Questions and answers about the proposed regulation of blood under the ANZTPA
February 2007
What is the definition of blood?
The term Blood refers to:
- whole fresh blood
- blood components
- blood products (for therapeutic use)
What is the definition of a biological?
Biologicals are therapeutic products which are derived from a biological or living source. Examples of biologicals include blood and blood products, vaccines, and therapeutic products derived from cells and tissues. The precise definition of a biological in the ANZTPA is still under review, but it will be harmonised with similar definitions used by international regulators in Europe and North America.
How are blood and biologicals currently regulated in Australia and New Zealand?
New Zealand and Australia have regulatory measures in place to ensure that blood and blood products meet safety standards including:
- Blood components are regulated through facility licensing in both countries.
- Plasma derivatives and Biopharmaceuticals are regulated as medicines in both countries.
- Vaccines are regulated as medicines in both countries, except when exempt through medical practice provisions.
- Cells and tissues have complex arrangements in Australia. They are mostly unregulated in New Zealand (some are regulated as medicines).
What type of regulation is proposed under the ANZTPA?
It is proposed that the Authority would have common standards for the donation of blood, blood collection and blood products such as plasma.
The key aspects of the proposed regulation of blood include:
- pre-market assessment of products
- licensing of products
- compliance with standards and audits
- licensing of manufacturers
- post-market surveillance
The proposals apply a level of regulation in line with potential risks to public health and safety by balancing the possible risks of the use of blood and blood products with the potential benefits. The proposed regulatory framework ensures consumers have sufficient and accurate information to select and use therapeutic products safely and effectively.
What is the definition of a blood kit?
A blood kit could contain for example whole fresh blood, blood components or blood products along with a medical device for applying or administering the product. The components of the kit would need to be licensed under the ANZTPA. An example of a blood kit would be a blood clotting factor, such as Factor VIII, when it was supplied with an infusion set for intravenous administration.
What expertise will the members of the Expert Advisory Committee on Biologicals have and how will they be appointed?
It is proposed that the Expert Committee will be comprised of people with a breadth of appropriate expertise from both countries. This will include expertise in blood and blood products and other biologicals The Ministers on the Ministerial Council will appoint the members.
Will there be harmonisation of GMP codes of practice for blood products?
Yes, the intention is that there will be a single Code of GMP for blood.
URL: http://www.anztpa.org/bt/qablood.htm