Search results with tag "Registration of pharmaceuticals for human use"
Animals Chapter 9 Animal Use in Toxicity Studies
www.nuffieldbioethics.orgHarmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) also seeks to standardise the approach to testing of pharmaceuticals (see paragraphs 12.8, 13.50 and 15.84). Box 9.2: The EU REACH Initiative: Registration, Evaluation and Authorisation of Chemicals Registration, Evaluation and Authorisation of Chemicals
Introductory Guide for MedDRA - World Health Organization
www.who.intConference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. This guide describes the development, scope, and structure of the terminology. 1.1 BACKGROUND Prior to the development of MedDRA, there had been no internationally accepted medical terminology for biopharmaceutical regulatory purposes.
INTERNATIONAL CONFERENCE ON HARMONISATION OF …
database.ich.orgREQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE - 1 - Concept paper Q7: Good Manufacturing Practices for Pharmaceutical Ingredients Dated and endorsed by the Steering Committee on 5 February 1998 Introduction – Problem statement: Starting materials are all the constituents of a medicinal product, the active pharmaceutical
Q3B(R2) - ICH
database.ich.orgREQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE IMPURITIES IN NEW DRUG PRODUCTS Q3B(R2) Current Step 4 version dated 2 June 2006 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in …
QUALITY RISK MANAGEMENT - ICH
database.ich.orgREQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE QUALITY RISK MANAGEMENT Q9 Current Step 4 version dated 9 November 2005 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in …