The questions and answers below aim to address some of the general questions that visitors to the MedDRA website might have about MedDRA and the MSSO. If you do not find an answer to your question among the FAQs, please contact us for assistance.
- What is MedDRA and how is it used?
MedDRA - the Medical Dictionary for Regulatory Activities - is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding these data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyse data related to the safe use of medical products. MedDRA is used to classify adverse event data from clinical trials; from spontaneous adverse event reports by health care professionals, patients and others; and from other sources of adverse event data.
MedDRA, developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), is continuously enhanced to meet the evolving needs of its users, who include regulators and industry worldwide. ICH has created a governance structure to nurture and protect the integrity of MedDRA. The ICH MedDRA Management Board, appointed by the ICH Steering Committee, has overall responsibility for the direction of MedDRA, and oversees all the activities of the MedDRA Maintenance and Support Services Organization.
- In what format is MedDRA distributed?
The MSSO distributes MedDRA as sets of extended ASCII delimited files for the English and Western European languages. There is a different set of files for each available language. The Chinese, Czech, and Hungarian translations are distributed in UTF-8 format. For detailed information for the file names, data record scheme, and record layout, see the MedDRA Distribution File Format document, which can be downloaded from the MedDRA website. The Japanese translation of MedDRA is distributed by the JMO and has a slightly different file format. Please contact the JMO Help Desk (Info.email@example.com) for more information.
- What are MedDRA's system requirements and how do I load MedDRA onto my system?
MedDRA does not have any specific hardware or software requirements. It does not require any particular operating system or version of an operating system. Because MedDRA is intended to be used on multiple platforms, we do not have specific information on loading MedDRA onto every user's specific system or platform. However, if you'll look at the MedDRA Distribution File Format document that comes with MedDRA, it provides information on the table names, field names and attributes, table joins, etc., which are required to create a relational database (e.g., MS Access ®, MS SQL Server ®, Oracle®), with the distributed MedDRA files.
For assistance loading MedDRA distribution files into the MedDRA Browser, please go to the MedDRA Browsers page.
- What information is needed by users to download MedDRA?
Users may download MedDRA as long as they have their MedDRA ID, Password, and the Unzip password. The MedDRA Help Desk only gives this information to the designated point of contact on the subscription; users are directed to get subscription specific information from their company's point of contact.
- When is MedDRA made available?
The English versions of MedDRA are made available on 1 March and 1 September of each year. Chinese, Czech, Dutch, French, German, Hungarian, Italian, Japanese, Portuguese, and Spanish translations of MedDRA are made available two weeks after the English version, or approximately 15 March and 15 September.
- What is the difference between the MedDRA English version and Japanese version?
The concept and contents of the Japanese version of MedDRA are exactly the same as English. Because of language, culture, and medical practice, differences between the Japanese and English MedDRA versions exist. The Japanese version of MedDRA, like other translations, contains duplicate translations of terms at the LLT level. However, MedDRA Japanese version provides an additional J-currency field to ensure the MedDRA Japanese current terms are flagged as unique. See the Japanese Maintenance Organization page for more information on MedDRA Japanese version currency criteria.
- What is the status of ICD-9 © terms in MedDRA?
Some (but not all) ICD-9 terms were incorporated in the first implementable version of MedDRA (Version 2.1 released in 1999) to support migration of ICD-9 coded data. Since then, updates to ICD-9 terms have not been applied to MedDRA. There are no plans to update the ICD-9 to MedDRA.
One ICD-9 concept can be linked to multiple MedDRA terms at multiple levels. The user needs to be aware that equivalencies between the two (ICD-9 and MedDRA codes) are based on concepts and not string matches.
- What is the relationship between CTCAE and MedDRA?
