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Regulatory Roadmap for the development of human medicinal Products (Europe focus)

Just click on the various stages below to reveal the information.


Discovery Research

DESCRIPTION

Scientific investigation of a disease model and potential active candidates to establish possible marketable products.
No formal regulatory requirements exist for scientific research of this type and it must be understood that information gathered at this stage is inadmissible in regulatory filings.

Discovery Research covers the period from target identification to nomination and may be used when clinical studies yield results that require further investigation to:

  • Identify potential candidate drugs (CDs)
  • Perform preliminary safety & formulation tests
  • Confirm pharmacological mode of action (potency & selectivity)
  • Identify potential biomarkers
  • Perform preliminary PK
  • Demonstrate activity in in-vivo and/or in-vitro models

The aim is to select one or more CDs for each target for pre-clinical safety evaluation.

INPUTS

Target drug / Hypothesis
Current medical knowledge

PROCESSES “Non GxP” Research
REGULATIONS

Control of Substances Hazardous to Health (COSHH)
Animals (Scientific Procedures) Act 1986
Home office Licensing of in vivo investigations
Human Tissue Act requirements for in vitro investigations

GUIDANCE

Joint Research Council Guidance for non-regulated research
ISO 9000
ISO 17005
Human Tissue Authority
WHO Guidance for QPBR

OUTPUTS

Identification of Test Articles
Scientific Evidence to support hypothesis
Target identified

RQA Courses/Seminars/eLearning

Implementing Quality Systems in Research Environments

eLearning

RQA Publications  Guidelines for Quality in Non-Regulated Scientic Research
 Quality Systems Workbook