Federal Register of Legislation - Australian Government

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MP1/2013 Determinations/Health as made
This instrument determines principles to be observed in the manufacture of therapeutic goods for use in humans.
Administered by: Health
Registered 28 May 2013
Tabling HistoryDate
Tabled HR30-May-2013
Tabled Senate17-Jun-2013
Date of repeal 01 Jan 2018
Repealed by Therapeutic Goods (Manufacturing Principles) Determination 2018

EXPLANATORY STATEMENT

 

Subject:     Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013

Section 36, Therapeutic Goods Act 1989

 

OUTLINE

Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013 (MP 1/2013) is a Determination made by the Minister under section 36 of the Therapeutic Goods Act 1989 (the Act).

 

The purpose of the Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013 (MP 1/2013) is to:

 

·                revoke Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2007 (MP 1/2007) and Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2009 (MP 1/2009); and

·                replace these with a Determination compiling the requirements of these instruments but with a number of amendments; and

·                to update references to other documents (e.g. in particular, to replace the Australian Code of Good Manufacturing Practice (GMP) for Human Blood and Tissues’ published 28 September 2000 (the 2000 Code of GMP) with the Australian Code of GMP for Human Blood, Blood Components, Human Tissues and Human Cellular Therapy Products dated April 2013 (the 2013 Code of GMP).

 

MP 1/2013 commences on 31 May 2013, however it is important to note that MP 1/2013 sets out transitional arrangements for blood, blood components, plasma, biologicals and haematopoietic progenitor cells whereby manufacturers of these goods would not be required to comply with the 2013 Code of GMP until 31 May 2014 may instead continue with the 2000 Code of GMP.

 

BACKGROUND

The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods for use in humans.   The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

 

Section 36 of the Act empowers the Minister to determine, as required, principles to be observed by manufacturers of therapeutic goods.  These principles are designed to set out the minimum requirements to be observed for the manufacture of therapeutic goods.

 

It is a condition of each manufacturing licence that manufacturers of therapeutic goods comply with the manufacturing principles (subparagraph 40(4)(a)(ii) of the Act refers), and if a holder of a manufacturing licence breaches this (or any other) condition their licence may be suspended or revoked (paragraph 41(1) (a) (viii) of the Act refers).  The Secretary may also refuse to grant a manufacturing licence if satisfied that the applicant for the licence will be unable to comply with the manufacturing principles (paragraph 38(1)(e) of the Act refers).

 

Under subsection 36(2) of the Act, manufacturing principles may relate to any of the matters specified in paragraphs 36(2)(a) – (e) of the Act, including the standards to be maintained and the equipment to be used at manufacturing premises, procedures for quality assurance and quality control and the manufacturing practices to be employed in producing therapeutic goods.

 

MP 1/2013 sets out requirements relating to the procedures to be adopted and the manufacturing practices to be employed in relation to the manufacture of: therapeutic goods (set out in Division 1 of the instrument), blood and blood components, biologicals, plasma and haematopoietic progenitor cells (Division 2 of the instrument) and therapeutic devices (Division 3 of the instrument).

 

MP 1/2013 revokes MP 1/2007 and MP 1/2009, and replaces them with a compilation of those two instruments, with the addition of the following changes to those earlier instruments:

 

·           to update the  definition of haematopoietic progenitor cells to include  haematopoietic progenitor cells that are used for haematopoietic reconstitution, this has been developed by the TGA following public consultation and implementation of the Biological framework;

·           to replace a reference in MP 1/2007 to Therapeutic Goods Order No. 74 - Standard for Blood Components TGO 74 with a reference to Therapeutic Good Order No. 81- Standard for Blood and Blood Components, to reflect that TGO 74 was revoked and replaced by TGO 81 in December 2008;

·           to replace a reference in MP 1/2007 to the “European Agency for the Evaluation of Medicinal Products document “Guideline on the scientific data requirements for a plasma master file (PMF) EMEA/CPMP/BWP/3794/03” with a reference to the European Medicines Agency document “Guideline on the scientific data requirements for a plasma master file (PMF) Revision 1 EMEA/CPMP/BWP/3794/03 Revision 1 (2006)”, principally to reflect the updating of that document since MP 1/2007 was made ; and

·           to replace references in MP 1/2007 to the 2000 Code of Good Manufacturing Practice (the 2000 Code of GMP) with references to the Australian Code of Good Manufacturing Practice (2013) (2013 Code of GMP).