The National Cancer Institute developed the Common Terminology Criteria for Adverse Events (CTCAE) which is used for adverse event reporting in oncology clinical trials. In May 2009, a major revision of CTCAE was released (CTCAE Version 4.0). This version of CTCAE is MedDRA Version 12.0 compatible at the Adverse Event term level where each CTCAE term is a MedDRA LLT. CTCAE Version 4.0 includes 764 AE terms and 26 'Other, specify' options based on the 27 MedDRA SOCs for reporting text terms not listed in CTCAE. Adverse Event terms in CTCAE Version 4.0 are grouped according to their primary SOC allocation in MedDRA. Since CTCAE Version 4.0 is MedDRA compatible, no mapping is needed between the two terminologies. Please refer to the NCI's Cancer Therapy Evaluation Program website for further information on CTCAE.
- Are there any FDA regulations or policies concerning the use of the primary System Organ Class (SOC) allocation of individual terms for adverse event reporting, for either pre-marketing or post-marketing reports? Is there any documentation to support this directive?
Currently, there are no published FDA regulations or policies concerning the use of the primary System Organ Class (SOC) allocation of individual terms for either pre-marketing or post-marketing adverse event reports. The understanding that MedDRA was built by consensus between regulators and industry representatives means that the establishment of criteria for the primary allocation of Preferred Terms (PTs) was a consensus decision. To see additional MSSO comments concerning the primary SOC allocation, please see the Best Practice Documents under the Support Documentation page.
- Is there an international agreement regarding the order in which MedDRA SOCs should appear on Product Labeling?
There is an agreement to the international order of SOCs, which is included with each MedDRA release and can be found in either the Introductory Guide supporting document (Version Documentation) or in the Intl_ord.asc file.
- Does MedDRA support drug product coding?
Drug and other medical product coding is out of the scope of MedDRA. There are terminologies designed spedifically for coding drugs and chemicals that would assist you in this type of coding.
- On what date does a new MedDRA release need to be implemented?
The MSSO advises a single change-over date when the new version of MedDRA becomes effective; the first Monday of the second month after the release date. Please refer to the MSSO recommendation document for additional information. For the current release change-over date, please see the General Documentation under the Support Documentation page.
- How often should clinical trial data be updated to a new MedDRA version?
There are several options for versioning clinical trial data and organizations should choose which best suits their needs. The various options with their merits and issues are presented in the Best Practice document “MedDRA Implementation and Versioning for Clinical Trials” in the Best Practice Documents section on the Support Documentation page.
- How should MedDRA be cited in publications?
The following are guidelines for the use of MedDRA in publications (e.g., journal articles, web based articles, blogs, etc.):
MedDRA text terms may be used in examples, but the examples need to be limited in size (less than 1000 terms).
It should be cited in the article that MedDRA® the Medical Dictionary for Regulatory Activities terminology is the international medical terminology developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The following acknowledgement statement needs to appear in all articles referencing MedDRA: MedDRA® trademark is owned by IFPMA on behalf of ICH.
If possible, please email copies of articles referencing MedDRA MSSO.
Official repositories such as regulatory databases or clinical trial registries are exempt from these guidelines.
- What are the types of change requests?
A change request is a process used by Commercial, Non-profit/Non-commercial and Regulatory users to suggest an addition, relocation, correction of a MedDRA term, an SMQ change, or a correction to a term translated from English to one of the currently supported languages.
A MedDRA term change request can be either a simple change request or a complex change request.
Simple change requests are any changes at the preferred term (PT) level and below in the MedDRA terminology structure.
Any changes involving the hierarchy, meaning the high level terms (HLT), high level group terms (HLGT), or system organ classes (SOCs), are complex changes to the MedDRA terminology. The MSSO will consider complex changes based on input from MedDRA users or internal analysis.
Complex changes are made once a year.
- Who determines what terms are added to MedDRA?
The addition of terms to MedDRA is driven by the MedDRA user change request process. A term that has been submitted by a user may be added to MedDRA if it meets all of the following criteria: must be within scope of the terminology, unambiguous, medically valid and internationally acceptable by an international panel of MSSO medical personnel, and must have a justification that explains the need for the term.
- How do I request a change to MedDRA?
