Common Standards for RIMS

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)