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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 ...

EMA: Regulatory procedural Advice on similar biological medicines

17.05.2012
In April, the European Medicines Agency (EMA) published a new document on regulatory procedural advice on similar biological medicines. This paper is supposed to complement existing guidelines by ...

EMA: eSubmission Gateway for Centralised Authorisations - Questions and answers

17.05.2012
For some time now, the EMA has only been accepting the submission of documents in electronic form for the centralised procedure. So far, there have been 2 possibilities to submit documents: either ...

EMA: Reflection paper on classification of advanced-therapy medicinal products

10.05.2012
The aim of this reflection paper is to introduce the advanced-therapy medicinal product (ATMP) classification procedure by means of clarifying the legal basis for ATMP classification, providing ...