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GMP: ECA and PQG publish next chapter of the GDP Interpretation Guide

04.09.2014
The Pharmaceutical Quality Group (PQG) and the GDP Interest Group of the ECA Foundation have established a task force which is currently working on the interpretation of the EU Good Distribution ...

EMA: The European regulatory system for medicines and the European Medicines Agency - A consistent approach to medicines regulation across the European Union

28.08.2014
This booklet is intended to explain how the European regulatory system for medicines operates. It describes how medicines are authorised and monitored in the European Union (EU) and how the ...

EMA: Draft template for the qualified person’s declaration concerning good-manufacturing-practice compliance of the active substance used as starting material and verification of its supply chain \'the QP declaration template\'.

28.08.2014
The objective of the QP Declaration Template is to emphasise the importance of providing a valid declaration, to harmonise the format for the declaration, to forestall questions during assessment, ...

GMP: Which SOPs are required by GMP?

28.08.2014
The ECA Academy is receiving a lot of questions on SOPs (Standard Operating Procedures) needed in a GMP environment. The most interesting is the one on which SOPs are required by law. ...

RAPS: FDA Outlines New Communication Process for Generic Drug Companies

28.08.2014
The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, this time explaining the nuances of how generic drug companies ...

RAPS: FDA Guidance Aims to Clarify Development of Medical Countermeasures

28.08.2014
A new final guidance document issued by the US Food and Drug Administration (FDA) aims to make it easier to develop in vitro diagnostic devices (IVDs) intended to act as microbiological or medical ...

EMA: Recommendations for the implementation of the exemptions to the labelling and package-leaflet obligations in the centralised procedure

21.08.2014
This document aims to present the principles for the handling of the exemptions to the labelling and package leaflet obligations. ...

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

21.08.2014
This guidance document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are ...

FDA: Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format - draft guidance

21.08.2014
This guidance is intended to assist applicants in preparing the Clinical Pharmacology section of product labeling to meet regulatory requirements and ensure appropriate consistency in the format ...

FDA: Guidance for industry: Immunogenicity Assessment for Therapeutic Protein Product

21.08.2014
This guidance is intended to assist manufacturers and clinical investigators involved in the development of therapeutic protein products for human use. In this document, FDA outlines and ...