20 Apr 2026·Department for Science, Innovation and Technology·Answered
AskedInnovation and Technology, with reference to the policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress she has made on collecting data annually on the number of clinical trial applications that include toxicity tests conducted in 2 species.
ReplyI refer the hon. Member to the answer given on 20th April to Question UIN 125672.
20 Apr 2026·Department of Health and Social Care·Answered
AskedWith reference to the policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress he has made on defining and applying guidance that permits first in human clinical trial submission for biological therapies where no pharmacologically relevant preclinical animal model exists based only on non-animal data.
ReplyIn line with the Government’s strategy to replace animals in science, the Medicines and Healthcare products Regulatory Agency (MHRA) supports the use of non-animal approaches where they are fit for purpose and accepts that, where a biological product is not pharmacologically active in animals and no relevant animal model exists, studies in animals, including with surrogate molecules, should not be undertaken and first-in-human applications can be supported using non-animal data, such as in vitro methods and computer modelling, to inform expected human exposure and safety. Further information is available at the following link:https://www.gov.uk/government/publications/replacing-animals-in-science-strategy/replacing-animals-in-science-a-strategy-to-support-the-development-validation-and-uptake-of-alternative-methodsMore broadly, alternative methods used to characterise safety must be demonstrated as fit for their intended purpose, and MHRA guidance, published in March 2026, sets out its current approach to medicines using non-animal methods, including how such approaches can support regulatory submissions and the adoption of validated alternatives as they become available. For potency testing and for adventitious agent testing, separate information for manufacturers on controls for batch release is on the MHRA website explaining how adoption of non-animal methods for these purposes is supported. Further information is available at the following two links:https://www.gov.uk/guidance/mhra-approach-to-medicines-using-non-animal-methodshttps://nibsc.org/about_us/our_use_of_animals.aspx
20 Apr 2026·Department of Health and Social Care·Answered
AskedWith reference to the policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress he has made on phasing out preclinical animal testing of biologicals where no pharmacologically relevant animal models exist.
ReplyWhere there is no pharmacologically relevant animal species for testing a biological product, the position of the Medicines and Healthcare products Regulatory Agency (MHRA) is that there should be no studies done on animals, and in March 2026, the MHRA published a statement on its website that included this text: “For certain drug substances that are not pharmacologically active in animals, the MHRA does not support testing in animals (including with surrogate molecules). For this group of drugs, non-animal-based methods suffice to support expectations for efficacy and safety in clinical development”. This position is represented to companies that seek scientific advice from the MHRA on drug development in this context. Further information is available at the following two links:https://www.gov.uk/government/publications/replacing-animals-in-science-strategy/replacing-animals-in-science-a-strategy-to-support-the-development-validation-and-uptake-of-alternative-methodshttps://www.gov.uk/guidance/mhra-approach-to-medicines-using-non-animal-methods
20 Apr 2026·Department of Health and Social Care·Answered
AskedWith reference to the Policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress has he made in replacing the use of animals in botulinum toxin batch potency testing.
ReplyIn line with the Government’s strategy to replace animals in science, the Medicines and Healthcare products Regulatory Agency (MHRA) supports the use of non-animal approaches where they are fit for purpose and accepts that, where a biological product is not pharmacologically active in animals and no relevant animal model exists, studies in animals, including with surrogate molecules, should not be undertaken and first-in-human applications can be supported using non-animal data, such as in vitro methods and computer modelling, to inform expected human exposure and safety. Further information is available at the following link:https://www.gov.uk/government/publications/replacing-animals-in-science-strategy/replacing-animals-in-science-a-strategy-to-support-the-development-validation-and-uptake-of-alternative-methodsMore broadly, alternative methods used to characterise safety must be demonstrated as fit for their intended purpose, and MHRA guidance, published in March 2026, sets out its current approach to medicines using non-animal methods, including how such approaches can support regulatory submissions and the adoption of validated alternatives as they become available. For potency testing and for adventitious agent testing, separate information for manufacturers on controls for batch release is on the MHRA website explaining how adoption of non-animal methods for these purposes is supported. Further information is available at the following two links:https://www.gov.uk/guidance/mhra-approach-to-medicines-using-non-animal-methodshttps://nibsc.org/about_us/our_use_of_animals.aspx
20 Apr 2026·Department for Science, Innovation and Technology·Answered
AskedInnovation and Technology, with reference to the policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress she has made on establishing the Alternative Methods Strategy Delivery Group.
