Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook
Call Us Now:
+44 2080667260 sales@omcmedical.com

Australia Drug Registration Process

Home
Australia Drug Registration Process

Drug Registration Process in Australia

Ministry of Health

Department of Health and Aged Care

MoH website

https://www.health.gov.au/  

Regulatory Authority

Therapeutic Goods Administration (TGA)

Link for Regulatory Authority

https://www.tga.gov.au/

Regulation

Therapeutic Goods Act 1989

Therapeutic Goods Regulations 1990

Website

https://ablis.business.gov.au/service/ag/australian-guidelines-for-the-registration-of-drugs/31302

Legislation

Australian legislation

Website

https://www.tga.gov.au/about-tga/legislation

Local Authorized Representative Required

Yes

FSC Required

Yes

License Validity

5 Years

Drug Classification

  1. Registered medicines
  2. All prescription medicines. (High Risk)
  3. Non-prescription medicines. (Low Risk)
  4. Listed medicines
  5. AUST L – Listed
  6. AUST L(A) – Assessed Listed

Overview

One of the developing markets for pharmaceuticals is Australia. Therapeutic Goods Administration (TGA) regulate medicines, medical devices and biologicals to help Australians stay healthy and safe. Manufacturers are required to get clearance from the TGA, which regulates medication registration and approval in Australia, before distributing or selling medicinal items or pharmaceuticals. 

For the registration and maintenance of goods, compliance, and drug approval procedure for medical products in Australia, the TGA has certain regulatory criteria. Manufacturers or sponsors must stay up to speed with the most recent TGA Regulatory regime owing to recent demands regarding labeling and submission forms.

TGA Regulation of Medicines

  • All medications delivered within Australia are required to be registered in the Australian Therapeutic Goods Register (ARTG).
  • Drugs will appear in the ARTG either Listed or Registered. The AUST L, AUST L(A), or AUST R number (which is the medication’s ARTG number) on the label indicates whether a medication is listed or registered.
  • Before going on sale, registered medications are always assessed for effectiveness, or the ability to perform as promised. However, not every medication on the list had its efficacy assessed.
  • Two categories of listed medications exist:
  1.   ‘listed’ AUST L medications that have not had their effectiveness evaluated.
  2.  Medications on the AUST L(A) “assessed listed,” whose efficacy in relation to health claims has been evaluated.
  • A medication must be produced in a licensed or approved facility in compliance with the good manufacturing practice (GMP) guidelines, regardless of whether it is registered or listed in the ARTG.

Differences between listed, assessed listed and registered medicines

Qualities/attributes

Listed

Assessed listed

Registered

ARTG/AUST No.

AUST L

AUST L(A)

AUST R

Pre-market efficacy assessment

no

Yes

Yes

Ingredients

Only from a list of pre-approved ingredients.

Only from a list of pre-approved ingredients.

Ingredients are assessed pre-market

Indications (conditions the medicine says it will treat)

Only from a list of pre-approved conditions.

 

Conditions are assessed pre-market

Conditions are assessed pre-market

Subject to post-market compliance reviews

Yes

Yes

No

Subject to post market surveillance (e.g. adverse event monitoring)

Yes

Yes

Yes

Available off-the-shelf

Yes

Yes

Some

Need for a prescription from a health professional

No

No

Some

Able to use ‘TGA assessed’ claim

No

Yes

Yes, for registered complementary medicines

Registered Medicines

  • Medicines that are registered have a greater risk. As a result, before any licensed medication is put on the market, it is thoroughly evaluated for quality, safety, and efficacy. Before the medication is put on the market, we also approve its label. TGA keeps an eye on the medication to make sure it stays safe when it is made available. We have the right to revoke or suspend the medication’s registration if any problems are discovered.
  • The kind of drug determines how it is sold once it has been registered. The majority of legally approved over the counter and supplementary medications are sold off the shelf. On the other hand, some licensed OTC medications may only be obtained after a consultation with a pharmacist, and prescription medications can only be obtained with a legitimate prescription from a medical provider.

