2016Nu37500 Requests for cancellation, such as the receipt and disposition of government contributions;

1. A university, industry-academic cooperation foundation;

2. B

Minister of Oceans and Fisheries

Seoul Administrative Court Decision 2014Guhap75049 decided February 4, 2016

November 8, 2016

December 6, 2016

1. All appeals filed by the plaintiffs are dismissed. 2. The costs of appeal are assessed against the plaintiffs.

The judgment of the first instance is revoked. On September 24, 2014, the Defendant’s recovery of 70% (1,462,300,000 won) of the government contributions in the last year against the Plaintiff A University Industry-Academic Cooperation Foundation and the two-year disposition of restriction on participation against the Plaintiff B is revoked.

1. Basic facts

A. The Plaintiff A.I. Industry Cooperation Foundation (hereinafter referred to as the “Plaintiff Cooperation Agency”) was authorized to carry out the “C Research and Development Project” among the “C Research and Development Project” ordered by the Defendant in 2004, and the Plaintiff B is the head of the research group who carried out the instant project as a professor of the International Institute of Science and Technology (hereinafter referred to as the “Korea Institute of Science and Technology”). The Defendant had the Korea Institute of Marine Science and Technology Promotion (hereinafter referred to as the “Institute”) vicariously carry out the task planning, evaluation, etc. of the instant project.

B. The instant project aims at developing at least eight original candidates and new technologies for the development of a treatment system for three representative diseases of the present people (e.g., Ambassador disease, immunodeficiency disease, infectious disease), and at least eight new technology transfer by 2013. The objectives at each stage are as follows.

(1) Stage 1 (2004~2006) Development of effective marine substances reagents, securing of marine biological resources in patent applications, establishment of human body and hospital germs-based genetic information and mass search method for marine natural substances based on disease outbreak and prevention, development of effective marine organisms cultivating and cultivating technology through determination of the refining and structure of marine natural substances, and synthesis of active marine natural substances in bulk.

(2) Development of fresh substances leading to new drugs at two levels (2007~2009), 207-209

- Establishment of natural substances and synthetic derivedide compounds based on disease-related single-clateral structure;

- evaluation of pharmacological vitality of leading substances using disease oil and electronic information;

- the optimumization of leading material on the basis of before the disease;

·Development of mass technology for leading materials for pre-clinical trials

(3) Massthesis of useful natural substances to secure large quantities of useful natural substances through the development of global new drugs (2010~2013) and technology transfer marine life.

- Development of new drugs candidates through clinical trials (toxicity and stability) before leading substances;

-technology transfer for industrialization

C. The instant project was carried out without a big problem for the first phase (development of effective materials) and second phase (development of leading materials), but it was classified as the subject of in-depth evaluation on the grounds of the results of the interim evaluation conducted by the Promotion Agency for the second year (2011), such as the 3rd phase (201), 'the uncertainty of the structure of the research team', 'data omission in preparation of research results', 'the completion of mass production of candidate materials for the transition status', 'the failure to reflect opinions on the evaluation for the second year', and 'in-depth evaluation on January 19, 2012. The results of the in-depth evaluation showed a lower point of 60.7 points (100 points) as a result of the in-depth evaluation, and the following matters were presented as a comprehensive opinion.

- modify the research objectives to the level that they can achieve, and reduce research costs;

- As a result of the present study, eight technology transfer, which is the initial goal, seems impossible to reach the original eight technology transfer. Accordingly, the research system is interrupted and the research is discontinued at the present stage of re-establishment of the objectives that can be innovative and reached, and the research planning and research personnel are completely reconcepted by concentrating on prospective candidates (e.g., CMF3571(urine), CMF4813(inter-regional), etc. on the basis of the research personnel’s selection, and only the research expenses required for the technology transfer of these materials are subsidized by reducing the budget.

- the network to present specific data on how to secure a large volume of candidate substances and their economic feasibility;

D. Accordingly, the Agency set down the basic research-oriented strategy that has been progress so far with the Plaintiff Cooperation Agency as “not less than two technology transfer goals,” and tried to make choice and concentration to derive visible outcomes in consideration of economic feasibility, etc., regardless of the last three stages, and urged the Plaintiff Cooperation Agency to reorganize its structure. However, the Plaintiff Cooperation Agency’s achievements in research and development in 2012 were also 60.71 p.m.

