This document provides guidance to sponsors on developing a systematic approach for 16 investigational new drug application (IND) safety reporting for human drugs and biological 17 products2 developed under an IND. 

This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product- or Population-Specific Considerations. 

This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials. These drugs, which include biological drugs, are exempt from complying with 21 CFR part 211 under 21 CFR 210.2(c) (referred to as phase 1 investigational drugs). 

This directive is on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

The Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. These guidelines may be overridden by national legal requirements and the requirements of individual regulatory agencies as appropriate, to address matters relevant to local conditions or culture. 

This document guides and instructs the main panels and sub-panels of the 2008 Research Assessment Exercise (RAE 2008) on developing their assessment criteria and working methods for RAE 2008 and on their assessment of submissions. It also provides general information to higher education institutions on RAE 2008, including on criteria setting and assessment processes.

Innovations in medical practice are critical to the advancement of medicine. Good clinicians constantly adapt and modify their clinical approaches in ways they believe will benefit patients. Innovative practice frequently is approached very differently from formal research, which is governed by distinct ethical and regulatory frameworks. Although opinions differ on the distinction between research and innovative practice, the production of generalizable knowledge is one defining characteristic of research. Physicians considering innovative practice must disclose to patients the purpose, benefits, and risks of the proposed treatment, including risks not quantified but plausible. If there is any question whether innovative practices should be formalized as research, clinicians should seek advice from the relevant institutional review board.