MedDRA (Medical Dictionary for Regulatory Activities)

 

Nukalapati Mishma Jaasu, Dr. Raju Kamaraj, R. Seetharaman

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy,

SRM Institute of Science and Technology, Kattankulathur, -6030203, Kanchipuram, Tamilnadu, India.

 

ABSTRACT:

MedDRA is improved by ICH (international conference on hormonisation). It is defined as clinically validated international terminology for medical products used by regulatory authorities. It is a dictionary of adverse events.  It is classified into 5 levels totaling over 81,000 terms. When compared with the world health organization – adverse reaction terminology (WHO-ART) MedDRA is much larger dictionary. The main purpose of MedDRA is to provide uniform consistent, reliable methodology. Between the process of premarketing to the post marketing MedDRA terminologies are used. ICH recognized the different terminologies at different stages to make easy to analyze data.  MedDRA was developed based on UK earlier version drug regulatory agency. For monitoring, product evaluation, electronic records exchange, communication, and oversight Medical dictionary for regulatory activities (MedDRA) became an important tool. In the MedDRA terms for diseases, signs, indications, medication errors, investigations, some terms for social medical history and some quality term procedures are included. In MedDRA drugs, advanced therapies and some device information was covered. To handle the information regarding clinical about biologics, pharmaceuticals, drug-device combinations and vaccines for entire life span of products MedDRA was created. Hardware or software are not required for MedDRA. specific functional system or version of a functional system is not required. Finally, MedDRA went live in early 1999.

 

 

 

What is Medical Dictionary for Regulatory Activities (MedDRA)?

MedDRA is the terminology for medical products which is utilized by authorities of regulatory and the regulated industry of biopharmaceutical which it is a clinically-validated international medical terminology. Between the process of pre-marketing to post-marketing these terminologies are helpful. (1)

 

INTRODUCTION:

In 1990 the MedDRA was developed based on UK earlier version drug regulatory agency. An international group was developed by ICH.  To maintain and administer the maintenance support service organization(MSSO) has been introduced in Virginia and finally MedDRA was introduced in 1999. For more information, visit the website www.meddra.org.

 

For human medicinal products to share the regulatory information MedDRA is designed. (2)

 

MedDRA is a terminology for medical coding and communication. it is not really a dictionary as it doesn’t define words. In MedDRA drugs, advanced therapies and some device information was covered. In the MedDRA terms for indications, symptoms, diseases, medication errors, investigations, and some terms for social and medical history and some quality term procedures and history about medical are included.

It is classified into 5 levels totaling over 81,000 terms:

335 terms - Higher level group terms (HLGTs)

1,700 terms -Higher level terms (HLTs)

26 Terms-System organ classes (SOCs)

18,800 Terms-Preferred terms(Pts)

68,000 Terms-Lowest level terms(LLTs)

 

MedDRA Overview:

In medical research collaboration is a fundamental pillar. To increase or improve and to analyze the best possible medical products for use of patient teams from around the community of medical come over from the beginning of a drug and to on the market and above. Before general release regulatory authorities review the products. In course of developing medicines created it hard to analyze data and to cross reference. So ICH recognized the different terminologies at different stages. Conversion of data from one terminology to other results in the disadvantages regarding cost time, resources.  To facilitate the exchange of information through standardization in case of this challenges, ICH introduced the MedDRA (Medical dictionary for Regulatory Activities). For monitoring, communication, electronic records exchange, product evaluation, oversight MedDRA became an important tool. To balance the clinical information about biologics, vaccines, pharmaceuticals, and drug-device combinations for whole products life span MedDRA was created.  To reach the help of regulators of drug and the industry of pharmacy it was evaluated. It is a medical terminology which was medically oriented, hierarchical, highly specific, and rigorously maintained terminology. (3)

 

PURPOSE OF MedDRA?

By the support of ICH of scientific use for enrollment of pharmaceuticals for use of human MedDRA was developed. The main purpose is in the safety monitoring of medical products, documentation, registration, through all stages of the cycle development (i.e., from phase of clinical trials to post marketing surveillance) MedDRA was used (4).

