In Australia, medicines are included on the Australian Register of Therapeutic Goods (ARTG) as registered (AUST R) or Listed (AUST L) goods.

Registered products are further classified according to the level of risk and are evaluated by the TGA by the following categories:

Prescription medicine, OTC (over the counter), Complimentary Medicines and Listed Medicines.

Regulatory Concepts has a wealth of experience across many aspects of the registration process for each of these application categories, including eCTD publishing. Regulatory Concepts can guide you through the process and help you plan your submissions with the most practical solution to suit your budget.

Once registered we can assist with some of the basic requirements and provide important support to your PV team – find out more at Pharmacovigilance.

For all medicines, registered or listed, before any applications can be considered, acceptable GMP (Good Manufacturing Practice) Certification is required– find out more at GMP.

Presubmission

Prescription Medicines as well as other high-risk medicines are assessed by the TGA at the highest level. Both the active ingredients and the finished product are assessed. Both active ingredient and finished product manufacturers need to have acceptable GMP –We are able to provide you guidance on the options available to you to ensure you do not experience unnecessary delays.

We can assist you with the planning of your submission including setting up and managing a TGA Presubmission meeting. During the initial stages, if you are an overseas company without any representation in Australia, we can assist by acting as your surrogate sponsor until such time as you are ready to take over – find out more under Sponsorship.

Applications

Higher risk applications are referred to as category 1 applications and have the highest level of assessment fees applied. To make sure that your application has a chance of succeeding, Regulatory Concepts recommends doing a Gap Analysis on your proposed dossier. During a GAP analysis we check the details against the TGA mandatory requirements and determine if your dossier will pass or if updates are required. We can provide a summary of expected issues the TGA may raise so that the manufacturer can consider whether they can accommodate any probable changes the TGA might request.

eCTD Publishing

We have the capability to submit dossiers as published eCTD submissions, so can assist not only with new applications but also with old registrations where a baseline may be needed to bring an old dossier up to the new required standards- find out more at eCTD Publishing.

Maintenance

Maintenance activities we provide include, but are not limited to:-

  • updating GMP clearances.
  • updates to PI’s and CMI’s
  • safety updates for generic medicines (see PI’s & CMI’s)
  • updates to labels
  • variations for quality changes
  • updates to DMFs (drug master files) or CES (Certificates of Suitability) for active ingredients
  • lodgement of PSURS (refer to Pharmacovigilance)
  • submission for annual fee waivers (refer to Sponsorship)

New Zealand

If you have plans to enter the NZ market, we can assist with building those submissions and taking advantage of the Abridged registration pathway. As with Australian products, we can manage the maintenance requirements of your NZ registrations. We can help plan your labels so that you can use the same label in both Australia and NZ.

Applications

OTC medicine registration applications have many different levels. We can help review your planned submission and determine the best application level and prepare the submission accordingly. If your product is related to other products already on the market, we can assist with a comparison to ensure your product is presented at its most competitive level.

Advertising Clearance

Some claims may require advertising approval – Regulatory Concepts can help you with this process- see Labelling & Advertising

Rescheduling

Another aspect of OTC medicines is consideration of changing the existing schedule which a medicine might be in. You may wish to support an application to change the schedule of a medicine eg: from S4(prescription) to S3(Pharmacist Only) We can help assess the opportunity for a proposed rescheduling, review the planned documents to support a submission and put the submission together.

Maintenance

Maintenance activities we provide include, but are not limited to:-

  • Update of GMP clearances for Finished Product Manufacturer
  • Update of labels
  • Update of PIs and CMI’s
  • Variations for quality changes

Complementary Medicines can be either registered or listed.

Listed Medicines have two levels Assessed listings (AUST L(A)) or normal Listing (AUST L).

GMP

Before you can consider submitting any listing application you need to ensure your GMP for the manufacturer is acceptable. For overseas manufacturers this requires a GMP clearance from the TGA – find out more at GMP.

Applications

For normal listings, the choice of ingredients is restricted to a permitted list as are indication statements for both actives and non-actives.. Regulatory Concepts can review your product to determine if it will fit the profile of a normal listed medicine or suggest changes that may make the product eligible.

We can guide your manufacturer, with details of TGA preferred presentation of Finished Product Specifications, design of stability studies and other aspects of quality issues related to listed products.

