Overview of Regulatory
Sourcing, movement, handling, storage, and traceability of serum products are governed by strict regulations globally. ISIA works to support members through this complex and evolving landscape.
What is regulatory?
Sourcing, movement, handling, storage, and traceability are governed by strict regulations globally for serum products also known as Animal By-Products (ABPs). Controls are implemented globally and govern sourcing through to end product traceability.
While similar sanctions are imposed around the world, they do differ between markets and are enforced by market-specific biosecurity authorities on a risk-led basis. Concerns arise when disease outbreaks occur that limit the access to materials no longer having free movement globally.
At a high regulatory level, when faced with market-specific or wider regulation changes, ISIA leverages our industry network, global competent authorities, working groups, and associations such as Med Tech to influence how ABPs are considered and controlled.
How does the ISIA regulatory team support you?
Our commitment to regulatory excellence supports members through every step of compliance, advocacy, and education across the global serum industry.