Below you will find a collection of links to regulatory documents and initiatives related to MedDRA.

United States

In March 2003, the US FDA issued a proposed rule detailing additional amendments to its pre- and postmarketing safety reporting regulations. The rule would require that postmarketing individual case safety reports be coded using MedDRA prior to submission to the agency.

•  Safety Reporting Requirements for Human Drug and Biological Products; Proposed Rule 68. Fed Regist 2003 Mar 14; 50:12405-97

European Union

The European Medicines Agency has required that all serious adverse event reports be submitted electronically, using MedDRA codes, since January 2003.

The European Clinical Trials Directive became effective on 1 May 2004 and established the European Clinical Trials Database, a register of all clinical trials in the Community. This database is interfaced with the EudraVigilance Clinical Trial Module (EVCTM). MedDRA (current or previous version, Lowest Level Terms) is to be used for the reporting of suspected unexpected serious adverse reactions (SUSARs) to the EVCTM.

Postmarketing individual case safety reports (ICSRs) reported to the EudraVigilance Post-Authorisation Module (EVPM) require the use of MedDRA.

In Periodic Safety Update reports (PSURs), the adverse reaction terms are required to be in MedDRA.

In the Summary of Product Characteristics (product labeling), MedDRA is required in the Undesirable Effects section for the presentation of adverse reactions.

The use of standardised MedDRA Queries is recommended in Volume 9A, a guidance specifically related to human pharmacovigilance: "Standardised MedDRA Queries (SMQs) may be used for signal detection and the use of SMQs is recommended in order to retrieve and review cases of interest where signals are identified from adverse reaction databases."

The template for EU Risk Management Plans (EU-RMP) requires that data are coded in MedDRA terms where appropriate. To allow the identified and potential risks to be monitored in the context of suspected adverse reactions reported to EudraVigilance, some elements of the EU-RMP are to be provided in electronic format. This format requires the use of MedDRA for certain data elements; terms and codes are to be provided and various levels of the hierarchy, including SMQs, are permitted.

In the EudraVigilance Data Analysis System, standard query filtering options for analysis can be applied at any level in the MedDRA hierarchy from System Organ Class to Preferred Term level, as well as SMQs.

•  Volume 9A of the Rules Governing Medicinal Products in the European Union: Pharmacovigilance for medicinal products for human use. Final March 2007

•  Detailed guidance on the European clinical trials database (EUDRACT Database) ENTR CT 5 April 2003

•  Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use ENTR CT 3 Revision 2 April 2006

The Japanese Ministry of Health, Labour and Welfare requested adverse event reports in the Japanese version of MedDRA (MedDRA/J) beginning 1 April 2000. Electronic submission of reports using the E2B format became mandatory from October 2003. MedDRA/J is to be used in Periodic Infection Reports and Periodic Safety Reports from 1 April 2004. In addition, MedDRA is to be used for reporting infection terms for medical devices with biologic components.

•  MHLW Notification

Canada

In the Draft Guidance Document for Industry, Reporting Adverse Reactions to Marketed Health Products, it is recommended that MedDRA be used as a standard for the coding of adverse reaction reports.

For the Product Monograph (product labeling), MedDRA is the preferred terminology to describe adverse drug reactions.

Draft Guidance Document for Industry, Reporting Adverse Reactions to Marketed Health Products

Guidance for Industry: Product Monograph Final. October 2003.

E2B

The International Conference on Harmonisation (ICH) has developed a guideline to implement the electronic submission of ICSRS for both pre- and post-approval periods in the three ICH regions (Japan, the EU and the US). This guideline, known as E2B(M), specifies that MedDRA codes be used for the electronic transmission of safety reports.

•  E2B(R3)

Common Technical Document

The ICH has developed a common format for new drug and biologic product applications to regulatory authorities in the three ICH regions. From July 2003, the Common Technical Document (CTD) is mandatory in the EU and Japan, and is highly recommended in the US. In the clinical sections of the application, the guideline states that adverse events should be described with a standard dictionary and that the MedDRA terminology should be used.

•  The Common Technical Document for the Registration of Pharmaceuticals for Human Use. Efficacy-M4E(R1)

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