ReplyThe Alternative Methods Strategy Delivery Group first met on 24 February 2026, and its next meeting is scheduled for 28 April 2026.
20 Apr 2026·Home Office·Answered
AskedHow many animals have died during UK preclinical testing for Botox (Botulinum toxin) used in aesthetic applications each year since 2005.
ReplyThe Home Office does not collect data on the fate of animals at the end of procedures. Under the Animals (Scientific Procedures) Act 1986, licensed establishments are responsible for keeping records which include the fate of the animals. Home Office Inspectors in the Animals in Science Regulation Unit may ask to look at these records at any time. The number of animals used in scientific procedures can be found here: www.gov.uk/government/collections/animals-in-science-statistics. This data is broken down by year and by species and type of procedure.To protect human safety there are legal requirements to test the safety and potency of medicinal products and drug substances containing botulinum toxin. The testing of this medicinal product is required by the Medicines and Healthcare Products Regulatory Authority (MHRA).In November 2025, the Government published Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, which includes an aim to apply only validated alternative methods in the pharmacopoeial potency testing of botulinum toxin by the end of 2027.
20 Apr 2026·Department for Science, Innovation and Technology·Answered
AskedInnovation and Technology, with reference to the policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress she has made on restarting the survey on public attitudes to animal research.
ReplyA competition has been launched to secure support in delivering the next waves of the survey on public attitudes to animal research. Feedback from key stakeholders has been sought on the survey questions from the last wave.
20 Apr 2026·Department for Science, Innovation and Technology·Answered
AskedWith reference to the policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress he has made in replacing adventitious agent testing in animals.
ReplyI refer the Hon. Member to the answer I gave on 28 April 2026 to Question 128366.
20 Apr 2026·Department for Science, Innovation and Technology·Answered
AskedInnovation and Technology, with reference to the policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress she has made on working with regulatory agencies to accelerate the replacement of the Rabbit Pyrogen Test with the Monocyte Activation Test across UK guidelines.
ReplyRabbit pyrogen tests were removed from the British Pharmacopeia in 2025 under this Government, meaning that no rabbit pyrogenicity testing should now be conducted in the UK for any pharmacopoeial pyrogen testing purposes. International (ISO) standards for medical devices may require the use of rabbit pyrogen testing for market authorisation for non-UK markets. Where this is the case Prospective Authorisation would need to be granted by the Home Office, no such tests were carried out in 2025. We are working with the Home Office to ensure that no new licences are approved that include the use of the rabbit pyrogen tests where validated alternatives are available.
20 Apr 2026·Home Office·Answered
AskedWith reference to her Department's policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress she has made in strengthening UK guidance on adventitious agents testing.
ReplyThe Government is committed to strengthening guidance on adventitious agents testing in due course, as set out in the strategy.The use of animals in science in the UK continues to be regulated under the Animals (Scientific Procedures) Act 1986, which requires that animals are only used where there is no suitable validated non‑animal alternative, the minimum number of animals is used, and the most refined methods are used to minimise harm.The Government will publish a delivery update, alongside key performance indicators on progress across all elements of the strategy, later in 2026.
20 Apr 2026·Department of Health and Social Care·Answered
AskedWith reference to the Department for Science, Innovation and Technology's policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress his Department has made in applying only validated alternative methods for pharmacopoeial adventitious agent testing for human medicinal products licensed in the UK.
