Medicines: Good Laboratory Practice
These regulations affect test facilities that conduct non-clinical regulatory studies which are designed to obtain data on the safety of new chemical or biological substances with respect to human and animal health or the environment. The regulations set out the principles that should be adhered to when planning, performing, monitoring, recording, reporting and archiving regulatory studies. In the EU and other parts of the world non-clinical regulatory studies are required for the registration of new chemicals and pharmaceuticals. The GLP regulations provide a quality framework which helps to assure regulatory authorities that the data from these studies can be relied upon for the purposes of risk assessment.
These regulations require that any test facility which conducts regulatory studies must be a member of the UK GLP Compliance Monitoring Programme. Test facilities are assessed and monitored through this programme.
We want to hear your views on what more we can do to deliver a simpler, less bureaucratic and more effective system, increase choice and opportunity, and maintain necessary safeguards and legal protections. You can find the regulations that relate to GLP to the left below.
Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 No 1680
Contain measures regulating the importation and marketing of unlicensed medicinal products for human use in order to minimise the risk of the transmission of Transmissible Spongiform Encephalopathies via those products; and sets out rules on importation or marketing of unlicensed medicinal products for human use.
Good Laboratory Practice Regulations 1999 No 3106
Implements the requirements of Council Directive 87/18/EEC on the harmonisation of legislation on good laboratory practice. Includes measures on principles of GLP, arrangements for enforcing the regulations and setting out procedures for dealing with deviations.
Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004 No 994
Updates the definition of the “principles of good labatory practice”, and clarifies definition of “regulatory study” in the GLP Regulations 1999.
Tell us what you think should happen to these regulations and why, being specific where possible:
- Should we scrap them altogether?
- Could their purpose be achieved in a non-regulatory way (eg through a voluntary code?) How?
- Could they be reformed, simplified or merged? How?
- Can we reduce their bureaucracy through better implementation? How?
- Can we make their enforcement less burdensome? How?
- Should they be left as they are?