News Archive

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

10.03.2015
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An updated list of "Requirements on Submissions for Periodic safety update reports (PSUR) to National Competent Authorities (NCAs) for products authorised via National...[more]

EMA issues another update of the Post-Authorisation Procedural Advice

08.03.2015
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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...[more]

Poland starts CESP pilot

15.12.2014
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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...[more]

CMDh releases updated submission requirements (number and format)

14.11.2014
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Updated submission requirements were released by the CMDh for applications within MRP, DCP or National procedures. 

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

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

06.11.2014
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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...[more]

South Africa MCC updates eCTD implementation roadmap

27.10.2014
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The Medicines Control Council (MCC) of South Africa has updated their roadmap for the implementation of the eCTD. Since June last year an eCTD pilot phase is running at the MCC...[more]

Australian TGA updates eCTD FAQ

24.10.2014
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The Australian Therapeutics Good Administration has updated their "Australian eCTD submissions: Frequently asked questions" website (see also link at the bottom of this...[more]

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