E. On April 5, 2013, the Agency entered into a research and development agreement with the Plaintiff Cooperation Agency with the amount of KRW 2,089,000 for research and development expenses (in the relevant year) for the last year of the instant project (from January 1, 2013 to December 31, 2013). The final goal was to develop three types of creative new medicine candidates for the development of communicable diseases, immunity and sediative diseases, and infectious disease treatment chemicals, and conduct two technology transfer by 2013.

F. During the instant project period (from October 1, 2004 to December 31, 2013), government contributions were used in total of KRW 32,683,546,000 as stated in the annual agreement amount as shown in the instant project. Since the completion of the instant project on December 31, 2013, the Promotion Institute organized an evaluation committee with experts in the relevant field as its members for the final evaluation of the instant project. On March 7, 2014, the Evaluation Committee rendered a determination on the Plaintiff’s research and development outcomes with the final evaluation point of KRW 57.67 on the following grounds (Article 39(1) of the Regulations on the Operation of Research and Development Projects provides that the head of a specialized institution may suspend research and development tasks corresponding to less than 60 points as a result of the interim evaluation and phase evaluation, Article 36 of the Guidelines for the Management of Research and Development Projects provides that the final evaluation of research and development tasks and the final evaluation point of less than 60 points may be achieved (the final evaluation point).

- fail to produce the performance of candidates and at least two new technology for the development of 3rd diseases (e.g., Ambassador, immunity, sediment, infectious diseases);

The results of the technical transfer presented by the Plaintiff Cooperation Agency are not the transfer of innovative new chemical substances originally planned as a mass production technology of marine hemossis, but it is difficult to regard the test products produced through venture businesses as a new chemical candidate for marine natural substances (functional food).

- Although the technology development of leading materials, which is an important basis for achieving the final goal, is not properly conducted, as well as the toxic test for the development of candidate materials, is also presented, the effect of which should be proved in a laboratory model corresponding to this compound adaptation certificate in order to demonstrate validity as a basic submission data for IND that is not different from that for the manufacture of the materials. However, in the case of CMFD6971, among the three types of candidate materials presented by the Plaintiff Cooperation Agency, the basic toxicity test is conducted without proof of the effect of medicine in laboratory animals, and it is doubtful that the basic toxicity test is conducted without proof of the effect of medicine in laboratory animals.

- The construction of Rabler(DB) is insufficient because information management and real management on marine extractions that can be presented as an important outcome of the project in this case are not properly managed.

H. On April 7, 2014, the Plaintiff Cooperation Agency filed an objection against the research objectives of the instant project with the purport that “INDGLP test (former Clinical Test conducted in accordance with the strict requirements prescribed by relevant Acts and subordinate statutes, such as Pharmaceutical Affairs Act, to obtain prior data on permission for clinical trials)” was not included, but unfair evaluation was conducted by evaluating the development of candidate materials through GLP test as the evaluation criteria of the Plaintiff Cooperation Agency, and the Plaintiff Cooperation Agency has developed three kinds of creative new technology and achieved the final goal of the instant project by transferring two new technology.” However, the Committee members of the Promotion Agency, composed of outside experts in the relevant field, raised an objection against the instant evaluation results on the following grounds: (a) the Plaintiff’s 2nd evaluation criteria for the instant project based on the 3nd evaluation standards, which were presented by the members of the Promotion Agency; (b) the Plaintiff’s final evaluation criteria for the 1st evaluation of candidate materials that failed to meet the objectives of the instant project; and (c) the 2nd evaluation criteria for the Plaintiff’s final evaluation standards for the 2nd.

I. After that, on May 28, 2014, the Promotion Agency examined the actual condition of the Plaintiff Cooperation Agency's implementation of the project, as a result of the follow-up measures according to the above failure judgment, and judged that "the development of technology, the securing of patents, theses, etc., were relatively well-grounded and faithfully performed." However, in the research contents, the Promotion Agency judged "the implementation of the project in good faith" as "the implementation of the project in good faith." However, in the detailed review opinion of each inspection item, there was no thesis on the efficacy in relation to the three kinds of candidates, and it did not have been developed for the purpose of food or health functional food without being developed for the new drug candidate material as provided for in the initial research objective, and there were many problems such as "the management of marine living resources, etc. through the project in this case is insufficient and there was no outcome of technology transfer negotiations."

