Multi-country review meetings (POP TCONs)Īpplication submission to POPs ≤ 1 month of FDA submissionĪpplication submission to POPs > 1 month of FDA submission TGA will determine which type of collaboration is possible based on the Orbis types and our existing workload and priorities. There are three types of Project Orbis collaborations based on the level of alignment between the submission to the FDA and the POPs. Any differences should be clearly indicated in the application cover letter. the same data set for Modules 2-5 (noting country-specific aspects) as submitted to the FDA and other participating agencies. In addition, sponsors should submit the 'Sponsor Authorization Letter' (SAL) submitted to the FDA and the ' Assessment Aid' document in their dossier.įor Type A and B Orbis applications (see below), it is generally expected that the sponsor submits a 'global dossier', i.e. The dossier should comprehensively address all Australian specific requirements, including Module 1 and the RMP (if applicable), and must be submitted using the electronic Common Technical Document format (eCTD). Sponsors are encouraged to consider the Priority review pathway should they want a shorter target evaluation timeframe and flexibility of the priority review process. Applications may be submitted through the standard, provisional or priority review pathways. TGA does not have specific criteria to determine whether applications are suitable for Project Orbis. TGA considerations for participation in Project Orbis Please include 'Project Orbis' in the subject line of your email. Once the potential Project Orbis partners are identified, the FDA will send a proposal to the Project Orbis partners (POPs) to confirm their interest and availability to participate in a collaborative review process (see collaboration models below).Īustralian applicants who have the opportunity to take part in Project Orbis should contact the TGA at to discuss the suitability of their application. Applications are generally expected to meet the criteria for "FDA Priority Review". Project Orbis is intended for high-impact and clinically significant applications. new active substances (new chemical entity or new biological entity applications).The FDA coordinates the selection of applications for Project Orbis in collaboration with the US applicant.Īpplications eligible for Project Orbis include oncology products that are either: Applicant and application selection Requirements for applications Medicines approved through Project Orbis collaboration are published on the TGA website on the Prescription medicines & biologicals: new registrations page. Since then, TGA has participated in many Project Orbis submissions. The TGA has been a partner in Project Orbis since its inception in May 2019, working with the FDA and Health Canada on the first Project Orbis submission to approve lenvatinib (Lenvima®) in combination with pembrolizumab (Keytruda®) for the treatment of certain patients with advanced endometrial carcinoma in September 2019. United Kingdom - Medicines and Healthcare products Regulatory Agency (MHRA).
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