When you obtain a Commercial, Non-profit/Non-commercial or Regulatory subscription, you will receive a Change Request ID, MedDRA ID, and Password. The Change Request page of the MedDRA website explains how to submit a change request. The method to submit change requests is via the online change request submissions application, WebCR.
- Are there additional resources to help our organisation submit change requests?
- Who may request a change?
The MSSO accepts change requests from anyone with a valid MedDRA Identification Number (MedDRA ID) and Change Request Identification Number (CR ID). The MedDRA ID and CR ID are issued to the subscription point of contact within each organisation. A requester refers to individuals within the organisation, in addition to the subscriber point of contact, with authority to submit change requests. Subscribing organisations may authorise requesters as they see fit.
- When can I expect to receive results of a change request?
The results of submitted MedDRA term change requests should complete in 7 to 10 working days, unless additional research is needed. In these cases the requester will receive notice of this action within the 7 to 10 day timeframe.
Changes submitted immediately after the change request processing phase ends (Freeze date), usually 1 December and 1 June of each year, will be held until processing begins for the next version of MedDRA – approximately one month after the Freeze date.
Complex changes can be submitted anytime, but they are only considered for inclusion into MedDRA once a year.
The MSSO will process SMQ change requests and Translation correction requests as soon as possible, but cannot guarantee a specific completion timeframe due to the nature of these requests.
- How do I check the status or outcome of my change request?
Each request is assigned a unique identifier (called the Change Request or CR Number), which is provided to the requester in both the Receipt Notification and the Final Notification reports e-mailed backed to the submitter. Users may use WebCR to track the progress of the submission, review the history of a term, verify a term in MedDRA, or resubmit a rejected request for reconsideration. Alternatively, users may contact the MSSO Help Desk to determine change request status.
The MSSO sends out a Final Notification report for each set of changes submitted which indicates the outcome of each change request. Each change request is assigned a change request number to identify the specific request. Additionally, users may reference the Downloads / Supplemental Changes page (login required) of the website and conduct a search based on either change request number or on the wording of a term to view requests considered by the MSSO.
- Is there a limit to how many change requests can be submitted?
A Non-profit/Non-commercial, Commercial or Regulatory subscription includes a monthly allocation of 100 change requests, not including translation correction requests. There is no limit for translation correction requests.
Users should be aware of the Freeze Date established for each version of MedDRA and plan to submit change requests accordingly, preferably as early as possible before the Freeze date.
- What is the change request process for the MSSO?
The change request process consists of steps to ensure the change request originates from a valid MedDRA subscriber and is complete. The change request must be unambiguous, within scope, meet guidelines for making change requests to the terminology, and must be medically valid and internationally acceptable.
The MSSO requires that an adequate justification accompany each change request in order to be evaluated by the MSSO medical staff. Adequate justification means including a statement indicating why the term or change proposed is necessary, and may be supported by relevant definitions and other illustrative medical and scientific information. Each proposed change is evaluated by an international panel of medical personnel for incorporation into MedDRA. A series of quality control checks are performed throughout the process before an approved change is accepted into MedDRA.
A change request that fails to meet any of the above criteria will be rejected by the MSSO and notification with a rationale for rejection will be sent to the requester. Rejected change requests will count against your annual/monthly change allocation.
- My company is small, so do my requests to add terms to MedDRA receive the same consideration as a large pharmaceutical company?
Yes. When a change request submission is processed, no identification of the submitter is attached to the submission that could influence or create a bias for the International Medical Officers (IMOs), who must come to a consensus on the disposition of a requested change; each request is determined on an individual basis without regard to the identity of the submitter.
- When a PT or LLT term is changed between MedDRA versions, does the corresponding PT or LLT code change also?
If a PT or LLT term is renamed (only if stringent criteria have been met), the corresponding code remains the same. If a new PT or LLT term is added, then the corresponding code is also new.
- Is there a MedDRA Desktop Browser available for download from the MSSO web?
- I just received the latest release of MedDRA. When can I get the Browser that goes with this version?
The browser versions and MedDRA versions are independent. You do not need a new version of the browser to view a new version of MedDRA.
