11/6/2023 0 Comments Orbis research reviewsSubmissions 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.
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