ICH-E Guidelines

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ICH-E Guidelines:

ICH-E Guidelines

Efficacy Guidelines:

Efficacy Guidelines The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials.  It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.

Efficacy Guidelines:

Efficacy Guidelines Clinical Safety E1-E2F Clinical Study Reports E3 Dose Response Studies E4 Ethnic Factors E5 Good Clinical Practice E6 Clinical Trials E7-E11 Guidelines for Clinical Evaluation by Therapeutic Category E12 Clinical Evaluation E14 Pharmacogenomics E15-E16 Joint Safety / Efficacy Topic M3

E1 (Oct. 1994):

E1 (Oct. 1994) E1 – The Extent Of Population Exposure To Assess Clinical Safety For Drugs Intended For Long-term Treatment Of Non-life-threatening Conditions The tripartite harmonized ICH Guideline was finalised under Step 4 in October 1994. This document gives recommendations on the numbers of patients and duration of exposure for the safety evaluation of drugs intended for the long-term treatment of non-life-threatening conditions. Events where the rate of occurrence changes over a longer period of time may need to be characterized depending on their severity and importance to the risk-benefit assessment of the drug. The safety evaluation during clinical drug development is not expected to characterise rare adverse events, for example, those occurring in less than 1 in 1000 patients.

E2A (Oct. 1994):

E2A (Oct. 1994) Clinical Safety Data Management: Definitions And Standards For Expedited Reporting E2A There are two issues within the broad subject of clinical safety data management that are appropriate for harmonization at this time: (1) the development of standard definitions and terminology for key aspects of clinical safety reporting, and (2) the appropriate mechanism for handling expedited (rapid) reporting, in the investigational (i.e., pre-approval) phase.

E2B-R2 (Feb. 2001):

E2B-R2 (Feb. 2001) Maintenance Of The ICH Guideline On Clinical Safety Data Management : Data Elements For Transmission Of Individual Case Safety Reports E2B(R2) to standardize the data elements for transmission of individual case safety reports by identifying, and where necessary or advisable, by defining the data elements for the transmission of all types of individual case safety reports, regardless of source and destination.

E2C-R1(Nov. 1996):

E2C-R1(Nov. 1996) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs E2C (R1) guidance on the format and content of safety updates, which need to be provided at intervals to regulatory authorities after products have been marketed. The Guideline is intended to ensure that the worldwide safety experience is provided to authorities at defined times after marketing with maximum efficiency and avoiding duplication of effort. E2C(R2) This Revision was endorsed by Steering Committee in Dec.2010. It will Evaluate the ICH Pharmacovigilance documentation, conduct a gap and potential improvement analysis of ECH E2C, E2E and E2F and draft a new ICH E2C R2 covering periodic benefic risk evaluation reporting.

E2D (Nov. 2003):

E2D (Nov. 2003) Post Approval Safety Data Management: Definitions and Standards for Expedited Reporting provides a standardized procedure for post-approval safety data management including expedited reporting to relevant authority. The definitions of the terms and concept specific to post-approval phase are also provided.

E2E (Nov. 2004):

E2E (Nov. 2004) Pharmacovigilance Planning planning of pharmacovigilance activities, especially in preparation for the early post marketing period of a new drug (chemical entities, biotech-derived products, vaccines) Main focus: Safety specification and PV plan that mighty be submitted at the time of license application

E2F (Aug. 2010):

E2F (Aug. 2010) Development Safety Update Report The main focus of the DSUR is data from interventional clinical trials (referred to in this document as "clinical trials") of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors. Intended for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions.

E3 (Nov. 1995):

E3 (Nov. 1995) Structure and Content of Clinical Study Reports is an "integrated" full report of an individual study of any therapeutic, prophylactic or diagnostic agent (referred to herein as drug or treatment) conducted in patients, in which the clinical and statistical description, presentations, and analyses are integrated into a single report, incorporating tables and figures into the main text of the report, or at the end of the text, and with appendices containing the protocol, sample case report forms, investigator related information, information related to the test drugs/investigational products including active control/comparators, technical statistical documentation, related publications, patient data listings, and technical statistical details such as derivations, computations, analyses, and computer output etc.