- How do I load MedDRA files into the MSSO MedDRA Desktop Browser available for download from the MSSO web?
- Can I install the Browser on a network?
- Can I get an enterprise licence for the Browser?
The MSSO MedDRA Desktop Browser can be installed on as many workstations as you would like. There is not a separate enterprise licence. Note that anyone using the MedDRA Desktop Browser to view MedDRA data must be covered by a valid MedDRA subscription.
- I have downloaded the browser but I do not see any data. Where do I get the data to load into the browser?
You need to import MedDRA ASCII files into the browser. If you are not a user, contact the MSSO Help Desk for subscription information. If you are a MedDRA user, please contact your organisation's MedDRA point of contact to access the files.
- I installed the MedDRA Desktop Browser on our corporate network. I have granted security privileges to the directory to certain other users who need access to this browser. However, some people get the message that an invalid MedDRA ID exists. How can this problem be solved?
This was a known problem with running older versions of the browser in certain versions of Windows where the user does not have administrator rights. The current version of the browser solves this problem.
- Is there a MedDRA Web-Based Browser available on the MSSO web?
- Who may access the MedDRA Web-Based Browser?
All current MedDRA users may access the MedDRA Web-Based Browser.
- Do I need a MedDRA ID and password for the MedDRA Web-Based Browser?
Yes, you do. A MedDRA ID and password are provided to your organisation’s MedDRA subscription points of contact(s). Please contact the MSSO Help Desk if you do not know your organisation’s subscription points of contact(s).
- Can more than one user from an organisation be logged on at the same time?
Yes. Multiple users from an organisation can be logged on at the same time.
- Does the MSSO provide training on the MedDRA Web-Based Browser?
Yes, there are three recorded videocasts that can be viewed from this site (see the Training Materials page and choose "Tools"). For the topic titled "MedDRA Web-Based Browser," the videocasts are for demonstrating the original features, demonstrating the new 2.0 enhancements, and unique features of Japanese MedDRA.
- What web browsers are compatible with the MedDRA Web-Based Browser?
The MedDRA Web-Based Browser is compatible with later versions of Internet Explorer, Firefox, Chrome, and Safari. Please make sure the following system requirements are met when using the MedDRA Web-Based Browser:
- Screen Resolution 800X600 display resolution or better
Available Ram 1 GB RAM or better
Pop-ups must be allowed
- Screen Resolution 800X600 display resolution or better
- What are the available languages in the MedDRA Web-Based Browser?
The MedDRA Web-Based Browser contains the following languages and versions:
English (v2.1 thru current) Chinese (v12.1 thru current) if subscribed, as it requires a separate subscription Czech (v10.1 thru current) Dutch (v6.1 thru current) French (v5.0 thru current) German (v5.0 thru current) Hungarian (v14.0 thru current) Italian (v7.1 thru current) Japanese (v2.1 thru current) if subscribed, as it requires a separate subscription Portuguese (v5.0 thru current) Spanish (v5.0 thru current)
- Is the login to the MedDRA Web-Based Browser different from the MedDRA website login?
No. The login information (MedDRA ID and password) needed to access the MedDRA Web-Based Browser is the same as the MedDRA website login.
- Is there a user manual for the MedDRA Web-Based Browser?
Yes, there is an online user manual for the MedDRA Web-Based Browser accessible from the Browsers page on this website. It is also accessible by clicking "User Guide" on the upper right corner of the MedDRA Web-Based Browser.
- What is the EULA?
EULA stands for End User Licence Agreement. The MedDRA user must accept the EULA first in order to proceed and log in to the MedDRA Web-Based Browser.
- How does the new version of MedDRA get loaded in the MedDRA Web-Based Browser?
The new version of English MedDRA will be available to users of the MedDRA Web-Based Browser on 1 March and 1 September. Non-English versions of MedDRA are available in the MedDRA Web-Based Browser on 15 March and 15 September. The user does not have to load any MedDRA data.
