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GMP clearance for overseas manufacturers

Book pagination

16 May 2011

Introduction

These guidelines have been developed to provide information about the process of obtaining and maintaining Good Manufacturing Practice (GMP) clearances for the manufacturing steps of medicinal products including Active Pharmaceutical Ingredients (APIs) that are carried out overseas. They describe the approach of the Therapeutic Goods Administration (TGA) to granting GMP clearances in relation to these manufacturing steps and the documentation required for the assessment of applications.

The main objective of the Therapeutic Goods Act 1989 (the Act) is to ensure the safety, quality, efficacy and timely supply of therapeutic goods for Australian consumers. With the increasing number of overseas suppliers and the growing complexity in supply chains, Australian consumers are entitled to be confident that manufacturers located outside Australia are subject to equivalent quality standards of oversight to those applying to Australian manufacturers.

Therapeutic goods that are medicines (medicinal products) supplied in Australia are required to be included on the Australian Register of Therapeutic Goods (ARTG) by a process of registration or listing.1 The Office of Medicines Authorisation (OMA) in the TGA issues a marketing authorisation for a medicinal product when it is entered in the ARTG.

Under sections 25(1)(g) and 26A(3) of the Act a sponsor seeking registration or listing of a medicinal product must supply evidence that each overseas manufacturer involved in the manufacture of the product has acceptable manufacturing and quality control procedures in place.2 It is also a condition of ongoing registration and listing that such evidence is supplied on request.3

These rules apply if, had the goods been wholly manufactured in Australia, the Australian manufacturer would be required to hold a manufacturing licence under the Act.

The TGA considers whether the overseas manufacturer complies with the Manufacturing Principles (or equivalent international standards for overseas Manufacturers).4 This process and the issuing of a document that confirms compliance is known as GMP Clearance. For the purposes of undertaking GMP Clearance, the TGA considers an application by the sponsor and evidence from a number of sources.

The TGA has established a range of international agreements to facilitate the efficient and effective management of its regulatory compliance programs and reduce the regulatory burden on industry. They include:

  • Mutual Recognition Agreements (MRA) that are treaties between Australia and other countries and are enforceable under international law, and
  • Memoranda of Understanding (MOU) that are arrangements s between the TGA and regulatory agencies of other countries that facilitate the exchange of information.

The parties to an MRA recognise and accept the certification issued by the relevant regulatory agency in each country in relation to manufacturers located within that country.5

An overseas GMP Clearance can be granted by the TGA to a sponsor on the basis of GMP Compliance evidenced by any one of the following:

  • A GMP Certificate issued by a country with which Australia has an MRA in relation to the relevant overseas manufacturing site.
  • A Compliance Verification assessment of a recent GMP inspection report of the relevant overseas manufacturing site prepared by a competent overseas regulatory agency acceptable to the TGA, together with supporting manufacturing documentation supplied by the sponsor or manufacturer.
  • A GMP Certificate issued by the TGA following an on-site audit of the relevant overseas manufacturing site.

The TGA reserves the right to undertake an audit of an overseas manufacturing site, irrespective of any other evidence supplied. For example, this may be where TGA has other regulatory information, has concerns regarding compliance, or is auditing an adjacent facility. An audit may take place prior to granting an initial GMP Clearance for supply of the relevant product in Australia or at any time following the issue of a GMP Clearance.

Overseas GMP Clearances are granted for a specified time period. Sponsors must monitor the expiry date of GMP Clearances for all overseas manufacturers used and submit further applications with either supporting GMP evidence or a request for a TGA on-site audit of relevant overseas manufacturing sites before the current GMP Clearance expires.

As the TGA is required to recover the full cost of its regulatory activities, sponsors are required to pay to have an application for GMP Clearance assessed. Audit fees apply if the TGA carries out an overseas on-site audit.

The relevant fees and charges, including the basis of calculating fees, are located on the Schedule of fees and charges page.

TGA contact details

For further assistance, contact the TGA GMP Clearance Unit:
Tel: 1800 446 443
Fax: (02) 6232 8426
Email:
Post: GMP Clearance Unit
Office of Manufacturing Quality
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2600
To arrange for an audit of an overseas manufacturer, contact the TGA Licensing and Certification Unit.
Tel: 1800 446 443
Fax: (02) 6232 8426
Email:
Post: GMP Clearance Unit
Office of Manufacturing Quality
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2600

This information is also available on the Manufacturing therapeutic goods page.

Regulatory information

Information can be obtained from the Office of Medicines Authorisation about the circumstances in which a GMP Clearance is required for a particular activity involved in manufacturing a finished product or an API.

Sponsors can seek information or advice from an agent or regulatory consultant concerning the requirements for submitting an application for a clearance and/or the suitability and compliance of an overseas manufacturing site.

The TGA does not endorse agents or regulatory consultants. Further details concerning agents or consultants can be obtained from various industry associations or the Association of Therapeutic Goods Consultants Inc.

Links to these bodies are available on the Regulatory affairs consultants page.


Footnotes

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

2. The requirements in the Act vary, based on whether the final products are required to be registered or listed in the Register. For registered goods, section 25(1)(g) states:

25 Evaluation and registration of therapeutic goods

(1) ... the Secretary must evaluate the goods for registration having regard to:
...
(g) if a step in the manufacture of the goods has been carried out outside Australia - whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable;
...

For listed goods, section 26A(3) states:

26A Listing of certain medicines

3) Subject to subsection (7), if a step in the manufacture of the medicine has been carried out outside Australia, 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.

3. Conditions imposed under section 28 of the Therapeutic Goods Act sponsors are required to maintain evidence of GMP Compliance of an overseas manufacturer as a standard condition of registration or listing of a therapeutic good. Paragraph 23 of the Standard and Specific Conditions applying to Registered or Listed Therapeutic Goods determined under section 28(2) states:

23 Goods Manufactured Overseas

Where the registered/listed goods are imported goods which if manufactured in Australia would be required under the provisions of the Act to be manufactured in licensed premises, the sponsor of the goods 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.

4. On 1 July 2010, the TGA adopted the PIC/S Guide to GMP for Medicinal Products, January 2009 - PE 009-8, for both Medicinal Products and APIs. This standard replaces the Australian Code of Good Manufacturing Practice for Medicinal Products 16 August 2002, the ICH Q7 Guideline and the Code of Good Manufacturing Practice for Sunscreen Products.

5. The countries with which Australia has Mutual Recognition Agreements and the scope of the products covered by these agreements is included in Appendix B. The mutual recognition of certificates is limited to manufacturers within the country of the issuing authority. MRA Certificates for manufacturers outside the regulator’s country can be used as supporting evidence in conjunction with other documentary evidence as outlined in tables 1a and 1b.

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