E4 (March, 1994):

E4 (March, 1994) Dose-response Information To Support Drug Registration Knowledge of the relationships among dose, drug-concentration in blood, and clinical response (effectiveness and undesirable effects) is important for the safe and effective use of drugs in individual patients. concepts of minimum effective dose and maximum useful dose do not adequately account for individual differences and do not allow a comparison, at various doses, of both beneficial and undesirable effects. Any given dose provides a mixture of desirable and undesirable effects, with no single dose necessarily optimal for all patients.

E5 R1 (Feb. 1998):

E5 R1 (Feb. 1998) Ethnic Factors In The Acceptability Of Foreign Clinical Data This document addresses the intrinsic characteristics of the drug recipient and extrinsic characteristics associated with environment and culture that could affect the results of clinical studies carried out in regions and describes the concept of the "bridging study" that a new region may request to determine whether data from another region are applicable to its population.

E6-R1 (May 1996):

E6-R1 (May 1996) Good Clinical Practice describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCPs cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator's Brochure which had been agreed earlier through the ICH process.

E7 (June 1993):

E7 (June 1993) Studies in Support of Special Populations: Geriatrics This document provides recommendations on the special considerations which apply in the design and conduct of clinical trials of medicines that are likely to have significant use in the elderly. It requires special consideration due to the frequent occurrence of underlying diseases, concomitant drug therapy and the consequent risk of drug interaction.

E8 (July 1997):

E8 (July 1997) General Considerations for Clinical Trials This document sets out the general scientific principles for the conduct, performance and control of clinical trials. The Guideline addresses a wide range of subjects in the design and execution of clinical trials.

E9 (Feb. 1998):

E9 (Feb. 1998) Statistical Principles for Clinical Trials This biostatistical Guideline describes essential considerations on the design and analysis of clinical trials, especially the "confirmatory" (hypothesis-testing) trials that are the basis for demonstrating effectiveness. The document will also assist scientific experts charged with preparing application summaries or assessing evidence of efficacy and safety, principally from clinical trials in later phases of development.

E10 (July 2000):

E10 (July 2000) Choice of Control Group and Related Issues in Clinical Trials This document addresses the choice of control groups in clinical trials considering the ethical and inferential properties and limitations of different kinds of control groups. It points out the assay sensitivity problem in active control equivalence / non-inferiority trials that limits the usefulness of trial design in many circumstances.

E11 (July 2000):

E11 (July 2000) Clinical Investigation of Medicinal Products in the Pediatric Population This document addresses the conduct of clinical trials of medicines in pediatric populations. This document will facilitate the development of safe and effective use of medicinal product in pediatrics.

E12 (March 2000):

E12 (March 2000) Principles for Clinical Evaluation of New antihypertensive Drugs It provides a set of "Principles" on which there is general agreement among all three ICH regions covering endpoints and trial designs. It will not be subject to the usual procedures leading to a fully harmonized document.

E14 (May 2005):

E14 (May 2005) The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. This document provides recommendations to sponsors concerning the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarisation. This assessment should include testing the effects of new agents on the QT/QTc interval as well as the collection of cardiovascular adverse events. The investigational approach used for a particular drug should be individualised, depending on the pharmacodynamic, pharmacokinetic, and safety characteristics of the product, as well as on its proposed clinical use. The assessment of the effects of drugs on cardiac repolarisation is the subject of active investigation. When additional data (non-clinical and clinical) are accumulated in the future, this document may be reevaluated and revised.

E15 (Nov. 2007):

E15 (Nov. 2007) Definitions For Genomic Biomarkers, Pharmaco- genomics, Pharmacogenetics, Genomic Data And Sample Coding Categories Pharmacogenomics and pharmacogenetics have the potential to improve the discovery, development and use of medicines.

E16 (Aug. 2010):

E16 (Aug. 2010) Biomarkers Related To Drug Or Biotechnology Product Development: Context, Structure And Format Of Qualification Submissions The Guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E15.

M3 R2 (June 2009):

M3 R2 (June 2009) Guidance On Non-clinical Safety Studies For The Conduct Of Human Clinical Trials And Marketing Authorization For Pharmaceuticals Harmonisation of the guidance for non-clinical safety studies will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.

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