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This guideline is intended to provide guidance on when and how surrogate endpoints can be used for Relative Effectiveness Assessment (REA). The guideline is not intended to give a comprehensive list of validated surrogate endpoints and how well they predict final clinical endpoints.
The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories: [11] Q: Quality Guidelines; S: Safety Guidelines; E: Efficacy Guidelines; M: Multidisciplinary Guidelines; ICH guidelines are not binding, and instead implemented by regulatory members through national and regional governance. [12]
Equivalent principles of inspection methodology, so that it is understood that inspectors in each member country will be following the same best practices when carrying out inspections. Mechanisms for the training of inspectors. Harmonization of written standards of Good Manufacturing Practices.
The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.
The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). [ 1 ] [ 2 ] After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada [ 3 ] and Switzerland.
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]
Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
Methods of administration Safety monitoring procedures An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a ...