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

09.08.2012
This Question and Answer (Q&A) document provides practical considerations concerning the initial phases of operation of the new pharmacovigilance legislation (Regulation (EU) No 1235/2010 and ...

EMA: Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products

09.08.2012
This document aims to provide guidance on how to present the application for registration of traditional herbal medicinal products (THMPs) in the Common Technical Document (CTD) format, providing ...

GMP: Revised Guideline on the ASMF Procedure Coming into Force on 1st October 2012

09.08.2012
The document is supposed to help accomplishing an administrative harmonisation which should facilitate the processing of an ASMF by authorities and improve communication between the ASMF holder, ...

EMA: Final Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD)

09.08.2012
This guideline is a revision of the CPMP Points to Consider on Clinical Investigation of Medicinal Products in the Chronic Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD) ...

EMA: Reflection paper on immune tolerance induction in haemophilia-A patients with inhibitors

02.08.2012
In haemophilia-A patients, replacement therapy with factor-VIII (FVIII) products has become state of the art. However, a serious complication in the treatment of haemophilia A is the development ...

EMA: Draft guideline on core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular administration

02.08.2012
This guideline describes the information to be included in the summary of product characteristics for human normal immunoglobulins for subcutaneous or intramuscular administration. ...

EMA: Guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits

02.08.2012
This module provides guidance on planning and conducting the legally required audits, and in respect of the operation of the European Union regulatory network, the role, context and management of ...

EMA: Guideline on good pharmacovigilance practices: Module XV – Safety communication

02.08.2012
This module provides guidance to marketing-authorisation holders, competent authorities in Member States and the Agency on how to communicate and coordinate safety information in the European Union. ...

EMA: Guidelines on good pharmacovigilance practices (GVP)

02.08.2012
New legislation for pharmacovigilance will apply in the European Union (EU) as of July 2012, and to support its implementation, a new set of guidelines for the conduct of pharmacovigilance in the ...

EMA: Compilation of Community Procedures on Inspections and Exchange of Information

26.07.2012
The Compilation of Community Procedures on Inspections and Exchange of Information, formerly known as the Compilation of Community Procedures on Administrative Collaboration and Harmonisation of ...

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