Skip to main content
UploadLanguage (EN)Support
BusinessMobileSocial MediaMarketingTechnologyArt & PhotosCareerDesignEducationPresentations & Public SpeakingGovernment & NonprofitHealthcareInternetLawLeadership & ManagementAutomotiveEngineeringSoftwareRecruiting & HRRetailSalesServicesScienceSmall Business & EntrepreneurshipFoodEnvironmentEconomy & FinanceData & AnalyticsInvestor RelationsSportsSpiritualNews & PoliticsTravelSelf ImprovementReal EstateEntertainment & HumorHealth & MedicineDevices & HardwareLifestyle
Uploaded byDeeptiGupta154
PPTX, PDF1,824 views

Investigation of medicinal product dossier

This document discusses the investigation of medicinal product dossiers (IMPDs) which are required for clinical trial approval in the European Union. There are two main steps for drug approval: clinical trial application and marketing authorization application. IMPDs contain information about the investigational medicinal product including protocols, informed consent forms, and risk management plans. IMPDs can be full or simplified depending on previous submissions. An investigator brochure is also required and provides clinical and non-clinical data on the investigational product to investigators. It differs from an IMPD which focuses more on development and manufacturing details.

Education◦
Downloaded 41 times
INVESTIGATION OF MEDICINAL PRODUCT DOSSIER Diptee Gupta M.Pharm 1ST year Pharmaceutics CSJM University Kanpur 1
DRUG APPROVAL PROCESS- There are 2 regulatory steps to go through before a drug is approved to be marketed in European Union (EU). The 2 steps are-  Clinical trial application  Marketing authorization application  Clinical trial application are approved at the member state level where as Marketing authorization application are approved both at member state or centralized level.  There are some qualified persons who certify that INVESTIGATION OF MEDICINAL PRODUCT DOSSIER (IMPD) should be manufactured according to GMP. 2
So definition of IMPD as – “It is the basis for approval of clinical trials by the competent authority in the EU. The clinical trial directive came in force to harmonizing the laws, regulations and administrative provisions of member states relating to the implementation of GCP in the conduct of clinical trials on medicinal products for human use.” The directive introduce a harmonized procedure for authorization to perform clinical study in any one of the EU member state. In addition it defines the investigation to be submitted to the ethics committee as well as IMPD should be submitted to the competent authority for approval. 3
DOSSIER It defined as- “A collection of documents should a particular person, event or subject.” eg. Patient Medical Dossier, M.Pharm Academic Dossier. TYPES OF IMPD- The EU has provided for two types of IMPDs, a “Full IMPD” and a “Simplified IMPD”, based on whether the product has been described previously in another CTA or a marketing authorization application. Guidance on the structure and content of an IMPD is provided by the European Commission (EC) in ENTR/F2/BL D(2003) CT1 Revision 2, dated October 2005. 4
When applying for a clinical trial authorization-  A full IMPD is required when little or no information about an IMP has been previously submitted to competent authorities, when it is not possible to cross- refer to data submitted by another sponsor and/or when there is no MA in the Community.  A simplified IMPD may be submitted if information has been assessed previously as part of a Marketing Authorization in any MS or a clinical trial to that competent authority. Full and Simplified IMPD- 5
IMPDs are submitted as a part of Clinical trial application DOSSIER by competent regulatory authorities within EU. It contain following parts-  Protocols  Informed consent forms  Investigator brochure  Study reports  Subject narratives  Risk management plan Content of IMPD- 6
The IMPD required will depend on many factors including- 1. Risk aspects 2. Nature of product 3. State of development 4. Patient population 5. Nature and severity of illness 6. Type and duration of clinical trial itself Thus IMPD also defined as- “It is one of several pieces of investigational medicinal product (IMP) related data required whenever the performance of clinical trial is intended in one or more EU member states.” 7
INVESTIGATOR BROUCHRE (IB) Defined as- “It is a compilation of clinical and non-clinical data on the investigational product that are relevant to the study of products in human subjects.” Purpose of IB-  To provide information to the investigator and others involved in the trials such as dose, dose frequency, dose interval, methods of administration and safety monitoring procedures.  Provide insight to support the clinical management for carryout clinical trial study.  The information should be presented in a concise and simple manner.  IB enable a clinician, or potential investigator, to understand it and make his own risk- benefit assessment of the proposed trial. 8
Contentof IB- It should include- a) Title page –  Sponsor name  The identity of each investigational product (i.e. research number, chemical or approved generic name & trade name  The release date  Confidentially statement b) Table of contents c) Summary – Not exceeding 2 pages. Highlighting the physical, chemical , pharmaceutical , pharmacological, toxicological, pharmacokinetic, metabolic and clinical information available of IP 9
d) Introduction-  Chemical name  Active ingredients  Pharmacological class  Anticipated – therapeutic / diagnostic indications e) Description of IP- storage and handling structural similarity of any other compound. f) Non clinical studies- it may include following information-  Species tested  Number of sex in each group  Unit dose (eg. mg/kg)  Dose interval  Route of administration  Duration of dosing 10
g) Effects in humans- Pharmacokinetics and product metabolism in humans Safety and efficacy Marketing experience h) Summary of data and guidance for the investigator- it contain nonclinical and clinical data of IP. Thus IB provide the investigator a clear understanding of –  The possible risks  Adverse reaction  Observation and precautions needed for the clinical trial 11
Difference between IMPD and IB- IMPD IB It mainly focuses on non-clinical data & it details the  Method of development  Manufacture  Packaging, storage. It mainly focuses on clinical as well as non-clinical data. 12
THANK-YOU 13