(j) In order to deliberate on matters concerning restrictions on participation and recovery of project costs under Article 11-2(1) of the Framework Act on Science and Technology, the Agency organized a sanctions evaluation group pursuant to Article 27(5) of the Regulations on the Management, etc. of National Research and Development Projects (amended by Presidential Decree No. 26729, Dec. 22, 2015; hereinafter the same shall apply). The sanctions evaluation group decided as "faithful performance" on June 27, 2014. However, in light of the detailed review opinions, most of the problems were pointed out, and it is anticipated that it will be difficult to utilize them in the future. ② The evaluation point of the performance of the research task is less than 44 points out of 70 points (in case of a bona fide performance reference point, 41 points).

(k) Accordingly, on September 24, 2014, pursuant to Article 11-2 of the National Science and Technology Act and Article 27 of the Regulations on the Management, etc. of National Research and Development Projects, the Defendant issued a disposition to recover 70% (1,462,30,000) of the government contributions in the last year to the Plaintiff Cooperation Agency, which is the main research institute for the instant project, on the grounds of “satisf as a result of the final evaluation”, and issued a disposition of restriction on participation against Plaintiff B, who is the main research institute for the instant project (hereinafter referred to as “instant disposition”).

[Reasons for Recognition] Facts without dispute; Gap evidence 1 through 3, 7 through 17, 25, Eul evidence 1 through 5, 10, 11 (including each number, if any; hereinafter the same shall apply); fact-finding with respect to the Agency of the first instance court; the purport of the whole pleadings;

2. Whether the instant disposition is lawful

A. The plaintiffs' assertion

(1) Although the Plaintiff Cooperation Agency has developed three kinds of creative new technology, transferred two new technology to achieve the final objective of the instant project, the Promotion Agency’s evaluation committee deems that the Plaintiff Cooperation Agency was unable to achieve the final objective of the instant project on the ground that it did not conduct the GLP test, and determined that the Plaintiff Cooperation Agency was not able to achieve the final objective of the instant project on the ground that it did not conduct the GLP test, which was based on an important evaluation criteria, and determined the outcome of the Plaintiff Cooperation Agency’s research and development outcomes as a failure, which is based on an erroneous evaluation criteria, and thus, the instant disposition is unlawful as it reflects the results of deliberation by the sanctions evaluation committee based on the evaluation results of the erroneous evaluation committee, and thus should be revoked.

(2) Even if the project of this case is deemed to be a project that has failed to meet the evaluation criteria of the Promotion Committee, the project of this case was judged to be a "faithful performance" as a result of the Promotion Committee's on-site performance of the Plaintiff Cooperation Agency, and since the final evaluation score of the research and development outcomes of the Plaintiff Cooperation Agency is 57.67 points for 57.67 points, the project of this case is not a "faithful failure" and the result of research and development stipulated in Article 11-2 (1) 1 of the Science and Technology Act is not a case.

(3) Even if the result of the final evaluation of the instant project is subject to sanctions under Article 11-2(1) of the Science and Technology Act, the Plaintiff Cooperation Agency received 60 or more points for each year’s successful task except the final evaluation, and obtained 57.67 points for less than 60 points each time in the final evaluation, and the said evaluation point was less than 2.33 points for less than 2.33 points at the above standard point, and there was no fact that Plaintiff B embezzled or unconscientious conducted research in good faith. The Plaintiff Cooperation Agency executed most of the budget with the research funds. The Plaintiff Cooperation Agency executed most of the budget as the research funds. The operation of the project is finished, such as the suspension of the payment to its employees due to the above recovery disposition against the Plaintiff Cooperation Agency, and most of the studies conducted by Plaintiff B are conducted through the State-Support Research and Development Project. In light of the fact that the participation restriction on Plaintiff B’s participation in research and development project for 2 years above is limited for a considerable period of time, it constitutes an abuse of discretionary power against the Plaintiffs.

(b) Whether there was an error in the evaluation criteria of the Promotion Committee

(1) Facts of recognition

(A) The instant project is a research and development project that finds new drugs candidates effective in treating specific diseases, covering all marine natural substances. The general development process based on the instant project is as follows.

A person shall be appointed.

