The Therapeutic Goods Administration (TGA) has recently modified the registration process for prescription medicines and biologicals. The changes are applicable to new medicines, extended uses, and new combinations. Once approved, the drugs enter into the Australian Register of Therapeutic Goods (ARTG) and are available to people upon prescription by physicians.
Revised in August 2021, the new document describes how the prescription medicine applications need to be supported by non-clinical, clinical, and/or bioequivalence data (category one (01) and category two (02)). The renewed process helps reduce the timelines and enhance the efficacy of the registration method. At the same time, it upholds the scientific precision of the evaluation process, thus adhering to the specific standards of safety, efficacy, and quality.
Several modifications to the previous method and understanding the revised process can help the applicants in their endeavor.
Major revisions as per the new Registration process
Management by Milestones
Per the latest document by TGA, the registration process is spread over eight (08) phases with eight (08) milestones. There are defined timelines for each of them. The new Regulatory method allows for ‘batch processing’ of registrations. This facilitates a group of applications to be evaluated simultaneously, thus saving time and money (fee).
Quality of Applications
TGA is taking all steps to ensure the quality of the applications. These need to be compliant, best quality and designed as per the Regulatory requirements. If any criteria are not met in the prescription drugs’ registration process described by the TGA, the application is termed as ‘not effective.’ It is mandatory to submit the complete applications sans any errors.
Pre-submission Phase
The applicants have to submit the Pre-submission Planning Form (PPF) to the TGA at this phase. Details such as the type of the application, quality of the medicine, and the clinical and non-clinical evidence are included in the Form. Once this is approved, a ‘Planning Letter’ is sent to the applicant with the pertinent timelines for the subsequent registration phases.
Submission Phase
At this stage, the applicants submit a dossier to the TGA. The dossier is evaluated for specific Regulatory requirements as per the Common Technical Document (CTD) format. Literature and format are checked thoroughly, and if they are non-compliant, the application is deemed ‘not effective’ and rejected. In this phase, the TGA makes no further requests for any missing information/details in applications, as per section 31 of the Therapeutic Goods Act of 1989.
Priority Review Designated Applications
This phase reduces the ‘time to market’ for life-saving prescription drugs. The complete data dossier is mandatory for the process. TGA has set a review period of one hundred and fifty (150) days for the said medicines in the Priority Review Regulatory pathway. Owing to the benefits of these prescription drugs to patients, the registration timeframe has been shortened compared to the normal prescription medicines’ pathway.
Provisional Approval Pathway
The Provisional Approval method is a part of the renewed registration method. The relevant clinical data is considered in this phase. It applies to prescription medicines that are highly beneficial to treat specific medical conditions in patients. A valid Provisional determination is mandatory for this pathway.
The latest update by the TGA aims to help reduce the registration time taken for prescription drugs that are of significance to patients. The document contains details of the submissions that are to be made by the applicants at every milestone. For a compliant and timely registration, collaborate with a partner with an expert proficient with the latest norms. Stay updated! Be compliant!
