OECD GLP Studies in Thailand – Get ready?

Siripan Wongwanich

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Disclaimer

The opinions that are expressed today are those of the

author and not necessarily those of the Department of

Medical Sciences

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Outline

OECD Council Acts on GLP

GLP activities carried out by national related agencies

• Government agencies

• Test facilities

Discussion & conclusion

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OECD Principles of Good Laboratory Practice

• In 1979 and 1980, an international group of experts established under the Special Programme on the Control of Chemicals developed the “OECD Principles of Good Laboratory Practice” (GLP).

• Principles of GLP were adopted by the OECD Council in 1981.

• Reviewed and adopted by Council on 26th November, 1997

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OECD Council acts on Good Laboratory Practice

1981 Council Decision on Mutual Acceptance of Data in the Assessment of Chemicals [C(81)30/Final]

1989 Council Decision / Recommendation on Compliance with the Principles of Good Laboratory Practice [C(89)87/Final]

1997 Council Decision of Adherence of Non-Member Countries to the Council Acts relating to the Mutual Acceptance of Data [C(97)114/Final]

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1981 OECD Council Decision

An integral part of the 1981 Council Decision on MAD (Annex II)

“Data generated in the testing of chemicals in OECD Member

country in accordance with OECD Test Guidelines and OECD

Principles of Good Laboratory Practice shall be accepted in other

Member countries for purposes of assessment and other uses

relating to the protection of man and the environment.”

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Requirements for GLP studies

• GLP covers regulations that are intended to ensure the quality and integrity of the data in a non-clinical laboratory study.

• GLP is the law

- They are not ideas

- They are not governmental philosophy

- They are not guidelines

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OECD Council Decision of Adherence of Non-Member Countries to the Council Acts relating to the Mutual Acceptance of Data (MAD)

GLP compliance test facilities

GLP Compliance Monitoring Authority

Sponsor

Regulator

Industrial Chemicals, Pharmaceutics, Food additives,

Feed additives, Vet drug, Cosmetics, Pesticides (chemical/bilogical pesticides, GMO, biocides, insecticides)

Inspection

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Involving organizations in GLP

Regulator

(Regulations)

GLP-Test Facility GLP-CMA

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A requirement for GLP study by Thai regulators

Notification of Thai FDA requires GLP and GCP in a

registration of new drugs, generic drugs (issued in Dec 2008).

Department of Agriculture: Notification of Hazardous

Chemicals B.E. 2552 (Nov 2009) and B.E. 2557 (Mar

2014) requires a safety testing data of pesticide, biocide,

insecticide from a GLP compliant test facility.

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Thai GLP Compliance Monitoring Authority

• Department of Medical Sciences, Ministry of Public Health.

• Scopes of registration: pharmaceutics, cosmetics, veterinary

drug, food additives and house-hold chemicals.

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• Application • Initial visit (optional) • Documentation review • On-site Inspection – Study audits, inspection of quality system, review of records, discussions with key personnel, observation of relevant activities • Inspection report with recommendations • Approval decisions • Registration of facility

Registration Process

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Thailand’s GLP journey to adherence to OECD Council Acts Related to MAD

Information from the OECD Secretariat..(20 Mar 2008)

• Ad-hoc invitations to attend OECD activities

- OECD Working Group on GLP (from 2008 - present)

- OECD Training Courses for GLP Inspectors

(2009, 2013)

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Thailand’s GLP journey to MAD

• 12 July 2010 - Letter from the Thai government to OECD

(Cabinet/Ministerial level)

• 20 September 2010- Council invited Thailand to provisionally adhere

to MAD Council Acts, initially for three years

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Building capacities for industries

• Bilateral cooperation with OECD countries

• GLP implementation workshops

2007-2010 - New Zealand (Mr. Barry Ashcroft)

- Japan (Mr. Nobusama Nakashima, Dr. Toshihiko Asano)

- Finland (Dr. Katarina Rautalahti, Dr. Jouni Raisenen

- US EPA (Ms. Francisca Liem, Mr. Daniel Myers)

2013-2014 – Malaysia (September 2013), Netherlands (July 2014)

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Thailand’s GLP journey to MAD

• Mutual Joint Visit by OECD team (Spain, Belgium, India)

• On-site Evaluation (Jan 2012, follow up in December 2015)

• Focus on the compliance monitoring programme (CMA)

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GLP Compliant Test Facility: BE studies

Thailand

1. Internationnal Bio Service Co., Ltd.

2. Medica Innova Co., Ltd.

3.Bio-Innova & Synchron Co.,Ltd.

4. Government Pharmaceutical Organization

5. Faculty of Pharmacy, CMU

6. All Research Co., Ltd.

7. Pharma Nueva Co., Ltd.

India

1. Mylan Laboratories Ltd.

2. Lambda Therapeutic Research Ltd.

3. Clinigene International Ltd.

4. Cliantha Research Limited

5. Axis Clinicals Limited.

6. Cadila Pharmaceuticals Limited.

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No GLP Compliant Test Facility on Toxicology test

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A potential to be GLP Facilities National Laboratory Animal center of MU Chulabhoon Research Institute Thailand Institute of Scientific and Technological research

Why?

- GLP study is about the law. The data being used for the

legislation of novel chemicals/chemical products.

- it is a business on generation of chemicals safety

assessment data that quality data has an important

international dimension.

- The cost for GLP studies are about 3X higher than that

of non-GLP studies.

- Work culture has to be changing a lot in order to

implement the Principles of GLP.

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Toxicology test

• Scientific issues: necessity for high-to-low dose extrapolation, limitations of genetically homogeneous animal strains, uncertainty of interspecies comparisons

• Practical problems: cost and time and inability to test large numbers of chemicals

• Ethical: number of animals are required to undertake a full testing regimen of all chemicals - pain, distress

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Alternative methods

new approaches to assessing the hazards of chemicals - using toxicity testing based on human cell lines - genomics, proteomics, metabolomics, computational biology, and in silico (computer-based)

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CMA

Test Facilities

Associations

Industries

Regulators

Implement GLP regulations

Investment /development

Needs involvement & engagement by stakeholders

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Country A Country B

Regulatory Authority

GLP Monitoring Authority

GLP Monitoring Authority

Submits data

Inspection and / or Study Audit

Report

Information

Request

Information

Information Requests information

on GLP compliance

status of the test facility

or requests study audit.

Recommendation from the Working Group on GLP following

the next follow up of the on-site evaluation…………………… adherence to OECD Council Acts Related to MAD

Test Facility

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Benefits • Eliminates non-tariff trade barriers • Increases international market access • Increases regulatory confidence in data • Reduces time to market for new products • Avoids testing duplication • Saves resources especially time and money

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