What is investigational medicinal product dossier?
An Investigational Medicinal Product Dossier (IMPD) contains data on the quality, production and control of the medicinal product being researched. This information concerns the active product, placebo and reference product (if applicable). It also contains a summary of data from all clinical and non-clinical research.
What is the difference between IMPD and CTA?
The IMPD is the main document of the CTA in the EU used for obtaining the authorization to conduct a clinical trial with an IMP. As the product advances in clinical development, new data are added to the IND whereas a new or updated IMPD is submitted with each CTA.
What is a IMP dossier?
The Investigational Medicinal Product Dossier (IMPD) is one of several pieces of Investigational Medicinal Product (IMP) related data required whenever the performance of a clinical trial is intended in one or more European Union Member States.
What is an imp and Nimp?
It follows that medicinal products with a marketing authorisation are IMPs when they are to be used as the test substance, reference substance or comparator in a clinical trial, provided the requirement(s) in the definition are met. 3. NON-INVESTIGATIONAL MEDICINAL PRODUCTS (NIMPS) 3.1.
What is IEC in clinical research?
IRBs can also be called independent ethics committees (IECs). An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants.
What is CTA in clinical trial?
A Clinical Trial Agreement (CTA) is a legally binding agreement that manages the relationship between the sponsor that may be providing the study drug or device, the financial support and /or proprietary information and the institution that may be providing data and/or results, publication, input into further …
What is NDA and IND?
Drug development is divided into types. The first type is Pre-clinical phase, usually takes 3 to 4 years to complete. If fruitful, this phase is followed by an appeal to the FDA as an Investigational New Drug (IND). The manufacturer then files a New Drug Application (NDA) with the FDA for approval.
What is a drug CTA?
A Clinical Trial Application (CTA) is a submission to the competent National Regulatory Authority(ies) for obtaining authorization to conduct a clinical trial in a specific country. It is an application with necessary information on investigational medicinal products.
What are the sections of an IMPD?
The IMPD is divided into four sections which summarizes the relevant information on quality, pre-clinical, clinical studies, including critical analyses of the non-clinical and clinical data related to the possible risks and benefits of the proposed study, as well as any available previously generated human data and an …
What is Nimp?
Acronym. Definition. NIMP. Non Investigational Medicinal Product (various organizations)
What is auxiliary medicinal product?
The following definitions are included in the Regulation: Auxiliary medicinal products: A medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product.
Is IRB and IEC same?