36-1 Shimizu-cho, Itabashi-ku
Tokyo 174-0053, Japan
www.mediford.com

Guidelines for Animal Experiments
Mediford Corporation

1.

PurposeThe Guidelines for Animal Experiment (hereinafter Guideline) is for Mediford
Corporation (hereinafter Mediford) to conduct animal experiments appropriately as
recommended by AAALAC International. Moreover, the Guideline aims to promote
appropriate conduct of animal experiments from the viewpoint of animal protection
and welfare as well as scientific aspects by stipulating basic matters to be observed
based on laws, standards, and guidelines.

2.

Applicable Scope
This Guideline applies to all animal experiments for research, testing, and education
purposes operated at the Kashima and Kumamoto Laboratories (hereinafter institution)of Mediford. This Guideline is also applicable to the case of transportation as well as
handling of animals in outsourced studies conducted at external facilities.

3.

Definition
The terms used in this Guideline shall be defined as follows:
Animal experiment:
Use of animals for testing, research, or manufacture of biologicalproducts and education
Laboratory animal:
Animals housed or kept at the institution for use in animal experiments(including transportation to and between facilities)
Facility:
Facilities to conduct housing or management of laboratory animals oranimal experiments
Director of institution:
Person with overall responsibility in the institution as Institutional
Official (IO) for conduct of animal experiments and management offacilities
Attending Veterinarian (AV):
Person responsible for the health and well-being of all animals used at
the institution, and provides guidance and supervision on veterinary
care to comply with this Guideline.
Veterinarian appointed by AV:
Veterinarians appointed by AV have the same responsibility as AV for
the instructions.
Study Director (SD):Person responsible for all duties related to the study.
SD can act as the principal investigator (PI) when the institution
corresponds to the test site of a multisite study.
Manager :A collective name of managers such as AV designated by IO and GLP
managers (animal care manager, facility maintenance manager)
designated by facility manager
SOP： Standard operating procedures used at the institution
AAALAC International:
Association for Assessment and Accreditation of Laboratory AnimalCare International4.

Responsibilities of Institutional Official (IO)
IO bears the final responsibility for all animal experiments conducted at the institution.
(1)
Formulation of the Guideline and verification of compatibility(2) Establishment of IACUC and appointment of IACUC members and AV(3) Approval of animal experiment protocols and amendments(4) Overall comprehension of the results of animal experiments from experimentcompletion reports(5) Provision of education and training to IACUC members and all personnel involvedin the care and use of animals(6) Implementation of self-inspection and evaluation, and program review by AAALAC
international(7) Information disclosure

5.

Responsibility of Institutional Animal Care and Use Committee (IACUC)
IO establishes IACUC for proper conduct of animal experiments. IACUC consists of(1) AV, (2) those who have excellent insights regarding animal experiments, (3) those
who have excellent insights regarding laboratory animals, (4) those who have otheracademic experience, and (5) those who do not have biological or chemical duties, and(6) representatives of the general public (external committee members) who are not
involved in animal experiments. In addition, IO appoints an IACUC chair and secretariat.
No particular term of office is set. IACUC carries out the following tasks after being
consulted by IO.
(1)Reviewing of animal experiment protocols submitted from SDs based on therelevant guidelines and reporting of the results to IO.
(2) Provision of advice to IO on the results of animal experiments as necessary(3) Holding IACUC meeting for supervision and evaluation of the program(4) Monitoring of active projects (post approval monitoring [PAM]) to confirm that theresearch is being conducted as approved and animal well-being is notcompromised.
(5) Self-inspection/evaluation and verification concerning compatibility to the(6)Guideline and reporting to IO
Confirmation of appropriateness of the Guideline and reporting to IO

6.

Responsibility of Attending Veterinarian (AV)AV is responsible for the health and well-being of all animals used at the institution,and shall provide guidance and supervision of all elements associated with animal careand use (animal maintenance and housing). In addition, AV shall guarantee that theprogram of the institution is in accordance with the Guide for the Care and Use ofLaboratory Animals.

7.

Planning experiments
Animal experiments must be designed and carried out in accordance with 3Rs, which
are the international principles of animal experiments based on scientific rationale andstipulated in laws, standards, and guidelines.
Replacement ： Replace the use of animals to the extent possible to achieve thepurpose of the research
Reduction： Reduce the use of animals to the extent possible to achieve thepurpose of the research
Refinement： Refine the use of animals by selecting methods that would notcause pain to the animals to the extent possible to achieve thepurpose of the research
The 3Rs principles are not only the ideology of animal experiments but also theideology of handling laboratory animals. Therefore, animal experiments should beappropriately planned by SDs in consideration of the 3Rs principles to the extent
possible to achieve the purpose of the research.

