Ngenla
Registration timeline
The following table summarises the key steps and dates for this application.
This application was evaluated as part of the Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium, with work-sharing between TGA and Health Canada. Each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 4 January 2021 |
| First round evaluation completed | 28 May 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 29 July 2021 |
| Second round evaluation completed | 21 September 2021 |
| Delegate's overall benefit-risk assessment | 16 November 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 23 November 2021 |
| Completion of administrative activities and registration on ARTG | 30 November 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 182 |
*Statutory timeframe for standard applications is 255 working days
The recommended dose is 0.66 mg/kg body weight administered once weekly by subcutaneous (SC) injection.
Ngenla dosage may be adjusted as necessary, based on growth velocity, body weight and serum insulin-like growth factor 1 (IGF-1) concentration.
For further information refer to the Product Information.
Ngenla (somatrogon) was approved for the following therapeutic use:
Ngenla is indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.
- Ngenla (somatrogon) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Ngenla 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 Ngenla European Union (EU)-risk management plan (RMP) (version 0.2, dated 30 August 2021, data lock point (DLP) 21 December 2020), with Australian specific annex (version 0.3, dated 24 September 2021), included with Submission PM-2020-05916-1-5, to be revised to the satisfaction of 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 the 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 the 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.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates 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 the 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 90 calendar days of the DLP for that report.
- Laboratory testing and compliance with certified product details
- All batches of Ngenla (somatrogon) supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the certified product details (CPD).
- When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the products. Outcomes of laboratory testing are published biannually in the TGA database of laboratory testing results and periodically in testing reports on the TGA website.
Certified product details
The CPD, as described in Guidance 7: Certified product details of the Australian regulatory guidelines for prescription medicines (ARGPM), in portable document format (PDF), for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- For all injectable products the PI must be included with the product as a package insert.