- What is MVAT?
MVAT stands for MedDRA Version Analysis Tool. MVAT is a web-based tool designed to assist organisations by comparing any two versions of MedDRA – including non-consecutive versions – to identify changes. MVAT is free to all MedDRA users as part of their subscription. The tool comprises three parts:
- Version Report Generator – Compares any two MedDRA releases to produce an exportable version report specific to those releases
- Data Impact Report – Identifies changes to a specific set of MedDRA terms or MedDRA codes uploaded to MVAT and compares them to any two MedDRA releases
- Search Term Change – Identifies the changes to a single MedDRA term or MedDRA code.
- How does the MVAT Data Impact Report handle my uploaded MedDRA terms?
Data uploaded for use with the Data Impact Report are temporarily stored in the physical memory of the MVAT server. After logging out of the application or, if the application times out because of inactivity (20 minutes), a function executes to erase uploaded data from the server’s memory. The results produced from the Data Impact Report are erased in the same manner. If one closes the browser instead of logging out, data will remain in memory until it is removed by the operating system’s clean up procedure.
- Who may access MVAT?
Any organisation currently subscribing to MedDRA through the MSSO may access MVAT. MVAT is free to all MedDRA users as part of their subscription.
- Does MVAT support non-English languages?
Yes. MVAT supports all MedDRA languages. Users may generate MVAT reports in non-English languages and have the option to switch the MVAT user interface to a supported language.
- Do I need a username and password for MVAT?
Yes, you do. To access MVAT a MedDRA user needs to provide their MedDRA ID and either the subscription password or the Change Request ID (CR ID). This information is provided to your organisation’s MedDRA subscription points of contact. Please contact the MSSO Help Desk if you do not know your organisation’s subscription points of contact.
- Does the MSSO provide training or a user guide for MVAT?
In lieu of training or a user guide, the MSSO has posted a recorded streaming video that explains the features and functionality of MVAT. The video may also be downloaded. Please visit the Tools section of the Training Materials page for the MVAT video.
- What computer platforms is MVAT compatible with?
MVAT is a web-based tool designed to be compatible with the latest versions of the most commonly used internet browsers for PCs and Macs. MVAT may not function properly with older web browsers such as Internet Explorer version 8.0.
- Where do I go if I need help using MVAT?
- How does the new version of MedDRA get loaded into MVAT?
The MSSO will upload new versions of MedDRA into MVAT just before or on the day of the MedDRA release - 1 March and 1 September for English and 15 March and 15 September for the non-English languages. No user action is needed.
- Will the MSSO continue to produce the Version Report?
Yes. The MSSO will continue to produce the Version Report, which identifies changes from the latest MedDRA release with the previous release, and include it with each language download.
- How can I find out which SMQs are in production and which are in development?
- Is there any regulatory requirement to use SMQs for safety assessment?
In the EU, SMQs are mentioned in the Guideline on Good Pharmacovigilance Practices (GVP), Module VII (PSUR) and Module IX (Signal Management) in the context of safety signal analysis and assessment.
- My organisation's system does not have the capability to view SMQs. What tools are available to view the structure and content of SMQs?
There are two browsers available to users to view the structure and content of SMQs. The browsers are available to all MedDRA users as part of their MedDRA subscription.
The MSSO's MedDRA Desktop Browser can be used to view the structure and content of SMQs. From the View menu, select the option Show Standardised MedDRA Queries.
The MedDRA Web-Based Browser also shows the SMQs. Click on the SMQ tab on the upper left corner of the Web-Based Browser window to view and search SMQs.
In addition, the Production SMQ Spreadsheet (an Excel file), which is included in the MedDRA release package, enables users to view SMQs without a browser, and to copy and paste the data.
- How do I submit a change request for SMQs? How are change requests handled?
- My organisation is planning to implement SMQs for the next version of MedDRA. Do you have any advice to assure a smooth transition?
