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EMA: ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/ biological entities) Step 4

31.05.2012
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q11 on development and manufacture of drug substances ...

EMA: Concept paper on the need for a guideline on multiplicity issues in clinical trials

31.05.2012
The CHMP points to consider on multiplicity issues in clinical trials came into operation in 2002. Since then, it has been proven to be useful for both, industry and regulators when planning and ...

EMA: ICH guideline E14 - questions and answers

31.05.2012
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): E14 questions and answers - Step 5 ...

EMA: Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation

24.05.2012
The document clarifies some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year. ...

EMA: Electronic submission of veterinary dossiers: Questions and answers

24.05.2012
This question and answer document aims to address frequently asked questions and provide guidance to applicants in regard to technical and practical aspects of the EMA’s current policy on ...

EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

24.05.2012
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on ...

EMA: National-competent-authority requirements for periodic-safety-update-report submission during the transitional period

24.05.2012
This document aims at making publicly available the submission requirements of all Member States as regard Periodic Safety Update Reports (PSURs) during the transitional period, starting from July ...

EMA: Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

17.05.2012
This guideline addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of IMP containing biological / biotechnology derived substances in cases ...

EMA: European Medicines Agency guidance for companies requesting scientific advice (veterinary)

17.05.2012
The guidance document addresses a number of questions that users of the scientific advice procedure may have. The guidance also provides an overview of the procedure to obtain scientific advice ...

FDA: S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

17.05.2012
This guidance is intended primarily to recommend a basic framework for the preclinical safety evaluation of biotechnology-derived pharmaceuticals. It applies to products derived from characterized ...