Background
Through a consultative proces an international team is recommending that the below listed minimum standards are considered for inclusion in an RIMS design.
A thorough report is available in the report "USAID MTaPS and PQM+ Programs. Pathway to Digitalize Regulatory Information Management Systems for National Medicines Regulatory Authorities in Low- and Middle-Income Countries. Submitted to the US Agency for International Development by the USAID PQM+ and MTaPS Programs."
Process Standards
| Good Laboratory Practices (GLP)
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| Monographs
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| ISO 9001:2015 - Quality Management System Procedures
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| Good Distribution Practices (GDP)
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| ISO 17025:2017
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| Good Practices For Pharmaceutical Quality Control Laboratories
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| Good Clinical Practice (GCP)
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| Good Manufacturing Practices (GMP) or ICH Q7
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| Good Practices For Pharmaceutical Microbiology Laboratories
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| Good Review Practices (GRevP)
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| Good Storage Practices (GSP)
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| ICH Q10
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| Good Pharmacovigilance Practices
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Dictionaries & Knowledge Trees
| International Nonproprietary Names (INN)
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| Anatomical Therapeutic Chemical Index (ATC)
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| WHODrug Global
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| National Drug Code (NDC)
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| The Medical Dictionary for Regulatory Activities (MedDRA)
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| Chemical Abstracts Service (CAS) registry number
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| Unique Ingredient Identifier (UNII)
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| ISO 11238 Substance Identification (SubID)
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| GS1 Standards
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| ISO 11615 Medicinal Product Identification (MPID)
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Data Exchange Standards
| Portable Document Format (PDF)
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| XML
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| Common Technical Document (CTD)
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| E2B - Pharmacovigilance: Individual Case Safety Reports (ICSR) or ISO/HL7 27953-2:2011
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| Structured Product Labelling (SPL)
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| Fast Healthcare Interoperability Standards (FHIR)
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