News Archive

EMA updates procedural advices for users of the Centralized Procedure

17.03.2015
Flag of EU

EMA has released an update of the following procedural advice documents for users of the EU Centralized Procedure (Human Medicines):

Pre-authorisation procedural advice...[mehr]

Start of the eCTD Version 4 EU M1 Implementation Guide Public Consultation

16.03.2015
Flag of EU

The EU eSubmission Change Management Board (CMB) has announced the start of the public consultation period for the eCTD 4.0 EU Module 1 Implementation Guide.

Stakeholders from...[mehr]

Requirements on Submissions for PSURs updated (MRP/DCP, National)

10.03.2015
Flag of EU

An updated list of "Requirements on Submissions for Periodic safety update reports (PSUR) to National Competent Authorities (NCAs) for products authorised via National...[mehr]

EMA issues another update of the Post-Authorisation Procedural Advice

08.03.2015
Flag of EU

EMA has released a new update of the "Post-Authorisation Procedural Advice for Users of the Centralised Procedure" (Human Medicines). The new version Rev.47 is dated...[mehr]

Poland starts CESP pilot

15.12.2014
Flag of Poland

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland has started a CESP Pilot Phase on December 15, 2014.

During the pilot phase...[mehr]

CMDh releases updated submission requirements (number and format)

14.11.2014
Flag of EU

Updated submission requirements were released by the CMDh for applications within MRP, DCP or National procedures. 

The submission requirements overview tables, dated...[mehr]

EMA releases another update of the Pre-Authorisation Procedural Advice for CP users

06.11.2014
Flag of EU

A new update of the "Pre-Authorisation Procedural Advice" for users of the Centralized Procedure (Medicines for Human Use) has been released.

The new version, dated...[mehr]

Treffer 22 bis 28 von 376

< Vorherige

1

2

3

4

5

6

7

Nächste >

© 2007 - 2018 | Exalon GmbH | Fritz-Reichle-Ring 2 | 78315 Radolfzell | Germany | Phone: +49 (0)7732.939.1650 | Fax: -.1655 | e-Mail:info@exalon.com