The activity on the M5 Guideline only began in 2003. This lack of internationally harmonized standards related to core sets of medicinal product information and medicinal product terminology made the scientific evaluation, comparison, and exchange of drug data (especially in the area of pharmacovigilance) very difficult. The WHO Drug Dictionary, or a modified version of this product, was sometimes used. 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.Д«efore 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) вЂRash excluding photosensitivityвЂ™ occurred in 25% of subjects in the simeprevir group and 19% of subjects in the Control group during the first 12 weeks of treatment.вЂќ 11 In order to also assess вЂrashвЂ™ in the absence of the photosensitivity related Preferred Terms, a new variable termed вЂrash excluding photosensitivityвЂ™ was created. FDA observed that вЂњthe вЂ¦ term вЂrashвЂ™ also includes the MedDRA Preferred Terms that comprise the вЂphotosensitivityвЂ™ grouped variable. Simple change requests are changes affecting the Preferred Term and Lowest Level Term (LLT) levels of the MedDRA terminology вЂ¦ ll requests will be compared to the currently released version of MedDRA and to changes already accepted for the next release of MedDRA.вЂќ 10ДЇDAвЂ™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). MedDRAвЂ™s Subscriber Portfolio describes the change request process as вЂњchange requests вЂ¦ allow MedDRA subscribers to affect the вЂ¦ content of the terminology. MedDRAвЂ™s вЂњTerm Selection: Points to ConsiderвЂќ describes the SponsorвЂ™s ability to add new terms to the MedDRA dictionary, by way of the change request process: вЂњWhen a specific medical concept is not represented by a single MedDRA term, consider requesting a new term through the change request process.вЂќ 9 Tom Brody, in FDA's Drug Review Process and the Package Label, 2018 b Devising New Preferred Terms

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