 

The most important of the above changes is the replacement of the 2000 Code of GMP with the more recent 2013 Code of GMP.

 

This has been done for a number of reasons including, principally, to reflect developments since 2000 in manufacturing methods and types of human tissue and cell based therapies in clinical settings.  The making of the 2013 Code of GMP, and its incorporation into this Determination, also reflects feedback from industry that the 2000 Code of GMP was no longer adequate, and a revision was required to reflect the current regulatory situation and the needs of the sector.

 

The 2013 Code of GMP introduces a number of new measures as compared to the 2000 Code of GMP, including:

·                performing regular periodic quality review of all products to verify the consistency of processes and appropriateness of current specifications for both starting materials and finished products;

·                a requirement to have in place specific requirements for the handling of product returns from customers;

·                specific requirements for the maintenance of records relating to the freeze–drying and cryopreservation of products

 

The 2013 Code of GMP is available from the TGA’s website (www.tga.gov.au).

 

It is important to note that MP 1/2013 provides for a transitional period of 12 months from the commencement of MP 1/2013 (on 31 May 2013) for manufacturers of blood, blood components, biologicals or haematopoietic progenitor cells to comply with the 2013 Code of GMP.

 

Under the transitional arrangements (set out in subsection (14) of the instrument), it will not be mandatory for manufacturers of such goods to comply with the 2013 Code of GMP until 31 May 2014.

 

During the transition period between the commencement of MP 1/2013 and 31 May 2014, affected manufacturers will have the option of continuing to comply with the 2000 Code of GMP or to comply with the 2013 Code of GMP.

 

The transitional arrangements also make it clear that for manufacturers who opt to comply with the 2013 Code of GMP during the transition period, they must also ensure that they comply with applicable provisions of Therapeutic Goods Order 88 – Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood, blood components, human tissues and human cellular therapy products (TGO 88).

 

This requirement reflects that a number of requirements set out in the 2000 Code of GMP relating to the minimisation of infectious disease transmission were not replicated in the 2013 Code of GMP but have rather been set out (and amended) in TGO 88.

 

CONSULTATION

A draft of the 2013 Code of GMP was made available by the TGA for public consultation in December 2009.  A revised version, which took into account feedback received regarding the first draft, was published by the TGA in December 2010 for information.

 

In addition, in December 2010 the TGA undertook targeted consultation in relation to the 2013 Code of GMP and a draft of TGO 88 with several key industry organisations and sponsors to discuss the details of those proposed documents.  These bodies included the Australasian Tissue and Biotherapeutics Forum (ATBF), the Australian Red Cross Blood Service and CSL.

 

In addition, the 2013 Code of GMP has been considered and endorsed by the Therapeutic Goods Committee (the TGC) and by a subcommittee of the TGC dealing with biologicals.

 

Consultation was not undertaken specifically for 1/2013, as this was not considered necessary given that the main change introduced by the instrument, being the adoption of the new code was subject of extensive consultation as described above. The other measures that are included in MP 1/2013 are minor in machinery nature.

 

 

 

REGULATION IMPACT STATEMENT

The TGA prepared a (single) Regulation Impact Statement (RIS) in relation to both the Australian Code of GMP 2013 and TGO 88, and this was approved by the Office of Best Practice Regulation in January 2013 (OBPR ref 12594). A copy of the RIS is attached as Supporting Material.

 

In relation to compatibility with human rights, it is considered that this Determination is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is attached as Supporting Material.

 

SUPPORTING MATERIAL

1.         Regulation Impact Statement (RIS) for revision of manufacturing and technical standard requirements for human blood, human blood components, human tissues and human cell therapy products (2013); and

 

2.         Statement of compatibility for a legislative instrument that does not raise any human rights issues (Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013).