ReplyIn line with the Government’s strategy to replace animals in science, the Medicines and Healthcare products Regulatory Agency (MHRA) supports the use of non-animal approaches where they are fit for purpose and accepts that, where a biological product is not pharmacologically active in animals and no relevant animal model exists, studies in animals, including with surrogate molecules, should not be undertaken and first-in-human applications can be supported using non-animal data, such as in vitro methods and computer modelling, to inform expected human exposure and safety. Further information is available at the following link:https://www.gov.uk/government/publications/replacing-animals-in-science-strategy/replacing-animals-in-science-a-strategy-to-support-the-development-validation-and-uptake-of-alternative-methodsMore broadly, alternative methods used to characterise safety must be demonstrated as fit for their intended purpose, and MHRA guidance, published in March 2026, sets out its current approach to medicines using non-animal methods, including how such approaches can support regulatory submissions and the adoption of validated alternatives as they become available. For potency testing and for adventitious agent testing, separate information for manufacturers on controls for batch release is on the MHRA website explaining how adoption of non-animal methods for these purposes is supported. Further information is available at the following two links:https://www.gov.uk/guidance/mhra-approach-to-medicines-using-non-animal-methodshttps://nibsc.org/about_us/our_use_of_animals.aspx
20 Apr 2026·Department for Science, Innovation and Technology·Answered
AskedInnovation and Technology, with reference to the policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress she has made on applying only validated alternative methods for pharmacopoeial pyrogen testing.
ReplyRabbit pyrogen tests were removed from the British Pharmacopeia in 2025 under this Government, meaning that no rabbit pyrogenicity testing should now be conducted in the UK for any pharmacopoeial pyrogen testing purposes. International (ISO) standards for medical devices may require the use of rabbit pyrogen testing for market authorisation for non-UK markets. Where this is the case Prospective Authorisation would need to be granted by the Home Office, no such tests were carried out in 2025. We are working with the Home Office to ensure that no new licences are approved that include the use of the rabbit pyrogen tests where validated alternatives are available.
20 Apr 2026·Department of Health and Social Care·Answered
AskedWith reference to the policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress he has made on applying only validated alternative methods in the pharmacopoeial potency testing of botulinum toxin.
ReplyIn line with the Government’s strategy to replace animals in science, the Medicines and Healthcare products Regulatory Agency (MHRA) supports the use of non-animal approaches where they are fit for purpose and accepts that, where a biological product is not pharmacologically active in animals and no relevant animal model exists, studies in animals, including with surrogate molecules, should not be undertaken and first-in-human applications can be supported using non-animal data, such as in vitro methods and computer modelling, to inform expected human exposure and safety. Further information is available at the following link:https://www.gov.uk/government/publications/replacing-animals-in-science-strategy/replacing-animals-in-science-a-strategy-to-support-the-development-validation-and-uptake-of-alternative-methodsMore broadly, alternative methods used to characterise safety must be demonstrated as fit for their intended purpose, and MHRA guidance, published in March 2026, sets out its current approach to medicines using non-animal methods, including how such approaches can support regulatory submissions and the adoption of validated alternatives as they become available. For potency testing and for adventitious agent testing, separate information for manufacturers on controls for batch release is on the MHRA website explaining how adoption of non-animal methods for these purposes is supported. Further information is available at the following two links:https://www.gov.uk/guidance/mhra-approach-to-medicines-using-non-animal-methodshttps://nibsc.org/about_us/our_use_of_animals.aspx
20 Apr 2026·Department for Science, Innovation and Technology·Answered
AskedInnovation and Technology, with reference to the policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress she has made on replacing the rabbit pyrogen test.
ReplyRabbit pyrogen tests were removed from the British Pharmacopeia in 2025 under this Government, meaning that no rabbit pyrogenicity testing should now be conducted in the UK for any pharmacopoeial pyrogen testing purposes. International (ISO) standards for medical devices may require the use of rabbit pyrogen testing for market authorisation for non-UK markets. Where this is the case Prospective Authorisation would need to be granted by the Home Office, no such tests were carried out in 2025. We are working with the Home Office to ensure that no new licences are approved that include the use of the rabbit pyrogen tests where validated alternatives are available.
20 Apr 2026·Department for Science, Innovation and Technology·Answered
AskedInnovation and Technology, with reference to her Department's policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress her Department has made in (a) developing AI prediction tools and (b) obtaining kinetic data from combining tests with general toxicity testing.
