Regulatory & Pharma Terminology
Checklists and guidance for regulatory pharmacists, medical translators, and clinical-trial authors working on submissions, ICFs, and labelling across MENA jurisdictions.
What this guide covers
Saudi Arabia, UAE, Jordan — specific terminology requirements per regulatory authority.
Informed Consent Forms, patient-facing text readability (LRA scoring), and harmonised terminology for protocols.
SmPC, PIL, and eCTD terminology alignment with SFDA, EMA, and WHO-ART/MedDRA references.
PharmaCheck — your regulatory companion
PharmaCheck validates pharmaceutical documents (ICFs, SmPCs, PILs, clinical summaries) against your chosen audience (patient, investigator, regulatory) and jurisdiction profile. It flags non-standard terminology and suggests authoritative alternatives sourced from WIPO, ALECSO/Arabterm, and UN corpora.
Jurisdiction-specific examples
SFDA requires Arabic-labelled SmPCs and PILs. PharmaCheck maps English→Arabic using SFDA-published terminological references plus WIPO/Arabterm harmonised terms.
Example: adverse drug reaction → التفاعل الدوائي الضار (Arabterm ★)UAE Ministry of Health accepts both English and Arabic submissions. The terminology standard aligns with WHO-ART and EMA guidelines, with Arabic variants drawn from the Arabterm harmonised corpus.
Example: informed consent → الموافقة المستنيرة (UN Terminology)JFDA mandates Arabic for all patient-facing materials. PharmaCheck cross-references Jordanian pharmacopoeia terms where available and falls back to Arabterm harmonised equivalents.
Example: therapeutic indication → الاستطباب (Arabterm ★)For Egypt (EDA), Morocco (DMP), and other MENA regulators, the ★ Harmonised badge marks terms formally validated by ALECSO — the strongest cross-jurisdiction signal available.
LRA scoring for patient materials
PharmaCheck includes an LRA (Level of Readability for Arabic) score for patient-facing documents. ICFs and PILs targeting a general audience should score ≥ 60. The scoring model accounts for:
- Sentence length and syntactic complexity
- Medical jargon density versus plain-language equivalents
- Diacritic coverage (full vowel marks improve readability)
- Term consistency with the ★ Harmonised corpus