euclinicalgmprequirementandqprelease-临床gmp.pdfVIP

欧盟欧盟欧盟欧盟：：临床阶段的临床阶段的临床阶段的临床阶段的GMPGMPGMPGMP要求和要求和要求和要求和QPQPQPQP放行放行放行放行 DDr SiSiegffriiedd SSchhmittitt, PAREXELPAREXEL EU GMP REQUIREMENTS AT THE CLINICAL DEVELOPMENT STAGE QP RELEASE AGENDA GMPs for Investigational Medicinal Products (IMP) and theirtheir QualifiedQualified PersonPerson (QP)(QP) releaserelease NNew ddevellopmentts andd requiirementts iin ththe EUEU INVESTIGATIONAL MEDICINAL PRODUCTS ((IMP)) Definition of Investigational Medicinal Products (IMPs) “a pharmaceutical form of an active substance or placebo being tested or used as a refference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form.” An IMP must be registered in the EudraCT database /3rya6w7 NON INVESTIGATIONAL MEDICINAL PRODUCTS (NIMP) Definition of Non Investigational Medicinal Products (NIMPs) Products which are not the object of investigation (i.e. other than the tested product, placebo or active comparator)) may be supplied to subjects participating in a trial and used in accordance with the protocol. For instance, some clinical trial protocols require the use of medicinal products such as support or rescue/escape medication for preventive, diagnostic or therapeutic reasons and/or to ensure that adeqquate medical care is pprovided for the subjject. Theyy mayy also be used in accordance with the protocol to induce a physiological response. /3rya6w7 THE QUALIFIED PERSON ((QP)) The person defined in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC The QP is the only person that can release product to be placedplaced onon thethe marketmarket inin thethe EUEU The QP is personally liable for the release decision The regu