The OECD Mutual Acceptance of Data (MAD) system is a multilateral agreement which saves governments and chemical producers over EUR 309 million every year by allowing the results of a variety of non-clinical safety tests studies done on chemicals and chemical products such as medicines, industrial chemicals and pesticides to be shared across OECD. The OECD MAD system requires that testing be carried out using OECD standards for test methods (OECD Test Guidelines) and for data quality and integrity (OECD Principles of Good Laboratory Practice - GLP).
A non OECD country can also participate in the MAD system, beginning first as a provisional adherent, and then, once the national GLP Compliance Monitoring Programme of that country has been successfully evaluated by OECD, they can become a full adherent.
What are provisional and full adherence to MAD?
Participation in the MAD system begins by provisional adherence, during which time the non-OECD member candidate country works with OECD and full MAD adherents to implement its GLP compliance monitoring programme. Provisional adherence to the OECD MAD system means that the candidate country must accept data from OECD countries and full adherents to MAD if such data was generated under MAD conditions. After a team of three experts, designated by the OECD Working Group on GLP, has conducted an on-site evaluation of the provisional adherent’s GLP compliance monitoring programme, the team reports the results to the Working Group. If the Working Group agrees that the pvosional adherent has fully implemented the Council Acts related to MAD, the OECD Council can invite the country to become a full adherent to the Council Acts on MAD, with the same rights and obligations as OECD countries.
Full Adherence to MAD
Once a country is a full adherent to MAD, it must accept data generated under MAD conditions from OECD and other full MAD adherent countries. Equally, all OECD countries as well as full and provisionaladherents to MAD must accept their data provided that the data have been generated under MAD conditions. Thus the MAD system prevents potential non-tariff trade barriers between non-OECD countries adhering to the MAD system and OECD countries for marketing chemicals that would have been caused by different standards and verification procedures. It also opens up the possibility for producers in OECD member countries to have safety tests for their chemicals undertaken in adhering non-OECD- economies.
Non-OECD member countries: Argentina*, Brazil, India, Malaysia, Singapore, South Africa and Thailand are full adherents to MAD.
Countries participating in the MAD system are only required to accept test study data if the product being tested is within the scope of the national GLP compliance monitoring programme. The scope of a monitoring programme can include non-clinical safety testing of test items contained in:
i) pharmaceutical products;
ii) pesticide products;
iii) cosmetic product;
iv) veterinary drugs;
v) food additives;
vi) feed additives; and
vii) industrial chemicals
If the scope of a compliance monitoring programme does not include one of these products (e.g., cosmetics), then other countries are not required to accept test study data on cosmetics from that countrys. The scope of all national GLP compliance programmes within the MAD system can be found here.
Currently, while the majority of OECD countries have GLP compliance monitoring programmes which have been evaluated by OECD, not all countries have been evaluated. (This list indicates whether an OECD member country has a monitoring programme which has been evaluated). OECD countries and adherents to MAD are only required to accept data from countries whose monitoring programmes have been evaluated.
There is a step-wise procedure for non-OECD economies to become full adherents to MAD.
1) First, the non-OECD-member economy’s government confirms to OECD that it will provisionally adhere to MAD. That is, it agrees to accept, for assessment purposes, non-clinical test study data generated in the testing of chemicals with OECD Test Guidelines and in compliance with OECD Principles of Good Laboratory Practice from countries adhering to the OECD Council Acts on MAD. However, OECD countries and full adherents to MAD are not obligated to accept data for assessment purposes from the provisional adherent. This is because the provisional adherent’s GLP Compliance Monitoring Programme (CMP) has not yet been successfully evaluated by OECD.
2) Second, as the provisional adherent is setting up a GLP CMP, it is invited to join the OECD Working Group on GLP meetings and training courses, and to serve as an observer in on-site evaluations of other MAD countries
3) Third, once the provisional adherent has fully developed its GLP CMP according to OECD guidance, an on-site evaluation visit is carried out. Based on the outcome of this visit, if the OECD concludes that the provisional adherent’s GLP Compliance Monitoring Programme is in accord with the OECD Council Acts on MAD, the country becomes a “full” adherent to MAD. As a full adherent, all non-clinical test study data generated in that country according OECD Test Guidelines and OECD Principles of Good Laboratory Practice must be accepted for assessment purposes in all OECD member countries and MAD adhering non-OECD-member economies.
If a country wishes to join MAD, who should they contact for more information?
Please contact: Eeva Leinala - [email protected]