Training – This is an important aspect of SMQ implementation. If a user does not understand the intent of SMQs and how they have been built, they could be misused or the retrieved data could be misinterpreted. Both IT staff and medical staff (safety assessors, medical writers - anyone who queries or interprets safety data) need to get SMQ training.
Documentation – Both the SMQ Introductory Guide and all of the other documentation related to file structure, etc. that come with your organisation's MedDRA subscription should be thoroughly reviewed. Besides having information about the file structure (which is important for implementing SMQs in your system), other documents, such as the SMQ Introductory Guide, have detailed information about each individual SMQ, the way each was constructed, and caveats the user must know when interpreting the retrieved information.
Processes - The MedDRA Data Retrieval and Presentation: Points to Consider document, which can be found on the Support Documentation page, recommends that organisations document their processes for data retrieval and presentation; this should also include the use of SMQs.
- Are continuing education hours/credits available for training courses provided by the MSSO?
MedDRA training has been approved for the following continuing education credits/contact hours:
California Board of Registered Nursing
Coding with MedDRA 8.4 hours MedDRA: Safety Data Analysis and SMQs 8.4 hours
Visit the MedDRA Training Schedule for available classes.
- What are the cancellation and waiting list policies for MedDRA training sessions?
The MSSO reserves the right to cancel training events. The MSSO accepts no responsibility for travel arrangements or any actual or perceived loss due to cancellation of a training event.
There is a high demand for the free sessions and there is often a waiting list. As a courtesy to those on the waiting list, please cancel registrations in a timely fashion. If cancellation notice is not received, the MSSO reserves the right to deny attendance in future sessions. Please contact the MSSO Help Desk to be placed on the waiting list of identified session(s).
- Has my training registration form been received?
- Do I need to be a MedDRA user to attend MedDRA training courses?
Yes, you, or your organisation must be a current MedDRA user to attend free MSSO training courses or webinars.
- What class would a beginning MedDRA coder attend?
The MSSO recommends attending the Coding with MedDRA class. This course offers a comprehensive presentation of MedDRA's structure, coding practices, and hands-on exercises. Please see the Training Offerings page of this website for more information.
- Will I get a certificate?
Certificates of course completion are provided in electronic format to trainees who attend a full session of the face-to-face courses.
- How do I become a MedDRA user?
Click on the Online Subscription page of this website or open the Process page to view the subscription process. After completing and submitting the subscription agreement, the MSSO will send an invoice (if applicable) to your organisation. Please include documentation to support the subscription type (e.g., annual financial report for commercial organisations) if requested. Upon receipt of payment, subscriber information will be provided to the designated point of contact to download MedDRA from the MedDRA site. Users are immediately eligible for services.
- What is the release schedule for MedDRA?
MedDRA is released on 1 March and 1 September. The translations of MedDRA are released on 15 March and 15 September.
- What is the effective period of a MedDRA subscription?
An MSSO subscription is effective for twelve months commencing with the first day of the month following the MSSO's receipt of payment of the subscription invoice.
- How are subscription renewals handled?
Subscription renewal notices are emailed by the MSSO approximately 30-45 days prior to subscription end date. If the MSSO is able to obtain a subscriber's financial information online, an invoice will be automatically emailed in the renewal notice to the billing point of contact on file.
However, if the subscribing company is privately held, a response is required that provides the necessary financial information before the MSSO can invoice for the MedDRA subscription renewal period. Alternatively, the subscription can be renewed by accessing the online renewal form on this website. If the subscriber does not wish to be renewed, notification must be received in writing by the MSSO at least 30 days prior to the subscription end date by emailing the MSSO Help Desk.
- If I subscribe midyear, how many updates of MedDRA will I receive?
The MSSO subscription year will start when payment is received. You will receive one full year of updates based on your subscription timeline. MedDRA updates are bi-annual with the first release in March and the second in September.
- My corporation has purchased a subscription to MedDRA. Can copies be made of MedDRA or can MedDRA be shared with other parts of the company or corporation?
