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5 The Korean Center for the Validation of Alternative Methods (KoCVAM)

5 The Korean Center for the Validation of Alternative Methods (KoCVAM)

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14



International Harmonization and Cooperation in the Validation of Alternative…



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development and recommendation of international test guidelines, and the dissemination of AMs in and out of Korea.

The KoCVAM’s validation workflow can be summarized into the following consecutive steps:

1. Test method developer/proposer: Submission to KoCVAM of a candidate

AM and validation study proposal;

2. KoCVAM: Review of the proposed AM, decision whether or not to initiate a

validation study on the proposed method, and establishment of an ad-hoc

Validation Management Team (VMT), including experts in chemistry and

biostatistics;

3. VMT: Drafting of a project plan for the validation study, establishment of test

chemicals and biostatistics teams, selection of test chemicals (proposed by test

chemicals team), approval of participating laboratories and approval of the test

method’s protocol/SOP;

4. Lead laboratory: Transfer of the proposed test method to the participating

laboratories and finalization of the test method’s protocol/SOP (if required);

5. KoCVAM: Distribution of coded test chemicals to the participating

laboratories;

6. Participating laboratories: Proficiency testing of coded test chemicals followed by intra- and inter-laboratory validation (assessment of reproducibility

and predictive capacity) conducted by the lead laboratory and other participating laboratories;

7. KoCVAM: Collection of data and QA audit on data and study documentation;

8. Bio-statistics team: analyses and evaluation of the data and drafting of a statistics report;

9. VMT: Preparation of a validation study report (the VMT can propose an additional study if found necessary);

10. KoCVAM: Establishment of a Peer Review Panel;

11. Peer Review Panel: Peer review of the study on the basis of the validation

study report and preparation of a peer review report (the Peer Review Panel can

propose an additional study if found necessary);

12. KoCVAM: Evaluation of the peer review report, decision whether or not to

propose the method for regulatory use and organization of an ad-hoc Regulatory

Recommendation Team;

13. Regulatory Recommendation Team: Provide recommendations based on the

peer review report;

14. KoCVAM: Recommendation of the test method to regulatory authorities.

Korea also participates in several international validation studies and peerreviews coordinated by ICATM partners (Table 14.1). The process usually starts

with an ICATM organization making a formal request to KoCVAM for Korean

experts and/or laboratories to join an international validation study or peer-review

panel. KoCVAM then notifies relevant national academic institutions, research

institutes, GLP facilities, CRO or other laboratories and requests for applications.



364



J. Barroso et al.



Table 14.1 Participation of KoCVAM/Korean experts/Korean laboratories in international

validation studies and peer-reviews of AMs

Leading organization

NICEATM/ICCVAM



Endpoint

Endocrine

disrupter

screening



Ocular toxicity

EURL ECVAM



Skin sensitization



JaCVAM



Genotoxicity

Ocular toxicity



Phototoxicity

Skin sensitization



Teratogenicity

NC3Rs



Inhalation toxicity



EDQM



Biological test



Test method

CertiChem

MCF-7 cell

proliferation assay

BG1Luc Estrogen

Receptor

Transactivation assay





Short Time

Exposure assay

KeratinoSens,

DPRA and h-CLAT

In vitro Comet assay

SIRC cytotoxicity

test

Vitrigel-EIT method

ROS assay

IL-8 reporter gene

assay

Vitrigel-SST method

Hand1-Luc EST

assay

Fixed concentration

procedure for acute

inhalation study

In vitro acellular

pertussis vaccine

assay



KoCVAM activities

Validation study



Peer Review Panel



Reference chemicals

international working

group

Peer Review Panel

Peer Review Panel

Validation study, VMT

Validation study, Peer

Review Panel

VMT

VMT, Peer Review

Panel

VMT, Peer Review

Panel

VMT

VMT

Collaborative study



Collaborative study



All applications are reviewed by KoCVAM to assess the qualifications of the

expert(s) or lab(s) and the selected ones are then nominated/recommended to the

ICATM partner.

Korea joined the OECD in 1996. Since its establishment, KoCVAM has constantly adopted OECD TGs in Korea so that AMs can be widely used by academia

and industry in the safety evaluation of cosmetics. Indeed, KoCVAM directly supports the implementation and application of accepted OECD TGs in the area of

cosmetics. This is achieved by first optimizing the test guideline and its implementation in a laboratory by conducting the test at KoCVAM. KoCVAM then prepares

a draft national test guideline, solicits public comments, and finally makes a recommendation to regulatory authorities. KoCVAM is thus playing a leading role in promoting regulatory use of AMs in Korea. The evaluation and acceptance of the new

test guideline is done by the Cosmetics Evaluation Division of MFDS. In Korea, 11

AMs are officially accepted by the MFDS from OECD alternative TGs (Table 14.2).



