Jump to content

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

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


Pre-Clinical Testing

DESCRIPTION

Research designed to fulfill the requirements of the non-clinical safety section of the common technical document (ICH M4S). Safety evaluation of candidate Investigational Products (New chemical entities and Biologics), known as test articles, governed by Good Laboratory Practice (GLP).

Pre-clinical testing is performed to GLP and covers pivotal toxicology & safety pharmacology studies. This phase continues once clinical trials have commenced to establish the long term safety of new chemical entities.
Non-clinical evaluation of drug safety usually consists of standard animal toxicology studies. These studies usually include assessment of drug exposure, primarily parent drug plasma concentration. Generally, drug plasma concentration and systemic exposure in the non-clinical studies are compared with systemic exposure in humans to assess the potential risks suggested by non-clinical findings and guide monitoring in clinical trials.

Pre-clinical testing is done to evaluate the properties of a test article to either determine its characteristics or to evaluate the effect that it has upon a test system. This involves both in-vitro and in-vivo testing.
INPUTS Test Articles
PROCESSES

“Non GxP” Research
GLP : Pre-Clinical research

REGULATIONS

Control of Substances Hazardous to Health (COSHH)
Animals (Scientific Procedures) Act 1986
GLP : UK Statutory Instrument 3106 (1999)
GLP : OECD Principles of GLP (1997)
GLP: (Codification Amendments Etc.) Regulations 2004
Home office Licensing of in-vivo investigations
Human Tissue Act requirements for in-vitro investigations

GUIDANCE

ICH Safety Guidelines
OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring
Quality Assurance and GLP
The Roles and Responsibilities of the Study Director in GLP Studies
The Application of the Principles of GLP to Computerised Systems
Medicines regulations
M3(R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals 
MHRA Use of non-GLP compliant facilities for the conduct of study phases
GLP studies can only be run in facilities that are Members of the UK GLP compliance monitoring programme
Human Tissue Authority

OUTPUTS Test Article Safety Reports
RQA Courses/Seminars/eLearning

Professional Development Courses and Seminars

eLearning

RQA Publications

 Roles & Responsibilities of GLP Management

 Hosting an External GLP Inspection

 A Practical Guide to GLP Quality Assurance

 Good Clinical Laboratory Practice (GCLP)

 Good Clinical Practice Regulatory Authority Inspections

 The Role of the Monitor in Veterinary Clinical Studies