It’s no secret that Brexit is weighing heavily on everybody’s minds at the moment. One of the major questions being asked in our industry is “how will Brexit affect the acceptance of non-clinical study data?”. In this blog post you’ll get our fully-informed answer.
We start with an overview of the OECD, and a summary of a recent public statement from the Medicines and Healthcare Products Regulatory Agency (MHRA). We cover the acceptance of Good Laboratory Practice (GLP) worldwide data from UK labs. Plus, you’ll hear from Envigo’s Chief Scientific Officer, Lee Coney, on the recent news. (Spoiler alert: if you’re an Envigo customer, you have nothing to worry about.)
Remind me, what is the OECD?
The Organisation for Economic Co-operation and Development (OECD) was founded in 1961. It has 36-member countries, including the UK and many of its European partners. The OECD aims to promote world trade and economic progress.
How does the OECD define Good Laboratory Practice (GLP)?
“The Principles of Good Laboratory Practice (GLP) have been developed to promote the quality and validity of test data used for determining the safety of chemicals and chemical products.
These Principles of Good Laboratory Practice apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals.
The principles have been created in the context of harmonizing testing procedures for the Mutual Acceptance of Data (MAD).”
The issue of data quality has an important international dimension. If regulatory authorities in countries can rely on safety test data developed abroad, duplicate testing can be avoided, and costs saved to government and industry.
Moreover, common principles for GLP facilitate the exchange of information and prevent the emergence of non-tariff barriers to trade, while contributing to the protection of human health and the environment.
How is the OECD an important player in the GLP world?
The members of the OECD GLP Working Group consist of the heads of the monitoring authorities. They work hard to harmonize the interpretation and application of GLP principles across the globe and promote the quality of the data presented to Regulatory Authorities.
The Principles of GLP were recommended by the OECD Council in 1981, updated in 1997 and are enacted into UK law through the UK Good Laboratory Practice Regulations (SI3106). This means that complying with the Principles of GLP is a UK legal requirement.
The OECD’s MAD consists of three different OECD council acts - each of which is binding on each member state. Including, of course, the UK.
So, why is it important the UK is signed up to MAD?
The three main benefits of the UK being signed up to MAD are that it:
- endorses the quality of the data generated by the UK GLP facilities
- data is accepted in all OECD member countries without the need for multiple inspections by different countries
- stops the UK's efforts being duplicated unnecessarily
What has the MHRA said about OECD MAD and Brexit?
As the MHRA have made clear, the key point is that the UK is signed up at a national level to the OECD’s MAD agreement. This means that:
- UK GLP facilities join the UK's monitoring system for GLP compliance
- UK GLP facilities can run GLP studies. Other member countries will then accept the results for assessment for protecting the environment and public health
- The UK withdrawing from the European Union will not stop UK-generated GLP data being accepted by international regulatory receiving authorities, through the OECD MAD
What does this news mean for Envigo customers?
We put this question to Chief Scientific Officer, Lee Coney. Lee has been with Envigo for 14 years, during which time he’s helped thousands of companies around the world develop their therapeutic products. More recently, Lee has chaired Envigo’s Brexit taskforce, a multidisciplinary team from across the business, who have prepared the business for a variety of Brexit outcomes.
He said: “The main message to take away is that the Brexit decision will not affect GLP data, and this fact has been endorsed fully by the UK government.”
“This is good news,” Lee continued, “for both us and our customers. All of Envigo’s UK labs comply with GLP, therefore, our customers know that their programs of work with us won’t be affected by Brexit - however the politics play out.”
Do you have any Brexit related questions we can help with? Please email us at email@example.com.