Yes. MedDRA subscriptions are sold on an enterprise-wide basis, not by the number of seats. Your MedDRA subscription may be shared with all employees of your company/organisation and their majority-owned subsidiaries. There is no limit to the number of copies you may make for your company's use. The subscription point of contact listed on the Subscriber Agreement is responsible for determining who may receive copies or share capabilities of MedDRA within the organisation and distributing MedDRA ID, Passwords, Change Request ID, and/or Unzip passwords to those that may need them to access information.
- What is the help desk support level provided to users?
The MSSO Help Desk provides year-round coverage help desk support in English for MSSO users. The help desk will answer questions regarding MedDRA MSSO products and services including but not limited to: subscription information, MedDRA scope and structure, MedDRA versions and release schedules, general terminology questions, User Group information, change request information including maintenance rights, and supplemental terms/changes information.
- In what language is MedDRA available?
MedDRA is available in Chinese, Czech, Dutch, English, French, German, Hungarian, Italian, Japanese, Portuguese, and Spanish to all users via download.
The Japanese translation of MedDRA is an additional fee.
- What are the maintenance rights for users?
The maintenance rights available to Non-profit/Non-commercial and Commercial subscription types are as follows:
- 100 routine change requests per month
- Access to supplemental terms
- Explanation of change request final dispositions
System Developer subscription types cannot submit change requests.
- In what language is Help Desk support available?
MSSO Help Desk support is available in English and Chinese. The Japanese Maintenance Organization has its own Help Desk for MedDRA/J users. The MedDRA/J Help Desk is supported in Japanese. The JMO contact email is Helpdesk.firstname.lastname@example.org.
- Where do I download translations of MedDRA?
- Why must both CRO and a client company have a subscription to MedDRA?
It is the intent of the ICH, the creators of MedDRA, and the IFPMA, the holders of the property rights to MedDRA as trustee of ICH, that all pharmaceutical companies have a current MedDRA licence to code, analyse, report, or hold MedDRA coded data. CROs that code, report, or hold MedDRA coded data must also have a current licence to MedDRA. Otherwise the sharing of data violates the MedDRA licencing agreement created by the IFPMA regarding the distribution of MedDRA to another party. You may also see our Statement on MedDRA Data Sharing. Click on How to Share MedDRA Data on the kiosk of the Subscription Process page.
- I had an Unzip password last version and now it doesn't work. Why not? How can I get a new one?
Unzip passwords are used to access MedDRA internet file downloads for each language as well as SMQs that are in production. Unzip passwords change with each version of MedDRA. They are sent to the designated subscription point of contact (PoC) approximately four weeks prior to the version release to give time to disseminate the information within the organisation to those who need it. Please check with the designated subscription PoC for this information. If you do not know who the PoC is, please contact the MedDRA MSSO Help Desk.
- I subscribe to MedDRA/J. How do I communicate with the Japanese Maintenance Organization (JMO)?
- Who decides how much a MedDRA subscription costs?
Under the governance of the ICH MedDRA Management Board, MedDRA is continuously enhanced to meet the evolving needs of all its users around the world. Sustainability of a high quality terminology needs an income stream, and the ICH MedDRA Board has opted for a licencing model that provides access to the terminology at a fair cost shared by its users through an annual subscription fee.
The ICH MedDRA Board approves the subscription fees on an annual basis and uses the revenues generated by the fees to cover the annual costs of the MedDRA MSSO and MedDRA development activities.
- What is the bank transfer fee reference on the subscription invoice?
If you are making a wire transfer through an international bank, a fee is charged for the transaction. You are required to include that amount in addition to the subscription total on the invoice. Failure to include the appropriate wire fee charge may interrupt the processing of your MedDRA subscription.
- How do I determine if I qualify for a MedDRA EudraVigilance licence fee waiver with the EMA?
- How do I apply for a MedDRA licence fee waiver?
If your organisation qualifies, you do not need to specifically apply for a fee waiver. While registering with EudraVigilance, follow the instructions. For more information, see the EudraVigilance website for How to Register.