8.

Responsibility of Study Director (SD)SDs have the following responsibilities in implementation of studies.
(1) Preparation of experiment design, submission of animal experiment protocol, andacquisition of approval from IO(2) Administration and oversight of approved protocol in practice(3) Reporting to AV when there is any concern in animal health condition(4) Reporting of study results to IO at completion of study

9.

Application for animal experiment(1) Animal experiment protocol
When conducting an animal experiment, SD shall prepare an experiment protocol
and submit it through the animal experiment application system. The animalexperiment protocol submitted is reviewed by IACUC in the animal experimentapplication system, and the result is reported to IO. IO notifies the results of review
to the SD.

(2) Amendment to animal experiment protocol
When there is an amendment to the animal experiment protocol, SD shallprepare an animal experiment protocol amendment and submit it through theanimal experiment application system.
The animal experiment protocol
amendment submitted is reviewed by IACUC in the animal experiment application
system, and the result is reported to IO. IO notifies the results of review to the SD.
(3) Reporting of results at completion of animal experiment
At completion of the approved animal experiment, SD shall promptly report thestudy results to IO through the animal experiment application system. IO notifies
the results of review to the SD.

10. Experiment operations
In conducting animal experiments, the pain caused to laboratory animals should be
reduced to the extent possible in scientific use and be controlled in conformity to therelevant laws and standards. SDs shall determine the contents of experiments inconsideration of the elements listed below.
(1) Physical retention(2) Feeding and water supply restriction(3) Surgical procedures(4) Pain treatment, anesthesia, and postoperative management(5) Humanitarian endpoint(6) Euthanasia(7) Safety management
11. Housing and management of laboratory animals
In consideration of animal welfare, in order to ensure the safety of personnel while
increasing the scientific reliability of animal experiment data, SDs, AV, animal caremanager, quarantine manager, and facility maintenance manager shall cooperate toproperly house and maintain laboratory animals under the guidance of IO.
12. Animal housing environment
All personnel involved in care and use of animals must follow the standards specified
in SOP for the items listed below in order to provide appropriate housing conditions forlaboratory animals.
(1) Social housing and enrichment(2) Housing space(3) Environmental temperature and humidity(4) Ventilation(5) Lighting(6) Feed and drinking water(7) Bedding and flooring(1) Noise and vibration

13. Healthcare of laboratory animals
Personnel involved in care and use of animals shall provide necessary healthcare toprevent laboratory animals from being injured or getting sick due to any cause
unrelated to the purpose of animal experiments. When laboratory animals are injured
or get sick, appropriate treatment or prompt measures shall be provided to the extent
it does not interfere with the achievement of the purpose of animal experiments.
14. Facilities
IO shall construct and operate facilities under the guidance of the person in chargeof facility maintenance, while paying special attention to the requirements for research
execution, animal physiology, ecology, habits, and requirements for hygiene
management.
15. Safety management
Under the direction of IO, the person in charge of safety management shall endeavor
to ensure the safety and health of personnel at the institution based on relevant lawsand regulations.
16. Implementation of education and training
IO shall provide necessary education and training to all personnel involved in careand use of animals. Education and training must be carried out before engaging inanimal experiments, and it is desirable to be continued as necessary thereafter.
From the viewpoint of conducting proper animal experiments, the following items shallbe included as items for education and training.
(1) Matters concerning related laws, ordinances, guidelines, and regulations(2) Matters concerning animal experiments and handling of laboratory animals(3) Matters concerning care and management of laboratory animals(4) Matters related to ensuring safety
17. Self-inspection/Evaluation and verification regarding compatibility to the Guideline
In order to ensure transparency regarding the implementation of animal experiments,
IACUC shall perform self-inspection and evaluation regarding compatibility to theGuideline every 6 months at the institution and report to IO.
18. Information disclosure
IO shall publish information on animal experiments (e.g., self-inspection results,
verification results by AAALAC International, etc.) about once every year on the websiteof Mediford.

19. Memorial service
In principle, IO shall hold an animal memorial service once every year with theattendance of personnel involved in animal experiments in order to deepen the interestand understanding of protection and proper care of animals, and to memorialize theanimals that have contributed to the prosperity and welfare of humankind.
Latest update November 01, 2023