Oecd mutual Acceptance of Data System Factsheet What is oecd mutual Acceptance of Data (mad) system?

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OECD Mutual Acceptance of Data System Factsheet
What is OECD Mutual Acceptance of Data (MAD) system?

  1. MAD was established in 1981 under the Organisation for Economic Co-operation and Development (OECD) Council Act. It states that data generated in an OECD member state in accordance with OECD Test Guidelines and Principles of Good Laboratory Practice (GLP) will be accepted in other member countries for assessment purposes and other uses relating to the protection of health and the environment.

  1. Non-member states can gain acceptance into the system if they demonstrate that their test facilities produce safety data of comparable rigor and quality. This removes the need for costly and labour-intensive re-testing. It also makes it possible for producers in OECD countries to have safety tests for their chemicals done in MAD-compliant non-OECD states.

Which OECD and Non-OECD countries are MAD-compliant?
OECD Countries

  1. Australia

  1. Korea

  1. Austria

  1. Luxemburg

  1. Belgium

  1. Mexico

  1. Canada

  1. Netherlands

  1. Czech Republic

  1. New Zealand

  1. Denmark

  1. Norway

  1. Finland

  1. Poland

  1. France

  1. Portugal

  1. Germany

  1. Slovak Republic

  1. Greece

  1. Spain

  1. Hungary

  1. Sweden

  1. Iceland

  1. Switzerland

  1. Italy

  1. Turkey

  1. Ireland

  1. United Kingdom

  1. Japan

  1. United States

Non-OECD Countries

  1. Israel

  1. South Africa

  1. Slovenia

  1. Singapore

Why is it important for Singapore to gain OECD-MAD membership?

  1. With OECD-MAD membership, biomedical companies in Singapore can enjoy better market access and cost savings when exporting to the other member countries. Pre-clinical research data from Singapore’s GLP-compliant companies will be accepted and recognised in these countries. This removes the need for costly and labour-intensive duplicative testing overseas.

  1. Among the OECD-MAD members are many developed countries like Australia, Japan, the UK and US, which are key biomedical export markets for Singapore. Easier access to these markets will boost the growth of the biomedical sciences sector and enhance Singapore’s position as a medical hub in the region.

How did Singapore gain OECD-MAD membership?

  1. Participation in the MAD system begins with provisional adherence by the non-member who must accept data generated under MAD conditions from member countries. During this time, Singapore worked with the OECD countries to make our GLP programme acceptable to members.

  1. SPRING Singapore, together with the Agri-Food & Veterinary Authority (AVA), National Environment Agency (NEA), Health Sciences Authority (HSA), and Economic Development Board set up a committee to manage the GLP programme.

  1. The committee set up a framework to manage the registration of our GLP facilities, develop a quality management system, and train staff and inspectors. Seminars and workshops were also organised to raise awareness and prepare the industry for the programme. The committee members also attended OECD GLP Working Group meetings to garner support for Singapore’s GLP programme.

  1. The OECD Council then sent a team of experts from three OECD member countries to evaluate Singapore’s GLP compliance monitoring programme on-site. Based on the results, the OECD Council accepted Singapore as a full MAD-adherent member, with the same rights and obligations as the OECD countries.

What does MAD-adherent status mean for testing facilities in Singapore?

  1. Research data from compliant facilities under SPRING’s GLP programme is automatically recognised in all MAD-compliant OECD and non-OECD member countries.

Good Laboratory Practice (GLP) Programme Factsheet
What is Good Laboratory Practice (GLP) Programme?

  1. Introduced in June 2006, the Good Laboratory Practice, or GLP, Programme is a quality management system that reviews a research laboratory’s processes and conditions under which its non-clinical studies are planned, performed, monitored, recorded, reported and archived. The system can be applied to the risk assessment of chemicals for registration of products.

  1. The GLP Programme promotes the quality and validity of test data and ensures that test results are reliable and repeatable. In addition, the programme ensures that studies are auditable so that they can be reconstructed in their entirety from the archived data at a later stage.

  1. The programme was developed jointly by SPRING, the Agri-Food and Veterinary Authority (AVA), Economic Development Board (EDB), Health Sciences Authority (HSA) and the National Environment Agency (NEA).

  1. In Singapore, the relevant registration authorities are:

    1. Health Sciences Authority (HSA) for pharmaceuticals industry

    2. Agri-Food and Veterinary Authority (AVA) for veterinary biologics and agricultural chemicals

    3. National Environment Agency (NEA) for pesticides and industrial chemicals

  1. The basic document dealing with the GLP is the OECD Principles of Good Laboratory Practice produced by the OECD GLP Working Group. More information on this is available at http://www.oecd.org/ehs.

Who should apply to the programme?

  1. The GLP programme is applicable to research laboratories in the pharmaceutical, pesticides, veterinary drug products and industrial chemicals industries as well as contract research organisations. Contract research organisations provide research services for multinational corporations, or MNCs, which may not have their own research departments.

  1. The GLP principles can be applied to the conduct of non-clinical health and environmental safety studies of products such as pesticides, cosmetics, pharmaceutical or drugs, food and feed additives, and industrial chemicals. Non-clinical studies cover physical-chemical testing, toxicity studies, environmental toxicity, residue studies, and the analytical chemistry studies.

  1. The programme does not include the conduct of clinical studies such as pharmacokinetic and efficacy studies. However, some registration authorities may require a demonstration of the quality of test data from clinical studies. In Singapore, this is best demonstrated by the testing laboratory accredited under the Singapore Laboratory Accreditation Scheme, or SINGLAS, in areas such as medical testing or chemical and biological testing.

What are the benefits of GLP registration?

  1. GLP registration is an assurance to regulatory authorities that the data from research laboratories are a true reflection of the study results and are thus reliable for making risk/safety assessments.

  1. Companies interested to enter into markets, like the European Union, are encouraged to apply for GLP registration. These countries require non-clinical studies to be conducted in compliance with the GLP principles. GLP-compliance will remove the need for expensive duplicative safety tests and reduce time to market for new products.

How can testing facilities apply for SPRING’s GLP programme?

  1. A facility seeking recognition for compliance should apply to SPRING, stating its proposed scope of recognition and type of studies. It has to provide information in the following areas:

  1. SPRING will do a documentation review before conducting an on-site assessment. The facility must also complete at least one GLP-compliant study before the assessment, which will be used as the basis for the on-site assessment.

  1. The on-site assessment will be done by a SPRING staff who may be accompanied by technical experts in various fields as decided by SPRING. The assessment may take from one to five days, depending on the scope and size of the facility.

  1. Once the facility has met all the criteria in accordance with the GLP principles, SPRING will issue a Certificate of Registration detailing the types of studies for which the facility is GLP-complaint. The time taken for a facility to be registered may range from three to six months, depending on the type and nature of the studies as well as results of the assessment.

  1. The cost of a typical GLP registration is about $7,500. The fee includes application, documentation review, facility inspection, study audit and annual certificate fee.

  1. A study audit will be done annually and a re-inspection will be conducted every two years.

  1. Facilities which are interested in the GLP programme can contact Enterprise One Hotline at tel : 6898 1800 or email enterpriseone@spring.gov.sg

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