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Orbis clinical12/7/2023 If the request is provisionally accepted by the MHRA, the parent US Company will be advised and should provide details of the local UK affiliate to MHRA. Once a product or new indication has been identified for inclusion in Project Orbis, FDA will contact the MHRA to request their interest in involvement. Inclusion of the MHRA in a Project Orbis Procedure Contact specific POP(s) regarding optimal timing for submission of Type C dossier. Multi-country review meetings (POP TCONs)ġ Regulatory action in other jurisdictions is unlikely to occur immediately after FDA action and will follow respective health authority timelines.ĢDependent on Project Orbis Partner (POP) guidelines. Project Orbis Types Orbis TypeĪpplication submission to POPs ≤ 1 month of FDA submissionĪpplication submission to POPs > 1 month of FDA submission If the FDA has already taken regulatory action, a Type C Orbis (Written Report Only Orbis) will allows the FDA to share their completed review documents with MHRA but there is no concurrent review or action with FDA. Type BĪpplications submitted with a greater than 30-day delay or a regulatory action greater than 3 months of the FDA action are termed Type B Orbis (Modified Orbis) and allow the possibility of concurrent review with FDA but no concurrent action. These are termed Type A Orbis (Regular Orbis) and allow for maximal collaboration during the review phase and the possibility of concurrent action with FDA. Type AĪpplications should be submitted concurrently or near-concurrently (within 30 days) to FDA and MHRA. There are three different types of submission depending on the timelines between the FDA and MHRA. MHRA will arrange a meeting with you to discuss eligibility. If you want MHRA to propose a product or new indication for the Project Orbis programme, email Orbis- with a summary of the product explaining how you meet the eligibility criteria. Submissions will also need to meet the FDA’s clinical criteria for priority review. You can find out more in our guidance about ILAP MHRA, NICE and the Scottish Medicines Consortium ( SMC) will collaborate within ILAP and a positive Innovation Passport designation is a requirement for inclusion in the Project Orbis programme. Submissions will only be forwarded to the FDA if they meet the qualifying criteria for the Innovation Passport within the Innovative Licensing and Access Pathway ( ILAP). Initial enquires that MHRA receive will be referred to the FDA. The FDA coordinate the selection of products that will be included. You can find out more on the EMA website. Products eligible for Project OrbisĪpplications submitted to the MHRA within a Project Orbis procedure must be new marketing authorisation applications (MAAs) or new indication applications (variations) for oncology products.Īuthorisations will be applicable in Great Britain only as oncology medicinal products fall within the mandatory scope of the European Medicine Agency (EMA) centralised procedure that applies in Northern Ireland. Each country remains fully independent on their final regulatory decision. Project Orbis Partners (POPs) may propose products for inclusion in the scheme. Brazil (Agência Nacional de Vigilância Sanitária ( ANVISA)).Singapore (Health Sciences Authority ( HSA)).Australia (Therapeutic Goods Administration ( TGA)).Alongside MHRA, it involves the regulatory authorities of: Project Orbis is coordinated by the US Food and Drug Administration ( FDA). It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies. The programme provides a framework for concurrent submission and review of oncology products among international partners.
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