Therapeutic Goods Administration (TGA) Australia published an updated document on the registration process for prescription medicine applications on the 12th of August 2021.
The scope of the document is for applications that need to be supported by non-clinical, clinical and/or bioequivalence data (category 1 and category 2).
The registration process is designed to improve the efficiency and timeliness of the registration of prescription medicines without compromising the scientific rigour of the evaluation process, thus ensuring the maintenance of appropriate standards of quality, safety, and efficacy.
Sections on expert advisory review phase were updated.
The updates include:
- Inclusion of the term “Advisory Committee on Vaccines (ACV)”, resulting in the use of the phrase “Advisory Committee on Medicines (ACM)/ACV”, rather than only ACM
- Additional details regarding the Pre-ACM/ACV responses (within 5.6.4.2)
- Updated timeframes for provision of ACM/ACV minutes in line with current practice (within 5.6.3 & 5.6.4.4)
Key dates for expert advisory review phase
The expert advisory review phase commences on the day the delegate’s Request for ACM/ACV advice (also referred to as the Delegate’s Overview for ACM/ACV) is sent to the applicant. This date is at least 23 working days prior to the proposed ACM/ACV meeting.
The Pre-ACM/ACV response from the applicant must be is received by the committee secretariat at least 13 working days before the meeting date. This is to ensure that ACM/ACV have adequate time to consider the information.
The expert advisory review phase ends when the ACM/ACV advice is sent to the applicant. This generally occurs on the Friday two weeks after the meeting (10 working days after the ACM meeting or 12 working days after the ACV meeting).
Outcome of the ACM/ACV meeting
The ACM/ACV advice is documented in the ACM/ACV ‘minutes’ document, which is provided to the delegate and applicant following the meeting. This generally occurs on the Friday two weeks after the meeting (10 working days after the ACM meeting or 12 working days after the ACV meeting).
- Removal of the Pharmaceutical subcommittee information
- Expectation for reviewing evaluation reports combined for both applications that attend ACM/ACV and that do not attend ACM/ACV (within 5.7.4.1)
Applicants will be given a period of 14 calendar days after the TGA issues the final evaluation report(s) in which to review and advise the TGA of any perceived errors of fact or major omissions.
- Inclusion of information about Decision Summaries (within 5.8.5)
The Australian Prescription Medicine Decision Summary provides a short overview of the TGA’s evaluation process leading to the registration of a new prescription medicine on the ARTG. Australian Prescription Medicine Decision Summaries are drafted during the post-decision phase and published on the TGA website .
More details can be found in “Prescription medicines registration process”, version 2.5, August 2021: https://www.tga.gov.au/prescription-medicines-registration-process