News Archive

EMA updates procedural advices for users of the Centralized Procedure

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

Pre-authorisation procedural advice...[more]

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

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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...[more]

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

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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

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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

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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)

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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

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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]

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