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IMP s and NIMP s

IMP = Investigational Medicinal Product. Multi-centre trials - requirement for a common understanding of the definition of an IMP.In order to classify a medicinal product as an IMP, you need to think about;a) The intended use of the medicinal productb) The definition of a clinical trial (algor

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IMP s and NIMP s

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    1. IMPs and NIMPs Johanna Piper, Research Governance & GCP Manager Trial Staff Forum, September 2006

    2. IMP = Investigational Medicinal Product Multi-centre trials - requirement for a common understanding of the definition of an IMP. In order to classify a medicinal product as an IMP, you need to think about; a) The intended use of the medicinal product b) The definition of a clinical trial (algorithm) i.e. what are the objectives of the study?

    3. Definition of an IMP Directive 2001/20/EC A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with marketing authorisation but used or assembled (formulated or packaged) in a different way from the authorised form or when used for an unauthorised indication, or when used to gain further information about the authorised form

    4. Criteria defining an IMP Whether a MP is an IMP depends on the aim of the study. If the aim is to discover or verify the MPs; Clinical, pharmacological and/or pharmacodynamic effects Identify any adverse reactions a/w its use Study its absorption, distribution, metabolism and excretion Medicinal products with Marketing Authorisation (MA) are classified as IMPs when they are used as the test substance or reference in a clinical trial.

    5. Medicinal products which are not IMPs Products which are NOT the object of the investigation (i.e. other than the tested product, placebo or active comparator) may be supplied to participants in a trial and used as per protocol. These are Non-Investigational Medicinal Products (NIMPs) and are outside European Directive 2001/20/EC & Regulations. However, European Commission have provided guidance on the use of NIMPs.

    6. Rescue medication Medicines identified in the protocol as those that may be administered to patients when the efficacy of the IMP is not satisfactory or the effect of the IMP is too great and is likely to cause havoc to the patient or in an emergency situation. Rescue medication allows patients to continue on the trial e.g. placebo controlled trials where standard treatment is available. Use should be stated in protocol generally only patients on placebo arm or if study drug ineffective.

    7. Examples of NIMPs Ineffective treatment e.g. pain relief in analgesic trials where placebo being used. Anticipated adverse reactions treatment of expected adverse reactions. Symptom relief e.g. testing a non-oncology medication such as a new pain relief vs active comparator in a cancer patient. Anti-cancer treatment is not the IMP.

    8. Types of treatments in trials Background medication All patients receive usual treatment & the new IMP is given additionally as well as the background treatment; aim is to assess effect of adding the IMP. Standard treatment e.g. development of a new medicinal product for HIV cannot be tested against a placebo. Protocol may state that compare the test compound to an active comparator; each of these would be an IMP

    9. Requirements for NIMPs It is recommended that medicinal products with MA in the Member States concerned are used as NIMPs when possible. Providing info on the NIMP to the MHRA Recommended that a NIMP dossier is submitted to MHRA with info of the proposed use in the trial. NIMP use should be stated in the protocol. NIMPs w/out MA in EU sponsor should review the safety, ensure quality of NIMP.

    10. Safety reporting of NIMPs Sponsor responsible for safety of trial subjects. Reporting SARs related to NIMPs does not apply. Requirement for PI to report AEs not specifically related to IMPs therefore should inform sponsor of SAEs & take appropriate urgent safety measures SAR suspected to be related to an interaction between an IMP and a NIMP should be reported. Any safety issues in subjects can be reported.

    11. More information Draft European Commission document, Aug 06 http://ec.europa.eu/enterprise/pharmaceuticals/pha rmacos/docs/doc2006/07_2006/def_imp_2006_07 _27.pdf

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