ReplyThis is an area of extensive effort across industry and stakeholders. NC3Rs are funding development of a virtual dog to replace dogs in second species testing (Virtual Second Species Innovation Platform). We continue working with partners to develop resources to expand these efforts.The strategy has not committed to obtaining kinetic data. Basket 2 sets out long‑term ambitions that must be science‑led, partnership‑based and delivered over time.The strategy aims to use validated alternative methods to reduce use of dogs and non‑human primates in dedicated Pharmacokinetic studies for human medicines by at least 35% by 2030.
20 Apr 2026·Home Office·Answered
AskedFor what application are the 3 current active licences which authorise the use of the Forced Swim Test in preclinical animal testing.
ReplyThe Home Office publishes annual National Statistics on the use of animals in scientific procedures in Great Britain under the Animals (Scientific Procedures) Act 1986.As part of these statistics, information is collected and published on techniques of special interest. In 2024, the statistics included the forced swim test as a technique of special interest for the first time and includes information on the purpose of the research. All procedures were performed for the purpose of basic research in the areas of the nervous, endocrine and sensory systems, and were either mild or moderate severity.The annual statistics for 2025 will be published this year. The published annual statistics are available at:https://www.gov.uk/government/collections/animals-in-science-statistics
20 Apr 2026·Department for Science, Innovation and Technology·Answered
AskedInnovation and Technology, with reference to her Department's policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress she has made in obtaining the full validation of the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative to predict the proarrhythmic potential of new drugs.
ReplyThe strategy has not committed to obtaining the full validation of the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative to predict the proarrhythmic potential of new drugs.Basket 2 of the strategy outlines long‑term ambitions which must be science‑led, partnership‑based, and delivered over time.The strategy aims to use validated alternative methods to reduce the use of dogs and non-human primates in dedicated Pharmacokinetic studies for human medicines by at least 35% by 2030.
20 Apr 2026·Ministry of Defence·Answered
AskedPursuant to the answer of 16 April 2026 to question 121654 on Navy: Dockyards, has the contract now been signed to extend the Future Maritime Support Programme (FMSP) to cover the period from April 2026 up to October 2028.
ReplyProgress continues to be made on the extension of the Future Maritime Support Programme. Contracts covering the majority of ship‑related services have been agreed, with the remaining elements in the process of finalisation, while arrangements are in place to ensure continuity of submarine support services ahead of a new contractual agreement expected to commence later in 2026.
20 Apr 2026·Department for Science, Innovation and Technology·Answered
AskedInnovation and Technology, with reference to her Department's policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress she has made in reducing animal use in cardiovascular safety studies.
ReplyBasket 2 of the strategy outlines long‑term ambitions which must be science‑led, partnership‑based, and delivered over time.Innovate UK in partnership with NC3Rs launched a funding call supporting the development and commercialisation of alternative methods for assessing the preclinical cardiovascular safety of new medicines: Contracts for Innovation: industrial human relevant drug models – UKRI. This follows work led by IUK and NC3Rs to build a community around this opportunity. https://www.ukri.org/opportunity/contracts-for-innovation-industrial-human-relevant-drug-models/The strategy aims to use validated alternative methods to reduce the use of non‑human primates and dogs in dedicated cardiovascular safety studies by at least 50% by 2030.
16 Apr 2026·Department for Science, Innovation and Technology·Answered
AskedInnovation and Technology, with reference to the Policy paper: “Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods”, published on 11 November 2025, what progress has she made in increasing challenge-led innovation funding schemes to deliver alternative methods priorities for a) development and b) validation.
ReplyThe commitments to increase investment and expand challenge led innovation for alternative methods are being led by UKRI.The Strategy was supported by £75m of funding and commits to increasing investment in alternative methods. UKRI has been in discussion to consider the most effective delivery approach and £20 million of increased funding is already available through the Pre‑clinical Translational Models Hub funding call, launched in March 2026. In addition, Innovate UK launched a £2 million Contracts for Innovation competition in February 2026.