Common Standards for RIMS: Difference between revisions
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== Background == | == Background == | ||
Through a consultative proces an international team is recommending that the | 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 == | == Process Standards == | ||
Latest revision as of 15:09, 6 February 2024
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) |
| Monographs |
| ISO 9001:2015 - Quality Management System Procedures |
| Good Distribution Practices (GDP) |
| ISO 17025:2017 |
| Good Practices For Pharmaceutical Quality Control Laboratories |
| Good Clinical Practice (GCP) |
| Good Manufacturing Practices (GMP) or ICH Q7 |
| Good Practices For Pharmaceutical Microbiology Laboratories |
| Good Review Practices (GRevP) |
| Good Storage Practices (GSP) |
| ICH Q10 |
| Good Pharmacovigilance Practices |
Dictionaries & Knowledge Trees
| International Nonproprietary Names (INN) |
| Anatomical Therapeutic Chemical Index (ATC) |
| WHODrug Global |
| National Drug Code (NDC) |
| The Medical Dictionary for Regulatory Activities (MedDRA) |
| Chemical Abstracts Service (CAS) registry number |
| Unique Ingredient Identifier (UNII) |
| ISO 11238 Substance Identification (SubID) |
| GS1 Standards |
| ISO 11615 Medicinal Product Identification (MPID) |
Data Exchange Standards
| Portable Document Format (PDF) |
| XML |
| Common Technical Document (CTD) |
| E2B - Pharmacovigilance: Individual Case Safety Reports (ICSR) or ISO/HL7 27953-2:2011 |
| Structured Product Labelling (SPL) |
| Fast Healthcare Interoperability Standards (FHIR) |