Listed medicines

  • The listed medicines are less dangerous and are available off the shelf at pharmacies, health stores, and supermarkets.
  • TGA does not evaluate the efficacy of every listed medication before it is put on the market, in contrast to registered medications. Additionally, we don’t give the medicine’s label our approval before it is sold. This is because our regulatory framework is risk-based, meaning that medications with higher potential risks are subject to stricter regulations than those with lower potential risks. Sponsors must, however, attest that the medication conforms with all applicable regulations and that they have proof that the medication performs as promised.
  • TGA only permits listed medicines to have pre-approved low risk components and make low level health claims because these medications do not undergo any pre-market review. A listed medication, for instance, may make the low-risk claim that it “relieves throat irritation,” but not the high-risk claims that it “cures rheumatoid arthritis” or “reduces high blood pressure.”
  • A listed medication may be chosen for a post-market review in which the sponsor will be asked to submit documentation of regulatory compliance. This covers labeling and the evaluation of efficacy evidence. Should we discover that the medication does not meet all relevant regulatory standards, the medication’s listing might be halted or terminated.

Assessed listed medicines

  • Compared to other listed drugs, assessed listed medicines make somewhat riskier health claims. An ailment such as rheumatoid arthritis or tinnitus, for instance, may not be mentioned by a listed drug; but an evaluated listed medicine could be able to. Before being put on sale, the effectiveness of these medications is evaluated. Assessed listed medications may utilize a ‘TGA assessed’ claim (this might be a statement or symbol) on the pharmaceutical label since their efficacy has been evaluated before marketing.
  • It is possible for registered supplementary medicines to make advantage of the ‘TGA evaluated’ claim. Other registered medications do not exhibit the ‘TGA evaluated’ claim.

Dossier Requirements

Section 23 of the Act is where category 1 and 2 applications for new registrations are made. Applications must be submitted in a format that has been authorized by the Secretary, under Section 23. The CTD format is the one that is currently authorized. Section 9D of the Act governs category 1 and category 2 requests to change a registered therapeutic good’s inclusion in the Australian Register of Therapeutic Goods (ARTG). Applications must be submitted in a way that has been authorized by the Secretary, under Section 9D. The CTD format is presently the accepted method.

The CTD format is described in the following documents:

Category 1 and 2 applications, except the applications related to additional Trade name, must comply with the following regulatory documents:

or

Apart from the documentation mandated under the section 9D and section 23 instruments, the TGA has generated other materials that offer extra support to applicants filing a Pre-submission Planning Form (PPF) or dossier. Among them are:

eCTD is recommended for all prescription medicine applications and can also be used for:

  • biologicals
  • over-the counter medicines
  • registered complementary medicines
  • assessed listed medicines
  • ingredients for listed medicines
  • master files.

Registration Phases

  1. Pre-submission

The Pre-submission stage begins upon filing the Pre-submission Planning Form (PPF) and ends when the applicant receives a Planning Letter from TGA. Applications in categories I and II must follow this stage. The Pre-Submission Planning Form (PPF) is where the applicant should provide planning data to TGA. It contains facts regarding the intended application type, its scope and size, and the quality, nonclinical, and clinical evidence that will be included in the dossier. The TGA recommends attaching a full copy of CTD Module 2. Every PPF received on the first of the month is processed by TGA. It confirms that every form is accurate and full once the PPF is submitted. After that, a Planning Letter will be sent to the applicant.

Planning letter includes the deadline for the applicant to submit the dossier and the anticipated dates for the regulatory process’ checkpoints. It also lists any problems the TGA found after reviewing the application. The planning letter is sent to the applicant by the fifteenth day of the month after the TGA processes the PPF.

  1. Submission Phase (1.5 months)

Processing tasks are completed during the submission step to prepare the application for review. Among the processing tasks for the TGA are:

  1. Verification that the dossier will arrive by the scheduled filing date.
  2. confirmation that the application fee has been paid.
  3. Planning workflows and managing IT.
  4. evaluation of the application under the TGA Regulations.
  5. sending out a notification letter with the notice of evaluation fee payment (if applicable).

3.  First Round Assessment Phase (3-4 months)

The day following the applicant’s notification letter delivery is when the first-round assessment procedure will start. Every piece of information included in the dossiers is examined and assessed by the TGA examiners. The timeframe for first round assessment is 3 months for New Generic medicine applications & 4 months for other applications. Following data examination, TGA complies, verifies, and approves a consolidated section 31 request for information or documents if there are any concerns or queries about the application.

A letter including a combined section 31 request for information or documents OR a copy of the first-round assessment reports created by the quality, nonclinical, clinical, and RMP is sent by the authority to the applicant.

