NHS: Drugs

(asked on 5th February 2021) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps the Government is taking support the (a) Medicines & Healthcare products Regulatory Authority and (b) other relevant regulatory authorities in the (i) EU and (ii) US to collaborate with those developing New Approach Methodologies in support of decisions on (A) the progression of drugs into clinical trials, (B) drug licensing and labelling and (c) providing evidence demonstrating the scientific validity and human clinical relevance of NAM data to regulatory scientists.


Answered by
Nadine Dorries Portrait
Nadine Dorries
This question was answered on 17th February 2021

The Government encourages the development of in vitro methods in place of animal testing and the development and use of new tests and alternative methods to the use of animal tests.

In accordance the Animals (Scientific Procedures) Act 1986, the principle of the ‘3Rs’ - Replacement, Refinement and Reduction - needs to be considered when selecting testing approaches to be used for regulatory testing of human and veterinary medicinal products. The challenge to academia, industry and regulatory scientists is to remain focused on designing nonclinical studies in relevant models, including New Approach Methodologies (NAM), to answer specific questions in time to support clinical decision making and communication of potential risks.

Maintaining effective dialogue among scientists in academia, industry and regulatory agencies during model development, qualification and validation will be essential to address this challenge. The Medicines and Healthcare products Regulatory Agency works closely with the National Centre for the Replacement, Refinement and Reduction of Animals in Research and other regulatory agencies to identify opportunities for the ‘3Rs’.

Reticulating Splines