New Substance Applications

If an ingredient is not on the list, we can assist you in planning and creating a submission for a new ingredient permission.

New Indications – Assessed Listing

If  a suitable indication that covers the way you wish to promote your product cannot be found, we can help plan and create a submission for an assessed listing. We can assess your evidence and determine if it is enough to support your planned submission to the TGA. We can also review your labels or prepare a draft label layout for you in accordance with the evidence and labelling rules.

Evidence Summaries

A normal listing application also needs to have evidence to support the claims being made. We can assist by reviewing or gathering the evidence and preparing the evidence summaries according to the TGA required templates – find out more at Evidence for Listing.

Maintenance

Maintenance activities we provide include, but are not limited to:-

  • Update of GMP clearances
  • Revision of labels due to changes in TGA guidelines
  • Updates of listing applications due to changes in ingredient requirements
  • Updates of listing applications due to inclusion of new claims or revised artwork

Registered Complimentary Medicines(CM)

We can plan the development of data to be generated to support a CM registration, write up the dossier according to eCTD format and submit it as a published eCTD. We can also design labels according to the guidelines and ensure that the indication statements made on the label do not require advertising clearance. If a specific claim requires advertising clearance we can assist to ensure the appropriate documentation is gathered to support an advertising clearance application.

New Zealand

New Zealand does not have a category that is equivalent to the Australian Listing category, however we can assist in finding the best pathway to introduce your product into NZ according to your resources.

Pharmacovigilance (PV) is a minefield of regulations and requirements. Regulatory Concepts can assist by supporting your PV department.

eCTD Publishing

As we have the capability to publish eCTD dossiers, we can prepare the eCTD submission required for annual PSUR submissions or a safety related update to a PI if a safety alert has been notified.

Safety Related Updates

Generic medicines have a specific requirement of ensuring PI’s are always up to date with the Innovator PI, especially if there have been any safety updates – we can assist in monitoring innovator PI’s for changes and then assessing if any updates are required and follow through with the required submission and update of your PI and CMI as applicable – refer to PIs & CMIs.

Reporting ADR’s(Adverse drug reactions) to TGA

If reporting of an ADR is required, we can assist by completing the online reporting form and following through the process of communication with the TGA. We can assist in maintenance of your ADR reports.

Risk Management Report

If your prescription medicine submission requires a PV risk assessment report, we can assist in creating the Australia Specific Annex which is required for such a submission.

Prescription Medicines

Presubmission

Prescription Medicines as well as other high-risk medicines are assessed by the TGA at the highest level. Both the active ingredients and the finished product are assessed. Both active ingredient and finished product manufacturers need to have acceptable GMP –We are able to provide you guidance on the options available to you to ensure you do not experience unnecessary delays.

We can assist you with the planning of your submission including setting up and managing a TGA Presubmission meeting. During the initial stages, if you are an overseas company without any representation in Australia, we can assist by acting as your surrogate sponsor until such time as you are ready to take over – find out more under Sponsorship.

Applications

Higher risk applications are referred to as category 1 applications and have the highest level of assessment fees applied. To make sure that your application has a chance of succeeding, Regulatory Concepts recommends doing a Gap Analysis on your proposed dossier. During a GAP analysis we check the details against the TGA mandatory requirements and determine if your dossier will pass or if updates are required. We can provide a summary of expected issues the TGA may raise so that the manufacturer can consider whether they can accommodate any probable changes the TGA might request.

eCTD Publishing

We have the capability to submit dossiers as published eCTD submissions, so can assist not only with new applications but also with old registrations where a baseline may be needed to bring an old dossier up to the new required standards- find out more at eCTD Publishing.

Maintenance

Maintenance activities we provide include, but are not limited to:-

  • updating GMP clearances.
  • updates to PI’s and CMI’s
  • safety updates for generic medicines (see PI’s & CMI’s)
  • updates to labels
  • variations for quality changes
  • updates to DMFs (drug master files) or CES (Certificates of Suitability) for active ingredients
  • lodgement of PSURS (refer to Pharmacovigilance)
  • submission for annual fee waivers (refer to Sponsorship)

New Zealand

If you have plans to enter the NZ market, we can assist with building those submissions and taking advantage of the Abridged registration pathway. As with Australian products, we can manage the maintenance requirements of your NZ registrations. We can help plan your labels so that you can use the same label in both Australia and NZ.

