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Draft Australian regulatory guidelines for GMP clearance for overseas manufacturers


30 September 2010

This consultation closed on 15 November 2010.

The TGA invited sponsors and manufacturers to comment on a revision of the guidance document provided by the TGA for the assessment of GMP compliance for overseas manufacturing sites.

It is proposed to update the document Guidance on the GMP clearance of overseas medicine manufacturers, 16th Edition, March 2008 to improve its readability guide and streamline the evidence requirements.

Consultation document

How to access a pdf document

Draft Australian regulatory guidelines for GMP clearance for overseas manufacturers (pdf,197kb)


Sponsors seeking the registration or listing of a therapeutic good the manufacture of which involves a step carried out outside of Australia must provide evidence that the site has satisfactory manufacturing and quality control procedures.

The TGA has established a GMP Clearance program under which controls in place at these manufacturing sites outside Australia are assessed against equivalent manufacturing standards that apply to Australian manufacturers. The clearance is given on the basis of the provision by the sponsor of one of following:

  • a certificate issued by a country with which the TGA has a Mutual Recognition Agreement;
  • a certificate issued by a recognised overseas regulatory authority following an on-site inspection of the overseas manufacturing site, together with a site master file and procedures supplied by the manufacturer (a compliance verification or 'desktop' assessment); or
  • a certificate issued by the TGA following an on-site inspection of the overseas manufacturing site.

The TGA established a working group with representatives nominated by the medicines industry associations in early 2009 for the purpose of reviewing the 2008 guidance document. The working party has reviewed several versions of a revised document. The revised document was also circulated for comment to the following industry associations:

  • Medicines Australia
  • Generic Medicines Industry Association
  • Australian Self Medication Industry Association
  • Complementary Healthcare Council
  • Advocate for the Consumer, Cosmetic, Hygiene and Speciality Products Industry (ACCORD)

Industry associations requested the draft of the revised guide to be made available on TGA's website for comment by manufacturers and sponsors prior to its adoption.

Legislative basis

Therapeutic goods supplied in Australia are required to be listed or registered on the Australian Register of Therapeutic Goods (ARTG)1.

The sponsor of a medicine that is a registered or listed therapeutic good where one step in the manufacture of the goods has been carried out overseas is required to supply evidence that each overseas manufacturer involved has satisfactory manufacturing and quality controls in place.

Where such a medicine is being considered for registration, section 25(1)(g) of the Act requires the Secretary to evaluate it having regard to

" ... whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable;"

Where an application has been made for listing of such a medicine, section 26A(3) of the Act requires that:

" ... the Secretary must have certified, prior to the application being made, that the manufacturing and quality control procedures used in each such step are acceptable."

It is also a condition of registration and listing under section 28 of the Act that the sponsor maintain evidence of the standard of manufacture where goods are manufactured overseas. The sponsor of imported registered or listed goods which, if manufactured in Australia would be required to be manufactured in licensed premises, is subject to the condition in paragraph 23 of the current Standard and Specific Conditions. This condition states that such a sponsor:

" ... shall, upon request at any time by the Secretary or the Secretary's delegate appointed for the purposes of section 31 of the Act, provide to the National Manager, Therapeutic Goods Administration, an acceptable form of evidence which establishes the standard of manufacture of the goods. If this is not available, the sponsor shall pay the costs of an inspection of the principal Manufacturer of the goods by Australian inspectors where this is considered necessary by the Secretary or the Secretary's delegate referred to in this paragraph."

1Under the Therapeutic Goods Act 1989 some therapeutic goods are not required to be included on the ARTG.

Proposed guidelines

The draft Australian Regulatory Guidelines for GMP Clearance for Overseas Manufacturers sets out revised requirements for obtaining and maintaining Good Manufacturing Practice (GMP) Clearances for overseas manufacturing steps for registered and listed medicines, including APIs (Active Pharmaceutical Ingredients) produced overseas.

The main changes to the current guidance are as follows:

  • clarification of assessment requirements and processes for getting GMP clearance for overseas manufacturing sites;
  • the addition of a list of sponsor responsibilities in obtaining and maintaining those clearances;
  • amended evidential requirements to address difficulties experienced by sponsors in obtaining particular documents from regulators and manufacturers (including delays in the release of inspection reports);
  • a description of the criteria used for granting Clearance approval and determining its duration;
  • the addition of TGA performance timeframes for the assessment of applications;
  • new provisions describing the circumstances in which an application will be rejected or lapse; and
  • the addition of procedures for the review of GMP clearance assessments.

Notes on submissions

A list of parties making submissions, and all submissions received, will be published on the TGA's website.

However, if you propose to include confidential material, it should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included.

For submissions made by individuals, all personal or identifying details, other than the name, will be removed from the submission being published on the TGA's website. If you do not wish to have your name included, you must specifically request this.