  1. Consolidated Section 31 Request Response Phase (2-3 months)

It gives the applicant enough time to think about TGA’s combined section 31 request for documents or information, draft a response, and send it to TGA.

If the applicant does not reply within the designated timeframe, the TGA information will be used to finish the second-round evaluation.

  1. Second round assessment Phase (1-2 months)

During the second-round assessment, the data provided by the applicant in response to the section 31 request is evaluated. TGA publishes the evaluation report for the second round of assessments following the assessment, within two months for new applications for generic drugs and within a month for all other applicants.

TGA notifies the applicant through the assessment report whether-

  • The application is sent to the advisory committee by the TGA. Before the meeting, applicants will have 13 working days to evaluate the Evaluation report and let TGA know if there are any apparent factual errors or omissions.
  • The application is not referred to the advisory committee by the TGA. Following that, applicants will have 14 calendar days to examine the Evaluation report and let TGA know about any inaccuracies or omissions they believe to be true.

  1. Expert Advisory Review Phase (2 to 3 months)

The most important advisory body for prescription drugs is the Advisory Committee on Medicine (ACM). The committee has the option to consult with outside, impartial specialists.

This process begins when the applicant receives information via the evaluation report to refer to the advisory committee, and it concludes when the committee provides the applicant with the necessary advice.

The advice from the ACM meeting minutes is recorded and given to the applicant and delegates at the next meeting, which is slated to take place ten working days following the ACM meeting.

  1. Decision Phase (1.5 months)

The TGA delegates decide whether to accept (maybe with modifications or changes) or deny the application. Before making a final decision about the registration of the pharmaceutical goods in Australia, the delegate communicates directly with the applicant at this phase if there are any unresolved problems that impact the decision.

  1. Post Decision Phase

The process starts when the TGA notifies the applicant of its decision and concludes when the delegate makes it.

  • Only once the applicant submits a patent certificate or notification can a new ARTG (Australian Register of Therapeutic Goods) registration be made.
  • TGA will verify that the authorized product description matches the tentative ARTG record.
  • The ARTG Record of Registration will replace the temporary ARTG record.
  • The applicant must also complete all other conditions specified in the decision letter and notify the TGA of the actual date of marketing initiation.
  • The TGA website should be used to disseminate the decision and the product’s medical information.

Fees

Application Type

Application Fee

Evaluation Fee

New Chemical Entity

$54,292

$217,598

New Generic Product

$20,939

$83,110

OTC New Medicines Registration Process

Over the counter (OTC) medicines are sold without a doctor’s prescription and have undergone a full TGA pre-market evaluation of their safety, quality, and efficacy before being supplied in the marketplace. OTC medicines are mostly like prescription medicines as they contain higher-risk ingredients and make higher-risk indications than certified/ registered complementary medicines.

Registration Phases

Step 1 – Verifying your OTC medicine and access to Business Services

  • For the verification of an OTC medicine that requires registration on the ARTG, refer guidance: Pathway to evaluating your medicine
  • Applications are created and lodged through the Business services.  A client ID number and password will be required to access the business services.
  • Proceed to Step 2 in case a previous determination has been made that the medication is an over the counter (OTC) product requiring registration on the ARTG, and possession of a client ID number and password for accessing TGA Business services.

Step 2 – Checking for new medicine ingredients:

Before applying for OTC medicine, an assessment should be done for new ingredients. The ingredient should be checked from:

  • Ingredients Table
  • Proprietary Ingredients Table

Step 3 – Determining Application Level:

Applications to register an OTC medicine are categorized into five levels, based on risk and have different fees and target evaluation times.

  1. N1 Generic medicines that meet the requirements for OTC new medicine N1 applications (clones or flavour/fragrance/colour variants of a currently registered medicine).
  2. N2 Generic medicines that fully meet a specific OTC monograph and the general requirements for OTC New Medicine N2 applications.
  3. N3 Generic medicines that are not an N1, N2 or N4 level application (N3 applications require CTD Modules 1 and 3).
  4. N4 Generic medicines that require supporting safety and/or efficacy data / have not been previously registered as an OTC medicine following down/ scheduling require a higher-level assessment due to the umbrella segment of the product name.
  5. N5 New medicines that are not generic, including either one or more new: active ingredient (new chemical entity), combination of active ingredients, indication, strength, dosage form, directions for use for patient population.

