Aklief
Registration timeline
The following table summarises the key steps and dates for this comparable overseas regulator approach B (COR-B) application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 30 April 2020 |
| First round evaluation completed | 28 August 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 21 September 2020 |
| Second round evaluation completed | 15 October 2020 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 3 November 2020 |
| Sponsor's pre-Advisory Committee response | 12 November 2020 |
| Advisory Committee meeting | 4 December 2020 |
| Registration decision (Outcome) | 11 January 2021 |
| Completion of administrative activities and registration on ARTG | 18 January 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 166 |
*Statutory timeframe for standard applications is 255 working days
Apply a thin layer of Aklief cream to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin.
It is recommended that the physician assesses the continued improvement of the patient after three months of treatment. The duration of treatment should be determined by the doctor based on the clinical response.
For further information refer to the Product Information.
Aklief (trifarotene) was approved for the following therapeutic use:
Aklief is indicated for the topical treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present.
- Aklief (trifarotene) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Aklief must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Aklief Eruopean Union (EU)-Risk Management Plan (RMP) (version 1.3, dated 9 December 2019; data lock point (DLP) 14 March 2018), with Australian Specific Annex (version 1.1, August 2020), included with submission PM-2020-01095-1-1, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of this approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of this approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
Once the EU reference dates are available, reports are to be provided in line with the published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of this approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on good pharmacovigilance practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.