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Regulatory Information
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 should be used throughout, in particular for the Contraindications, Special warnings and precautions, and Undesirable effects sections. 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. The new EU pharmacovigilance legislation (a Directive and a Regulation) came into effect in July 2012. The strengthened legislation is intended to improve patient safety and public health through better prevention, detection and assessment of adverse reactions to medicines. A set of good pharmacovigilance practices (GVP) has been developed to facilitate the performance of pharmacovigilance in the EU. MedDRA is referenced as an internationally agreed ICH standard in various GVP modules. • Volume 9A of the Rules Governing Medicinal Products in the European Union: Pharmacovigilance for medicinal products for human use. Final September 2008. • A Guideline on Summary of Product Characteristics Revision 2 September 2009 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. United States The FDA currently uses MedDRA in several of its internal data systems, including the Adverse Event Reporting System (AERS) and the Vaccine Adverse Event Reporting System (VAERS). The AERS is one of the largest databases of MedDRA coded data in the world. MedDRA is planned for implementation in the FDA Adverse Event Reporting System (FAERS), a new repository with enhanced analytic methods. 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. In August 2009, FDA issued a proposed rule change to its postmarketing safety reporting regulations to require that safety reports be submitted in an electronic format that FDA can process, review, and archive. The proposal to require coding of safety reports with MedDRA is included in the Safety Reporting Proposed Rule described above; any new safety reports required by a safety reporting final rule would be required to be submitted electronically in accordance with the electronic submission rulemaking, if adopted as final. In the 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. · Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products · Guidance for Industry: Product Monograph Final. October 2003. 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.
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