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GMP clearance process for MRA countries

17 March 2016

We receive a large number of Good Manufacturing Practice (GMP) Clearance applications which use a GMP Certificate issued by a Mutual Recognition Agreement (MRA) partner for a manufacturing site located in the same country (MRA GMP Clearance applications).

The Australian Regulatory Guidelines Good Manufacturing Practice (GMP) Clearance for Overseas Manufacturers 17th Edition (GMP Clearance Guideline) specifies that Australian sponsors of medicines manufactured overseas have a responsibility to ensure that all required documents are submitted with a GMP Clearance application or this may result in the clearance not being issued.

We estimate that about 10% of MRA GMP Clearance applications we receive do not provide us with sufficient supporting evidence to demonstrate that the manufacturing site is acceptable for supplying product to the Australian market. We have been making efforts to contact the applicants to provide this information. However, with the number of applications we are receiving (approximately 2000 MRA applications per year) this is impacting our overall processing timelines. To ensure that applicants who provide all required information are not disadvantaged, we will cease this practice and make decisions on MRA GMP Clearance applications based on the information provided with the application.

To assist applicants in preparing their applications, we provide the following advice about supporting evidence for MRA GMP clearance applications you need to give us so we can determine whether we can issue a GMP Clearance:

  • A GMP Certificate for an Active Pharmaceutical Ingredient (API)/Finished Product Manufacturer, a Good Laboratory Practice (GLP) Certificate for testing laboratories or Certification to relevant International Organization for Standards (ISO) for sterilisation facilities, must be provided as supporting evidence.
  • The GMP Certificate provided as supporting evidence must be current. This means that the application must be submitted before the expiry date shown on the GMP Certificate, or the date of inspection must be less than three years ago, if there is no expiry date on the GMP Certificate. Recognising that the inspection conducted by the other regulator may not always be completed before the expiry date, or within three years from the last inspection, we will accept:
    • A GMP Certificate that has expired less than six months after the expiry date shown on the GMP Certificate, or
    • If there is no expiry date, we will accept a GMP Certificate where the inspection was carried out less than three and half years ago.
  • The manufacturing site address in your GMP Clearance application must match that on the GMP Certificate you provide as supporting evidence.
  • For manufacturing sites that make APIs, a Manufacturer's Declaration is needed where the APIs being manufactured are not included in the GMP Certificate provided with the application, but they are manufactured using a similar manufacturing process, under the same quality system.
  • If an applicant wishes to access another sponsor's GMP Clearance or evidence you must supply a Letter of Access.
  • The scope of manufacturing steps in your GMP Clearance application must match that shown on the GMP Certificate you provide as supporting evidence. This is an area where we routinely find that mistakes are made. To assist applicants, some common examples include:
    • Where the application is for a finished product, but the GMP Certificate provided as supporting evidence only covers the manufacture of APIs.
    • Where the application is for a sterile product, but the GMP Certificate provided as supporting evidence only covers the manufacture of a non-sterile product.

Please note: that if you are unable to obtain a GMP certificate issued by the MRA country for a site within that country, you are able to request that the TGA attempt to obtain the evidence from the MRA regulator (at an additional fee) by selecting the checkbox for liaison in your application.

Please also note: that the information provided here does not replace the requirements specified in the GMP Clearance Guideline (see above) and we strongly recommend that before submitting your application you assure yourself that your application meets all applicable requirements.