TGA biologicals framework newsletter, Issue 4, November 2010

On this page: Welcome | Updates and progress on the biologicals framework | TGA organisational structure | Further information

Welcome

The purpose of this newsletter is to update you on the development of the new Biologicals Framework. Of particular note are:

• A consultation paper on proposed changes to the Regulations;
• Nationwide information sessions on the above; and
• A draft Code of GMP and five proposed Therapeutic Goods Orders

Updates and progress on the biologicals framework

Legislation

On 31 May 2010, the Therapeutic Goods Amendment (2009 Measures No 3) Bill 2009 (the Bill) received Royal Assent. The Bill makes a number of amendments to the Therapeutic Goods Act 1989 (the Act), including the implementation of a new regulatory framework for biologicals. The TGA now has until 31 May 2011 to implement the Biologicals Framework. Once the framework has been implemented, by law, all products within the scope of the framework will need to comply with the requirements made under the new legislation, subject to relevant transition arrangements.

Regulations

Amendments to the Therapeutic Goods Regulations (1990) (the Regulations) in relation to biologicals are currently being drafted. A consultation paper is currently available which details specific changes as required for the implementation of the Biologicals Framework. The consultation includes:

• the biologicals classification system
• separate and distinct criteria for biologicals
• clinical trial requirements
• exemptions in relation to medical practitioners
• exceptional release scheme
• adverse event reporting timeframes
• patient information for biologicals.

Information sessions on proposed amendments to the Regulations

To provide stakeholders with an opportunity to clarify any issues in relation to the Biologicals Framework, the TGA will be holding information sessions in the last two weeks of November to align with the above consultation on proposed amendments to the Regulations. Dates for information sessions are as follows:

These information sessions will also cover the Fees and Charges for Biologicals, which will be the subject of an upcoming consultation in November 2010.

Interested stakeholders are invited to register to attend one of the information sessions by submitting the Information Session: Registration Form by no later than COB 12 November 2010.

Product standards and Code of GMP

The draft Code of GMP and five proposed Therapeutic Goods Orders for blood and blood components, human tissues and human cellular therapies were available for consultation from 7 December 2009 until 12 February 2010. Details of the consultation are available in the historical/closed consultations section of the TGA website.

The TGA received a strong response from stakeholders, and these submissions (unless marked confidential) are now available for viewing under the blood and tissues section of the TGA website.

The comments were reviewed by the TGA and common areas of stakeholder concern were identified, including:

• timing and requirements for the examination and consent of living donors
• disease and age exclusion criteria for living donors
• timing and requirements for sampling and testing of donors
• assessment of microbial contamination and minimisation of bioburden
• requirements for transport, storage, quarantine and banking
• standards for plasma for fractionation.

Consideration of these matters has resulted in significant revisions to all five standards. Given the significant changes, the Therapeutic Goods Committee Subcommittee on Biologicals agreed that it would be necessary for the revised standards to undergo a second round of stakeholder consultation. Minor revisions that do not require further consultation have been made to the Code of GMP.

Consultation on the revised Orders and a proposed new Labelling Order for biologicals is expected to commence in November 2010.

TGA organisational structure

The Therapeutic Goods Administration (TGA) officially launched a new organisational structure on 1 July 2010. This new structure will support the TGA's delivery of appropriate, consistent, effective and efficient regulation into the future. Under the new structure, the former 'Blood and Tissues Unit' has been integrated into the new Biological Sciences Section of the Office of Scientific Evaluation.

More information on the new structure can be found on the TGA Website.

Further information

If you have any queries or would like further information please contact the TGA at bloodandtissues@tga.gov.au or on: 1800 678 799.

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