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Table 14.2 MFDS acceptance for cosmetics

Test method

In vitro 3T3 NRU phototoxicity test

Skin sensitization: Local Lymph

Node Assay

Acute oral toxicity—Fixed

Dose Procedure

Acute oral toxicity—Acute Toxic

Class Method

Skin absorption: in vitro method

Bovine Corneal Opacity and

Permeability test method

Skin sensitization: Local Lymph

Node Assay: DA

Skin sensitization: Local Lymph Node

Assay: BrdU-ELISA

In vitro skin irritation: Reconstructed

human Epidermis test method

Isolated Chicken Eye test method

Acute oral toxicity—Up-and-Down

Procedure (UDP)



International acceptance

OECD TG 432 (2004)

OECD TG 429 (2007)



National

acceptance

2007

2007



OECD TG 420 (2002)



2008



OECD TG 423 (2002)



2008



OECD TG 428 (2004)

OECD TG 437 (2009)

OECD TG 442A (2010)



2009

2011

2014 (revision)

2013



OECD TG 442B (2010)



2013



OECD TG 439 (2010)



2014



OECD TG 438 (2009)

OECD TG 425 (2008)



2015

2015



Korea has a very active (science) policy towards AMs for chemical testing and is

spending considerable funding on test method development and validation. The

budget over the last 7 years amounts to 8.5 million US dollars, with funding going

significantly up since 2013 (1.6 million in 2013, 2.2 million in 2014 and 2.2 million

in 2015). Currently, KoCVAM is validating five test methods: two “me too” skin

irritation test methods (the MCTT KeraSkin and the Tego Neoderm-ED); a

non-radioactive LLNA based on flow cytometry (BrdU) for skin sensitization testing (using the Performance Standards of OECD TG 429); a method using inflammatory mediators (IL1a and IL6) for predicting skin sensitization; and a reconstructed

human cornea-like epithelium (MCTT HCE model) for eye irritation testing. Several

facilities within Korea are conducting AMs and participating in validation studies

forming a national network of validation laboratories, including MFDS/NIFDS, the

Korean Testing and Research Institute (KTR), the Seoul National University

Hospital Biomedical Research Institute, the AMOREPACIFIC R&D center, the

Biotoxtech Co. and the Catholic University of Daegu GLP center.



3.6



Points in Common and Differences Between the Different

ICATM Organizations



Table 14.3 summarises the points in common and the differences between the different international organizations that are currently members of ICATM and that

were described in the previous paragraphs.



Yes



Yes, EURL ECVAM is

legally entitled to

conduct validation of

alternative methods



Yes



Yes, e.g. participation

in OECD expert

groups and WNT;

development and

coordination of OECD

AOP Knowledge Base;

development of OECD

TGs, GDs and IATA.



Normally through

OECD TGP first.

Adopted OECD TGs

are then translated into

EU Test Methods and

adopted in the EU Test

Methods Regulation

(TMR)



Legislative Mandate

to Validate Methods



Fitting into

International

Requirements/Topics/

Activities



Interaction and

Cooperation with

International

Organizations, e.g.

OECD



Regulatory

Acceptance



Yes



Promoting 3Rs



Chemical Safety



EURL ECVAM



Activities



NICEATM



Yes, through

ICCVAM



Yes, through

ICCVAM



NICEATM is part of

the NTP overseen

by the NIEHS

(NIEHS is 1 of the

27 NIH institutes)



Yes



Yes



Regulatory acceptance has to fit with

national/federal agencies needs as they

trigger the process of TM evaluation.

Validation at the OECD level is not

mandatory but additional



Yes, the

U.S. NC for the

OECD is part of

ICCVAM



Yes



No, ICCVAM

works on

request by

federal agencies



Yes



Yes



ICCVAM



Table 14.3 Mapping of ICATM partners activities, workflow and functioning

JaCVAM



Through OECD TGP



Yes, focus on OECD

TGP. Japan has several

National Coordinators. The

NCs are organized by

ministries (Ministry of

Health, Ministry of

Environment…).

– A SPSF has to be agreed

by all NCs

– NCs hold a coordination

meeting before the WNT

meeting



Yes



JaCVAM works for the

NIHS which is overseen

by the MHLW



Yes



Yes



KoCVAM



Through OECD TGP



Yes, NIFDS has an

OECD NC



Yes



KoCVAM is

established under

‘Laboratory Animal

Act of 2008’



Yes



Yes



Health Canada



Through OECD TGP; HC

and Environment Canada

share the responsibility of

regulatory acceptance,

however the Canadian NC

at the OECD is from HC



Yes, HC has decided to

base its recommendations

on the OECD TGP



Yes



Health Canada has a

broad mandate to protect

health and acts primary as

a regulator. HC is a

federal department and is

a regulatory body



Yes



3Rs considered but HC

not focused on it



366

J. Barroso et al.



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