Step 4 – Checking guidelines and mandatory requirements

All the relevant guidelines for specific requirements should be checked

  1. OTC -specific guidelines
  2. European Union and ICH guidelines adopted in Australia

The following mandatory requirement should be followed for an effective and successful application.

  1. Mandatory requirements for an effective OTC medicine application
  2. CTD Module 1: OTC medicines Take note of the obligation stated in CTD Module 1.5.8, which necessitates the submission of an umbrella brand assessment for applications requiring a more extensive evaluation because of the umbrella segment in the product name.
  3. Common Technical Documentation (CTD)
  4. General dossier requirements
  5. Cover letter

Step 5 – Ensuring valid GMP evidence

  • Valid evidence that the manufacturers of your OTC registrable medicines have been certified to perform each step in the manufacture of the goods is necessary.
  • Failure to provide valid evidence of GMP will result in failure to validate the application upon submission.
  • The application cannot be concluded unless there is up-to-date and valid GMP clearance (issued by the TGA) for every foreign manufacturer. It is imperative to guarantee that the GMP clearance remains valid throughout the evaluation period.
  • Ensure that the GMP clearance remains valid for at least the specified minimum duration following the submission of application.

 3 months: N1 applications

4 months: N2 applications

6 months: N3, N4, and N5 applications.

Step 6 – Compiling data for application

1. A dossier of administrative and technical documentation for OTC medicine must be submitted in electronic format for evaluation.

2. Compile an electronic dossier in accordance with the Common Technical Documentation (CTD). Make certain that the application dossier comprises all necessary administrative and technical data essential for the application level.

3. Verify that the dossier is complete, follows the specified format, and incorporates the necessary details for a comprehensive application outlined in CTD Module 1 for OTC medicines.

4. This should cover the mandatory requirements for an effective OTC medicine application and adhere to the guidance provided for composing your cover letter.

Step 7 – Completing and submitting your application

To complete and submit your application, following steps to be followed:

  1. Log in to Business services.
  2. Select ‘Applications’.
  3. Select the appropriate application form under Over-the-Counter Medicine.
  4. Complete the application form.
  5. Attach the application dossier (compiled in Step 6) to the application form or submit the dossier on CD/DVD/USB.
  6. Select ‘Submit’ and agree to the declaration and relevant assurances.

   A submission number will be issued which uniquely identifies the application.

Step 8 – Paying fees

TGA charges an application fee and an evaluation fee based on the level of the application.

Application type

Application fee

Evaluation fees

N1 application

$1,835

$4,533

N1 concurrent application per additional application

$928

$4,533

N2 application

$1,835

$6,444

N2 concurrent application per additional application

$928

$6,444

N3 application

$2,947

$9,930

N3 concurrent application per additional application

$1,479

$5,030

N4 application

$4,307

$16,514

N4 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations)

$1,479

$5,030

N5 application

$6,379

$24,285

N5 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations)

$1,479

$5,030

Applicant can apply for concurrent (reduced) costs, if there are multiple applications submitted at the same time, provided all the applications have:

  • same sponsor;
  • same application level.
  • the same active components.
  • enough similar supporting data to allow for simultaneous review.

Step 9 – Screening of application

1. Screening of OTC medicine applications will be done to verify if it has been submitted at the correct application level and meets the effective requirements.

2. Application is effective if it meets the requirements mentioned under section 23(2) of the Therapeutic Goods Act 1989.

Step 10 – Evaluating and requesting information

During evaluation of OTC medicine application, TGA will:

–        assess the data and information,

–        review your responses to our requests for information and document the findings.

Step 11 – Making the OTC registration decision

The delegate of the Secretary of the Department of Health will:

1. Review all documentation associated with the application, including:

2. The application and submission dossier

3. The evaluation reports

4. Responses to requests for information

5. Advice from expert advisory committees

6. Other relevant advice or information

7. Consider the detailed matter under section 25 of the Act, including whether the medicine’s effectiveness, safety, and quality have been demonstrated.

8. Once the decision is made, TGA will send out a written notification of the decision.

Step 12 – Finalizing your OTC registration

1. This stage involves finalizing the registration once a decision has been made on whether to register an OTC medicine.

2. TGA provides the decision letter if it is decided to register the medication.

3. The decisions taken by the Secretary’s delegate to impose general and requirements on the registration of your medication in the register in accordance with Section 28 of the Therapeutic Goods Act 1989 are included in this letter.

Enquiry Now

    This will close in 0 seconds