 

HISTORY:

In 1990 there was NO standard international medical terminology.

The UK terminology called MEDDDRA in 1993 – was reviewed and amended by the regulatory authorities and industry representatives.

To further develop the terminology ICH M1 expert working groups was formed. version 1.0 of MedDRA as basis for medical terminology was adopted by International conference on harmonisation in October 1994

By pharmaceutical companies and regulatory authorities’ version 1.0 was release for alpha testing in February 1996.

 

MedDRA changed the terminology for for medical dictionary for regulatory activities and International conference on hormonisation agreed to version 2.0 in July 1997.

 

Management board of MedDRA was established by the committee of international conference on hormonisation in the year of 1998 in the month of May.

 

In the year of November 1998 Maintenance and Support Services Organization (MSSO) was engaged to uphold and balance MedDRA by IFPMA as a agent of International conference on hormonisation.

 

In the year of 1999 of January JMO (Japanese Maintenance Organisation) was established.

 

MedDRA Earlier version 2.1 was obtained from the MedDRA maintenance and support service organization and the Japanese version from the JMO in the year of 1999 March. (5)

 

Organisation:

 

(1) MedDRA Management Committee

ICH Steering committee appointed the management committee of MedDRA, which had their overall duty for        instructions of MedDRA, Activities of MedDRA was controlled or regulated by the committee. MSSO  (Maintenance and support service organisation) that acts as a repository, sustainer, improvers and dealer of the MedDRA. EC, EFPIA, MHLW, JPMA, FDA, PhRMA are the ICH six parties which are composed in the management committee, The (MHRA) of the UK, Health Canada and the World health organization. Non –voting observer on the management committee was acted by the IFPMA. (6)

 

(2) Secretariat

In the day-to*day management of ICH secretariat plays a major role in coordinating activities of ICH and providing support to the assembly, working groups and the ICH management committee. Support for the ICH MedDRA management committee also provided by the ICH Secretariat. (7)

 

(3) Maintenance and Support Services Organization

The main key functions of the maintenance and support service organization(MSSO) is to, improve, deal, and withhold MedDRA on behalf of MedDRA users.   The members which are included in the MSSO are

·      In the evaluation or analysis of suggested variations presented by MedDRA operators physicians and support personnel are participated.

·      In extent information of regulatory recording requirements extremely expert, multi-lingual (Chinese, English, French, German, Spanish) trainers of MedDRA with industry experience .

·      To confirm acceptance to the MSSO ISO 9001:2015 certification Dedicated, full-time quality assurance personnel

·      To improve and balance software tools for MedDRA employer’s IT staff

·      To provide oversight and direction project management

 

Utilizing the highest quality standards in the industry The MedDRA Maintainenece support service organization members assure that regular functional method and medical surveys of the MedDRA terminology are done.

 

An extent scope of skill in the Regulatory, Biopharmaceutical, and IT industries possessed by the MSSO team. Educated in Germany, India, UK, U.S and the Spain, internationally focused team with members. With the Japanese Maintenance Organization, the MSSO also has a partnership. (8)

 

(4) Japanese Management Board

Under the international conference on hormonisation (ICH) protection, the JMB oversees the activities of the (Japanese Maintenance Organization) JMO, whose important duties are to balance and spread MedDRA in the language of Japanese and forward the standardized utilization in Japan. The JMB is included of agents from the MHLW/PMDA and the JPMA that are also staff of the committee of MedDRA. (9)

 

(5) JMO (Japanese Maintenance Organization)

To uphold or maintain MedDRA for organizations depends in JMO of japan has been established. To offer Japanese user input into MedDRA and to confirm the content and quality of the MedDRA Japanese version equals the English version JMO works in partnership with the MSSO

 

The JMO plays the below operations:

·      Participation of the MSSO of the international change request review process.

·      Terms of MedDRA and member documentation into Japanese are converted.

·      training of MedDRA (e.g., MedDRA introduction, informative meeting on the updated version) was provided to subscribers of JMO.

