLTs are broad groupings of terminology. They are not used directly for coding, but for understanding the meaning of a term from lower levels of terminology. However, HLGTs and HLTs are used directly for data retrieval and data presentation.
An HLT consists of at least one, but usually more, Preferred terms, known as PTs. MedDRA 6.0 contains 16,102 PTs. A Preferred term is a single distinct medical concept. It can represent anything in MedDRA – sign, symptom, lab result, indication, history term. It must be unique – there is no overlap at the PT level.
A Preferred term consists of at least one but usually more Low Level Terms, known as LLTs. There are 49,721 current LLTs in MedDRA 6.0 (and 8,839 non-current LLTs, to be explained later).
A Preferred term is described and defined by its Low level terms. This implies that a LLT belongs to one and only one PT. Low level terms are mainly synonyms of the PT and dialectic and lexicant variants of the PT.
An LLT most closely resembles the original reporter’s words. In some cases, an LLT may represent more clinical information than its corresponding PT, but this information is generally not considered crucial by the regulatory authorities. Thus, regulatory authorities are exchanging information at the PT level. However, pharmaceutical companies are coding at the LLT level.
MedDRA reporting to the Food and Drug Administration in the USA and the Ministry of Health Labor and Welfare in Japan is done at the PT level. However, the European authority, EMEA requires reporting of both the LLT and its corresponding PT term.
Each MedDRA term, on every level, consists of a text string and a unique8-digit numeric identifier.
LLT
Low Level Terms
LLT
Low Level Terms 31 31

32. HLGT: Product quality, supply, distribution, manufacturing and quality system issues
HLT’s
Counterfeit, falsified and substandard products
Manufacturing facilities and equipment issues
Manufacturing issues NEC
Manufacturing laboratory controls issues
Manufacturing materials issues
Manufacturing production issues
Product contamination and sterility issues
Product distribution and storage issues
Product label issues
Product packaging issues
Product physical issues
Product quality issues NEC
Product supply and availability issues

33. HLGT: Device issues HLT’s Device computer issues
Device electrical issues
Device incompatibility issues
Device information output issues
Device issues NEC
Device malfunction events NEC
Device operational issues NEC
Device physical property and chemical issues

34. HLT: Product physical issues
PT’s
Liquid product physical issue
Product coating issue
Product colour issue
Product deposit
Product dosage form issue
Product friable
Product gel formation
Product odour abnormal
Product physical consistency issue
Product physical issue
Product reconstitution issue
Product shape issue
Product size issue
Product solubility abnormal
Product taste abnormal

35. HLT: Product quality issues NEC
PT’s
Product adhesion issue
Product compounding quality issue
Product difficult to remove
Product difficult to swallow
Product formulation issue
Product impurity
Product measured potency issue
Product origin unknown
Product origin unknown
Product process control issue
Product quality control issue
Product quality issue
Product substitution issue
Product tampering

36. Advantages
Use of standardized terminology for product quality issues will facilitate data exchange
Potential uses of product quality terms, including manufacturing and distribution issues
Reporting product defects to regulatory authorities
Track and trend quality issues or deviations in own internal databases
Potential cost savings to utilize same terminology

37. Trending Capability of Product health data at Preferred Term (PT) level

38. Trending Capability of Product health data at System Organ Class (SOC) level

39. Trending Capability of Product quality data at Preferred Term (PT) level

40. MedDRA
Proactively: Good terminology to compile and analyze health data
Is medically validated and allows consistent, standardized application for capture of both health effects AND Product quality issues.

41. Thank you
MedDRA
MedDRA
MedDRA