(B) According to the C’s studies based on the initial project of this case, the project was planned in the order of the development of effective materials (2004 to 2006), the development of leading materials (2007 to 2009), the development of the three-stage (2010 to 2013), the four-stage clinical trials (2014 to 2016), the five-stage clinical trials (2016), the six-stage clinical trials, and the provisional application for new drug sales licenses. The project of this case was planned in the three-stage research and development, namely, the development of new drugs, the development of new drugs, the development of leading materials that prove efficacy from the model of the disease animal, and after the development of leading materials that prove efficacy, the project of this case was planned in the three-stage research and development stage of the comprehensive concept rug-based test target materials (the research and development process) for the leading materials developed.

(C) However, on March 18, 2011, when entering into a research and development agreement with the Promotion Agency in 2011, the Plaintiff Cooperation Agency expressed a plan to attempt to conduct the GLP test for one candidate from February 2, 2012 to November 22, 2011 on the basis of the plan. Based on the plan, the Plaintiff Cooperation Agency conducts the GLP test from April 4, 2012 to 120 billion won on the premise that the research funds were subsidized for KRW 12 billion, and submitted a research plan to the Promotion Agency in 2013 on the premise that the research funds were subsidized for KRW 12 billion. However, the Plaintiff Cooperation Agency submitted a research plan to delete part of the GLP test from March 21, 2012 to 2012 and submitted a revised plan to replace it with the drug evaluation plan to 201. The Plaintiff and the Plaintiff were finally excluded from the research and development funds under the GLP test plan for the year 2010.

(D) After November 30, 2012, the Plaintiff Cooperation Agency submitted a research plan to the Agency that “to conduct the GLP test” in the quarter of April 2013 on the premise of subsidization of research support funds of KRW 62.6 billion on November 30, 2012, but upon request of the Agency to revise and supplement that application research funds are excessive.

On January 18, 2013, the research support fund applied for was reduced to KRW 25.4 billion, and the revised research plan was submitted along with "the promotion plan excluded from the schedule of the GLP test". In the end, on April 5, 2013, the Plaintiff and the Promotion Institute submitted the revised research plan with research and development expenses of KRW 2,089,00,000, which was executed between the Plaintiff and the Promotion Institute as of KRW 2,089,00,000, there is no schedule for the annual (stage) performance plan attached to the research and development agreement in 2013.

(E) In order to conduct the GLP test on a new drug candidate, the cost of requesting testing for the CRO, which is a non-clinical trial specialized institution, and the cost of producing candidate material for CMO, which is a candidate material production agency. The cost of GLP test on a candidate for a new drug requires approximately KRW 12-1.7 billion.

[Ground of recognition] The descriptions of Gap evidence Nos. 5, 23 through 25, 27 through 53, 55 through 59, 64, witness D's testimony and the purport of the whole pleadings

(2) Determination

(A) The following circumstances, i.e., the evidence and the purport of the entire pleadings, which are acknowledged as follows: ① The GLP test generally does not cover leading materials; ② the process of verifying toxicity, stability, etc. among leading materials verified in the disease animal model; ② the purpose of the instant project is to develop new drug substances before entering the GLP test for the 20th anniversary of the date of the public announcement of the instant project (2010~2013), but it appears that the new drug development through the GLP test for the 20th anniversary of the date of the public announcement of the instant project (20th 2010-2013) is not relevant to research and development; ② the new drug development through the GLP test for the 1st 2nd 3rd 2nd 2nd 2nd 3rd 2nd 3rd 20th 2nd 3rd 2nd 3rd 20th 2nd 201st 3rd 201st 3rd 20.

(B) Furthermore, we examine whether the Plaintiff Cooperation Agency lowers the evaluation score on the research and development outcomes of the Plaintiff Cooperation Agency by misunderstanding that the members of the Promotion Committee are included in the research objectives of the instant project and determining that the Plaintiff Cooperation Agency did not develop candidates and transfer technology through full-time materials in accordance with the GLP test criteria.

1) The following circumstances revealed through the above evidence and the overall purport of oral argument, i.e., ① the KIM has presented the first instance court's fact-finding on the fact-finding of the first instance court's final objective of the project in this case; ② the KIM replys that "the achievement level of research objectives", "quality of the research implementation process" and "quality of the research and development outcomes" should be reflected in the evaluation of research and development outcomes; ② the main reasons why some members of the KIM have judged the plaintiff's research and development outcomes as "unsatisfy" are "unsatisfy materials", "unsatfy trial for the development of candidate materials", "it is not proper that the previous clinical trial for the development of candidate materials", "in order to prove the validity as basic materials for the research and development, it should be proved that the effect should be proved from the laboratory model corresponding to the certificate of adaptation to this compound," and ③ the plaintiff's research and development results should be included in the GPE evaluation committee's evaluation target.