·      Allots or divides MedDRA to subscribers of JMO

·       Operator Gang congregations or discussions and Help Desk to subscribers of JMO were provided.

·      For MedDRA information in Japan introduced a web site of JMO that helps as the individual point basis

·      To browse and search MedDRA introduced software tools of Japanese (web-based and desktop)

·      Including with the maintenance support service organization (MSSO) (e.g., CIOMS working groups on SMQs, ICH M1 Points to Consider Working Group) Participates in international MedDRA Working Groups. (10)

 

Quality Controls

Robust maintenance process is a key to MedDRA’s success. The maintenance support service (MSSO) has introduced a QMS (quality management system) that comprises many various audits to help the MedDRA change request process: Reilly

·      The ISO 9001: 2015 is MSSO change request process. With annual independent audits The MSSO maintains this certification conducted by BSi™. International Organization for Standardization (ISO) Developed the ISO 9001:2015 standard is a universally recognized QMS.

·      MSSO conducts the primary procedure and clinical audits on change requisition and answers delivered to members.

·       physician who are external that checks a random sample of change requests handled by the MSSO with that release audits each MedDRA.

·      MSSO’s external system and clinical audits are frequently conducted by the MedDRA management committee.

·      For possible process improvements the outcome of all audits are given to the MedDRA Management Committee and are revised by the MSSO. (11)

 

 

Advantages:

For regulators, industry and other stakeholders including patients, research organizations and health care professionals gives a number of advantages by a single standard terminology.

 

Decrease the need to translate data from one terminology to another and prevents the loss of data and allowing savings in resources.

 

For effective analysis, exchange and decision making single standard terminology is very useful.

 

Throughout the various stages of improvement of a medicinal product consistency of the terminology allows effective cross-reference and analysis of data.

 

CONCLUSION:

It is a clinically certified universal terminology utilized by authorities of regulatory which was introduced by international conference on harmonization(ICH). ICH recognized various terminologies at various stages to make data analyzation easier. MedDRA provides several advantages to stakeholders, regulators, industry and other regulators including patients, healthcare professionals, and research organizations. It is classified into 5 levels of 81,000 terms. Through entire process of regulatory from initial step pre marketing to final step post marketing these terminologies are used. By the MedDRA we can prevent the loss of data and it also help during the analysis of data. It provides uniform consistent and reliable methodology.

 

CONFLICT OF INTEREST:

The authors declare no conflict of interest.

 

ACKNOWLEDGMENT:

Authors want to acknowledge the management of SRM College of Pharmacy, SRM Institute of Science and Technology for their valuable support.

 

REFERENCES:

1.         https://www.slideshare.net/somucology/med-dra-basics

2.         Claudia A. White. A Preliminary Assessment of the Impact of MEDDRA on Adverse Event Reports and Product Labeling. Therapeutic Innovation & Regulatory Science. 1998; 32(2).

3.         https://www.meddra.org/faq/meddra-general

4.         https://www.omicsonline.org/proceedings/workshop-on-meddra-and-who-dd-terminology-30858.html

5.         History/About MedDRA. Available from: URL:  https://www.meddra.org/about-meddra/history

6.         MedDRA Management Committee / Organisation / About MedDRA. Available from: URL: https://www.meddra.org/about-meddra/organisation/management-committee

7.         Secretariat / Organisation of ICH / About ICH. Available from: URL: http://www.ich.org/about/organisation-of-ich/secretariat.html

8.         MedDRA MSSO / Organisation / About MedDRA. Available from: URL:https://www.meddra.org/about-meddra/organisation/msso

9.         Japanese Management Board. Available from: URL:  https://www.meddra.org/about-meddra/organisation/jmb

10.       Japanese Maintenance Organization. Available from: URL:  https://www.meddra.org/about-meddra/organisation/jmo

11.       Quality Controls / About MedDRA. Available from: URL: https://www.meddra.org/about-meddra/quality-control

 

 

 

Accepted on 14.07.2018        © RJPT All right reserved

Research J. Pharm. and Tech 2018; 11(10): 4751-4754.