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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

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