2) However, recognition is based on the evidence and the purport of the entire pleadings as seen above.

The following circumstances, i.e., the results of the Promotion Committee: (i) although the Plaintiff Cooperation Agency presented three kinds of candidate materials, it is difficult to conclude that the materials manufacturing process has water quality to the extent possible to enter the clinical trial (GLP test); (ii) in the case of CMFD6971, among three kinds of candidate materials presented by the Plaintiff Cooperation Agency, it is difficult to conclude that the Plaintiff had an objection to the results of the GLP test as the criteria for evaluation of whether the Plaintiff was carrying out the GLP test which was not included in the research objectives of the instant project, and it is difficult to conclude that the Plaintiff had an objection to the results of the above GPE test on the premise that there were no errors in the examination and development guidelines of the relevant field, including (iii) the Plaintiff’s initial research and development guidelines which were presented before the date of the examination and development of the PEP test, and (iv) there were no errors in the examination and development guidelines that were presented before the date of the examination and development guidelines in the instant case.

3) In addition, the Evaluation Committee decided the project of this case at 57.67 points in the final evaluation score by taking into account the following: (a) not only the "in evaluation of the research and development outcomes of the Plaintiff Cooperation Agency" but also the "in addition, the actual failure to achieve the final objective of the project of this case" as the result of the failure to present the results of the development of new drugs candidates and technology transfer; (b) failure to secure large volume of leading material, which is an important basis for the final objective of the project of this case; and (c) failure to build separate component structure Rabur(DB). Therefore, it is difficult to conclude that the fact-finding results of the court of first instance conducted the previous examination by the court of first instance on the fact that the Plaintiff Cooperation Agency did not perform the previous examination was a critical cause for the determination of the "Evaluation Committee", and there is no other evidence to recognize this otherwise.

(C) Therefore, this part of the plaintiffs' assertion is without merit that the evaluation criteria for the implementation of the GLP test, which was not included in the research goal of the project in this case, were determined lower than the evaluation score on the ground that the results of the evaluation of the results of the research and development conducted by the Plaintiff Cooperation Agency were not conducted by the Plaintiff Cooperation Agency. Whether the final objective of the project in this case is achieved or not.

In full view of the above facts, including the above facts, the final objective of the project in this case was to develop the 'three-class creative new drug candidates' and to industrialize them. However, the Plaintiff Cooperation Agency failed to reach the selection stage of new drug candidates as the research objective at the project in this case, and it did not transfer one new drug candidate to the pharmaceutical company, etc. by December 31, 2013, and thus, it cannot be deemed that the Plaintiff has achieved the final objective of the project in this case (the 'marine convenience production technology' claimed as the project performance in this case cannot be deemed as having transferred the new drug candidates as originally planned for the project in this case, and it cannot be deemed that the new chemical substance was transferred to the pharmaceutical company, etc., which was not the new chemical substance that was originally planned for the project in this case after the period of the project in this case, but it cannot be deemed that the new chemical substance in the marine technology transfer did not reach the level of functionality of food, but it cannot be deemed that the Plaintiffs submitted the new chemical substance in this case to the above 2130th new chemical.

Therefore, this part of the plaintiffs' assertion that there is no reason for disposition by accomplishing the final goal of the business of this case is without merit.

(d) Whether research and development outcomes are extremely poor and determined as a failed research and development task;

(1) Article 11-2 (1) 1 of the Framework Act on Science and Technology provides that "the head of a central administrative agency may restrict the participation of a national research and development project under his/her jurisdiction within five years, where research and development outcomes are extremely poor and the central administrative agency has been suspended or determined as a failed research and development task due to the evaluation conducted by the relevant central administrative agency, and may recover all or part of the project funds already contributed or subsidized, but may reduce or exempt the period of restriction on participation and the amount of recovery of project funds where research and development is deemed to have been performed faithfully."

