Regulators in the different regions had established their own standards, which differed in data format, content, language, and applied standard terminology (e.g., terminology used for substances, routes of administration, pharmaceutical forms, etc.). The transmission of structured data (especially electronically) does imply the use of controlled vocabularies.īefore the ICH initiative, there was no harmonized standard to document information and data on medicinal products. For example, MedDRA and the harmonization of drug dictionaries are critical in the transmission of the ICSR presented in ICH guideline E2B (Data Elements for Transmission of Individual Case Safety Reports). Like MedDRA, the objective of this project was indeed to support all aspects of pre- and post-approval pharmacovigilance activities as well as communication of regulatory information. Pierre-Louis Lezotre MS, PhD, in International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations, 2014 I-1.2.5.5) Data Elements and Standards for Drug Dictionaries (M5 Guideline) The Lowest Level Terms-66 587 in all-constitute the entry level of the terminology to which reported verbatim information is assigned in the process of coding (2). Finally, the “synonym” level of MedDRA is the Lowest Level Terms (LLTs), which are linked to their “parent” Preferred Terms. The single medical concept level of MedDRA is the Preferred Term (PT), of which there are 18 209 High Level Terms group related Preferred Terms.
Below the High Level Group Terms are High Level Terms (HLTs), which are more specific there are 1688 of these. Linked to the SOCs are more specific groupings called High Level Group Terms (HLGTs), 332 of them. SOC Infections and infestations), or serving a classification purpose (e.g. SOC Eye disorders), or relating to etiology (e.g. At the top are 26 System Organ Classes (SOCs) containing terms for disorders by body system (e.g. MedDRA terms are arranged in a five-tiered multi-axial hierarchy ( Figure 1), which provides increasing specificity as one descends it. ‘Rash excluding photosensitivity’ occurred in 25% of subjects in the simeprevir group and 19% of subjects in the Control group during the first 12 weeks of treatment.” 11 In order to also assess ‘rash’ in the absence of the photosensitivity related Preferred Terms, a new variable termed ‘rash excluding photosensitivity’ was created. FDA observed that “the … term ‘rash’ also includes the MedDRA Preferred Terms that comprise the ‘photosensitivity’ grouped variable. Simple change requests are changes affecting the Preferred Term and Lowest Level Term (LLT) levels of the MedDRA terminology … ll requests will be compared to the currently released version of MedDRA and to changes already accepted for the next release of MedDRA.” 10įDA’s Medical Review for simeprevir reveals the situation where the Sponsor had devised a new Preferred Term (though the Medical Review does not mention if the Sponsor had submitted any change request).
MedDRA’s Subscriber Portfolio describes the change request process as “change requests … allow MedDRA subscribers to affect the … content of the terminology.
MedDRA’s “Term Selection: Points to Consider” describes the Sponsor’s ability to add new terms to the MedDRA dictionary, by way of the change request process: “When a specific medical concept is not represented by a single MedDRA term, consider requesting a new term through the change request process.” 9 Tom Brody, in FDA's Drug Review Process and the Package Label, 2018 b Devising New Preferred Terms