OTC Medicines

Applications

OTC medicine registration applications have many different levels. We can help review your planned submission and determine the best application level and prepare the submission accordingly. If your product is related to other products already on the market, we can assist with a comparison to ensure your product is presented at its most competitive level.

Advertising Clearance

Some claims may require advertising approval – Regulatory Concepts can help you with this process- see Labelling & Advertising

Rescheduling

Another aspect of OTC medicines is consideration of changing the existing schedule which a medicine might be in. You may wish to support an application to change the schedule of a medicine eg: from S4(prescription) to S3(Pharmacist Only) We can help assess the opportunity for a proposed rescheduling, review the planned documents to support a submission and put the submission together.

Maintenance

Maintenance activities we provide include, but are not limited to:-

  • Update of GMP clearances for Finished Product Manufacturer
  • Update of labels
  • Update of PIs and CMI’s
  • Variations for quality changes
Complementary (Listed) Medicines

Complementary Medicines can be either registered or listed.

Listed Medicines have two levels Assessed listings (AUST L(A)) or normal Listing (AUST L).

GMP

Before you can consider submitting any listing application you need to ensure your GMP for the manufacturer is acceptable. For overseas manufacturers this requires a GMP clearance from the TGA – find out more at GMP.

Applications

For normal listings, the choice of ingredients is restricted to a permitted list as are indication statements for both actives and non-actives.. Regulatory Concepts can review your product to determine if it will fit the profile of a normal listed medicine or suggest changes that may make the product eligible.

We can guide your manufacturer, with details of TGA preferred presentation of Finished Product Specifications, design of stability studies and other aspects of quality issues related to listed products.

New Substance Applications

If an ingredient is not on the list, we can assist you in planning and creating a submission for a new ingredient permission.

New Indications – Assessed Listing

If  a suitable indication that covers the way you wish to promote your product cannot be found, we can help plan and create a submission for an assessed listing. We can assess your evidence and determine if it is enough to support your planned submission to the TGA. We can also review your labels or prepare a draft label layout for you in accordance with the evidence and labelling rules.

Evidence Summaries

A normal listing application also needs to have evidence to support the claims being made. We can assist by reviewing or gathering the evidence and preparing the evidence summaries according to the TGA required templates – find out more at Evidence for Listing.

Maintenance

Maintenance activities we provide include, but are not limited to:-

  • Update of GMP clearances
  • Revision of labels due to changes in TGA guidelines
  • Updates of listing applications due to changes in ingredient requirements
  • Updates of listing applications due to inclusion of new claims or revised artwork

Registered Complimentary Medicines(CM)

We can plan the development of data to be generated to support a CM registration, write up the dossier according to eCTD format and submit it as a published eCTD. We can also design labels according to the guidelines and ensure that the indication statements made on the label do not require advertising clearance. If a specific claim requires advertising clearance we can assist to ensure the appropriate documentation is gathered to support an advertising clearance application.

New Zealand

New Zealand does not have a category that is equivalent to the Australian Listing category, however we can assist in finding the best pathway to introduce your product into NZ according to your resources.

Pharmacovigilance

Pharmacovigilance (PV) is a minefield of regulations and requirements. Regulatory Concepts can assist by supporting your PV department.

eCTD Publishing

As we have the capability to publish eCTD dossiers, we can prepare the eCTD submission required for annual PSUR submissions or a safety related update to a PI if a safety alert has been notified.

Safety Related Updates

Generic medicines have a specific requirement of ensuring PI’s are always up to date with the Innovator PI, especially if there have been any safety updates – we can assist in monitoring innovator PI’s for changes and then assessing if any updates are required and follow through with the required submission and update of your PI and CMI as applicable – refer to PIs & CMIs.

Reporting ADR’s(Adverse drug reactions) to TGA

If reporting of an ADR is required, we can assist by completing the online reporting form and following through the process of communication with the TGA. We can assist in maintenance of your ADR reports.

Risk Management Report

If your prescription medicine submission requires a PV risk assessment report, we can assist in creating the Australia Specific Annex which is required for such a submission.

Regulatory Concepts

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