In light of the structure, contents, etc. of the above sanctions, where research and development results are determined as a failed research and development task according to the evaluation conducted by the central administrative agency due to extremely poor research and development outcomes, restrictions on participation and recovery of contributions under the above provisions may be imposed even if it is deemed that the research and development is faithfully performed, and the faithful performance of research and development is merely a cause

Meanwhile, since the determination on whether research and development projects conducted appropriately in accordance with the initial plan requires a high level of professional judgment on science and technology, if the evaluation of research and development outcomes requires a high level of professional judgment, the evaluation is conducted by organizing a committee composed of professional human resources in the evaluation of research and development outcomes, and if the results of research and development were to be determined as a failed research and development task due to extremely poor outcomes through the reexamination procedure following an objection to the evaluation results, the said determination cannot be deemed unlawful unless it is not based on factual basis or considerably unreasonable under the social norms (see, e.g., Supreme Court Decision 91Nu634, Apr. 24

(2) The following circumstances acknowledged based on the above basic facts, the evidence and the purport of the entire pleadings, i.e., the Plaintiff Cooperation Agency, within the project period, failed to achieve the final objective because it failed to transfer technology for the development of new drugs candidates and commercialization as presented in the research objective of the instant project, and failed to secure large-scale leading materials, which are an important basis for the achievement of the final objective, and failed to establish a separate component Rabur (DB) structure. (ii) After the completion of the instant project, the Plaintiff Cooperation Agency was judged as having been judged as having 57.67 points in the final evaluation of the instant project as a result of the Promotion Evaluation Committee composed of experts in the relevant field, and the said evaluation was based on objective facts, such as the lack of the final objective of the project. (iii) The Plaintiff Cooperation Agency cannot be deemed as having any error in the evaluation criteria of the Evaluation Committee on the research and development outcomes of the Plaintiff Cooperation Agency’s final evaluation, and the Defendant’s objection against the research and development task was extremely inappropriate due to its dismissal.

(3) Therefore, this part of the plaintiffs' assertion is without merit.

(e) Whether an excessive sanction constitutes deviation or abuse of discretionary power;

(1) Whether a punitive administrative disposition deviatess from or abused the scope of discretionary authority shall be determined by comparing and comparing the degree of infringement of public interest and disadvantages suffered by an individual due to such disposition, by objectively examining the content of the act of violation and its degree of violation, the necessity of public interest to be achieved by the relevant disposition, the disadvantages to be borne by an individual, and all the relevant circumstances (see, e.g., Supreme Court Decision 2011Du31635, Nov. 15, 2012).

(2) Article 27(1)1 of the Regulations on the Management, etc. of National Research and Development Projects, which are Presidential Decrees, provides that the period of restriction on participation shall be three years in cases where a central administrative agency has been determined as a failed task due to an extremely poor research and development outcomes, and Article 27(11) [Attachment 5] 1 of the Regulations provides that "within the total amount of contributions for the pertinent year" shall be excluded from the evaluation conducted by the central administrative agency due to extremely poor research and development outcomes. The defendant recognized the Cooperation Agency as faithfully performing research and development projects, and thus, reduced the amount of the project funds to 70% of the government contributions for the last 10 years since the date of the execution of the above research and development projects, as well as the amount of funds to be disposed of by the public research and development project.

(3) Therefore, the plaintiffs' assertion on this part is without merit.

3. Conclusion

Therefore, the plaintiffs' claim of this case is dismissed in its entirety as it is without merit, and the judgment of the court of first instance is just in its conclusion, and all appeals by the plaintiffs are dismissed as it is without merit, and it is so decided as per Disposition.

The presiding judge, assistant judge and assistant judge

Judges Min Young-young

Judge Chuncheon

1) The term "unfaithed task" is divided into "unfaithed failure" (if the development of technology is performed faithfully) and "unfaithed failure" (if the project is performed in good faith, such as development of technology, management of project costs, and enforcement).

(ii) identify the side effects, toxicity, effects, etc. of newly developed new drugs using animals before conducting clinical trials for people;

In general, the test is called ‘clinical trial', and the standards for non-clinical trial management are announced by the Ministry of Food and Drug Safety.

H) Performance through CTRO, a specialized institution for non-clinical trials, under strict requirements in accordance with the GLP ("GLP"),

GLP test and (2) Pursuant to the GLP because it aims at the approximate toxicity assessment of new drugs through single or shortly repeated toxicity tests.

There is no necessary mon-GLP test.

A person shall be appointed.