Aktualności
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
...
EMA: Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples
10.05.2012
The purpose of this reflection paperi is to provide laboratories that perform the analysis or evaluation of human samples collected as part of a clinical trial, with information that will help
...
Polish Ministry of Health: Regulation of Polish Minister of Health on document templates submitted in relation to the clinical trial of the medicinal product and amount and way of payment for the submission of an application for the starting point of clin
10.05.2012
This document is a Regulation of Polish Minister of Health concerning document templates submitted in relation to the clinical trial of the medicinal product and payments for the submission of an
...