If you require further help, please contact the EMA:
EudraVigilance Info Line +44 (0) 20 7523 7523
EudraVigilance e-mail: email@example.com
- What is the relationship between MedDRA and EudraVigilance?
The European Medicines Agency (EMA) provides interested organisations with reporting obligations in pharmacovigilance (pre- and post-authorisation phase) the possibility to use EVWEB, a web-based application, which is an integrated part of the European pharmacovigilance system called EudraVigilance. EVWEB incorporates MedDRA and allows for electronic reporting of ICSRs to the EMA and National Competent Authorities in the EEA in compliance with the applicable ICH standards.
The MedDRA Management Board approved a MedDRA licence fee waiver programme to facilitate the electronic reporting by small and micro organisations and non-commercial sponsors of clinical trials. For details about the MedDRA licence fee waiver see the EudraVigilance web page for MedDRA Licencing Policy.
EVWEB includes the use of MedDRA for reporting ICSRs and SUSARs into the EudraVigilance system. Access to MedDRA through the EVWEB is for online use and cannot be downloaded. EVWEB does not allow for off-line use of MedDRA for creating reports or analysis.
- What is the MedDRA Licence Number that is required by EMA for registration to EMA EudraVigilance for electronic transmissions of ICSRs?
The MedDRA Licence Number referred to by EMA is the organisation's MedDRA ID for its MedDRA subscription.
- Do I first need a MedDRA licence fee waiver to qualify to use the EVWEB system?
If your organisation qualifies for the MedDRA license fee waiver for EudraVigilance, you don't need a MedDRA subscription to use the EVWEB.
If your organisation does not qualify for the MedDRA license fee waiver, yes, you need to purchase a MedDRA subscription in order to use the EVWEB system.
- We are a CRO reporting to EudraVigilance on behalf of multiple pharma companies; do both parties have to have a MedDRA licence in order to use the EVWEB?
The companies that you are representing need to be registered with EudraVigilance. As part of the registration process they will state that you are their third party service provider, and register your details.
As part of the registration process every registering organisation will be asked to provide MedDRA subscription information:
- If the organisation you are representing qualifies for the EudraVigilance MedDRA license fee waiver, they can proceed to finalize registration.
- If the organisation you are representing does not qualify for the EudraVigilance MedDRA license fee waiver, they need to provide their MedDRA licence number, and then proceed to finalise registration.
The organisation for which you are acting as third party service provider has to obtain a MedDRA licence number and provide that number during the registration process with EudraVigilance. Please note that the MedDRA licence number required in the registration form with EudraVigilance is the registering organisation's own, not the MedDRA licence number of any third party provider, such as a CRO.
- What is the User Group Meeting?
MSSO User Group meetings serve as a forum to discuss enhancements to the terminology and propose changes to the services offered by MSSO. In addition, the User Group meetings provide an opportunity for individuals to network with other professionals in the pharmacovigilance community. The User Group meetings are held annually in the US, EU, and China.
- What are the User Group meeting dates and locations?
Visit the MedDRA User Groups page of the MedDRA MSSO website for any scheduled upcoming meetings or to view previous meeting details. In practice, the US and European User Group meetings are held directly after the Drug Information Association "Annual Meeting" and "EuroMeeting" have completed in their respective cities. The Chinese User Group meeting is scheduled at the discretion of the MSSO.
- How can I network with other individuals in the pharmacovigilance community?
The MedDRA User Group meetings, sponsored by the MSSO, serve as a forum for the exchange of best practices and lessons learned among MedDRA users within the industry. We encourage user attendance as well as questions to generate conversations among users at the meetings.
- What is a MedDRA "Blue Ribbon Panel"?
Blue Ribbon Panels (BRPs) have been developed to provide a forum for MedDRA experts from industry and regulatory authorities to discuss and make recommendations on challenging MedDRA issues on behalf of the user community.
BRPs are scheduled when an issue of interest is brought to the attention of the MSSO. Panel members are chosen and BRPs are open to users who wish to attend as audience members.
For further information on BRPs please visit our Blue Ribbon Panel page.