https://mhrainspectorate.blog.gov.uk/2019/02/21/being-signed-up-to-the-oecd-mutual-acceptance-of-data-agreement-is-anything-but-mad/

Being signed up to the OECD Mutual Acceptance of Data agreement is anything but MAD!

2 heads, silhouetted against a world map, engaged in dialogue

Some of you may be asking why is that? What is it and who is it for? I am a Lead Senior Inspector at the MHRA and part of the UK Good Laboratory Practice Monitoring Authority (GLPMA).  What I hope to achieve with this blog post is to answer all those MAD questions.

Let’s start with the ‘who?’ OECD is The Organisation for Economic Co-operation and Development.  Anyone working for a GLP test facility should be aware that it is the Principles of GLP (as recommended by the OECD Council in 1981) that form part of the UK Good Laboratory Practice Regulations (SI3106).  This makes compliance with the Principles of GLP a legal requirement in the UK.

The members of the OECD working group on GLP are made up of the heads of the monitoring authorities. The work of this group is very important in the world of GLP, where one of the main aims is to promote global harmonisation on how the GLP Principles, including consensus and advisory documents, are interpreted and applied.

Why is it a good idea for the United Kingdom to be part of the OECD MAD framework? Put simply, it:

  • saves time and money
  • avoids duplication of effort
  • reduces barriers to trade

For a better understanding of how this works check out this OECD link.

The UK is a signatory to the OECD’s MAD agreement at a national level. What this means is that the UK’s decision to leave the European Union will not impact on international obligations to accept GLP data from UK GLP facilities. Hold that thought about the UK leaving the EU, all will be made clear.  In the meantime, let me tell you a bit more about what mutual acceptance of data actually means, and why it makes sense.

The MAD agreement is made up of 3 OECD council acts. These acts contain the decisions of the OECD Council, which is the OECD governing body.

Council Act C(81)30 - Decision concerning Mutual Acceptance of Data in the Assessment of Chemicals

This act contains two distinct parts.  Part I is mandatory and requires that data generated in a member country in accordance with OECD Test Guidelines and Principles of Good Laboratory Practice (GLP) shall be accepted in other member countries for assessment purposes and other uses relating to the protection of human health and the environment. Part II recommends countries apply the OECD Test Guidelines and the OECD Principles of GLP in their testing of chemicals.

Council Act C(89)87 - Decision-Recommendation on Compliance with Principles of GLP

This sets out the procedures and institutional arrangements to be followed by countries for the monitoring of compliance with GLP. These procedures and arrangements must be in place for the data generated by the GLP facilities located in the country to be recognised as GLP compliant and accepted by other OECD MAD-adherent countries.

Council Act C(97)114 – Decision concerning the Adherence of Non-Member Countries to the Council Acts Related to Mutual Acceptance of Data in the Assessment of Chemicals – which is an internal, procedural act, that allows non-OECD members to join the MAD system by adhering to C(81)30 and C(89)87 and sets out a procedure for this purpose.

What is crucial to point out is that these council decisions are legally binding on all member countries.

In summary, if a country is a signatory to the OECD MAD agreement, GLP facilities within the country have the opportunity to become part of the country’s GLP compliance monitoring system. GLP facilities that are participants in national GLP monitoring systems can then conduct GLP studies, the results of which shall be accepted in other member countries for purposes of assessment and other uses relating to the protection of public health and the environment.

Consequently, the UK’s withdrawal from the EU will not impact on the acceptance of GLP data generated in UK facilities by European or other international regulatory receiving authorities.

 

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