Even before a drug could be tested in a clinical trial, the development process of a drug generally involves three major steps, including discovery, preclinical development, and then clinical trial. The transition from discovery to preclinical development is an ongoing process. The results obtained from toxicology and preliminary pharmacology testing often contribute to candidate selection for a drug. The filing of an Investigational New Drug (IND) sets up a boundary between preclinical development and clinical research of a drug.
Thefollowing international organizations ensure drug safety and efficacy:
● World Health Organization (WHO),
● Pharmaceutical Inspection Co-operation Scheme(PIC/S),
● International Organization for Standardization(ISO),
● International Conference on Harmonization(ICH),
● Parenteral Drug Association (PDA), and
● International Society for PharmaceuticalEngineering (ISPE). Take Best Clinical Research Training
Someof the national regulatory bodies issuing guidelines for drug developmentinclude:
● European Medicines Evaluation Agency (EMEA),Europe
● Food and Drug Administration (FDA), US
● Regulatory Operations and Enforcement Branchof Health Canada (ROEB), Canada
● Pharmaceuticals and Medical Devices Agency(PMDA), Japan
● Medicines and Healthcare products RegulatoryAgency (MHRA), UK
● Brazilian Health Regulatory Agency (ANVISA),Brazil
● Therapeutic Goods Administration (TGA),Australia
● Turkish Medicines and Medical Devices Agency(TMMDA), Turkey
