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HMA: Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures

26.08.2010
Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B. Presentation and format of the dossier Common Technical Document(CTD) ...

EMA: Scientific guideline: Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders

26.08.2010
The scope of this document is restricted to treatment of seizures in epileptic disorder although there are some remarks concerning non-seizure features of epilepsy syndromes. The guideline is ...

MHRA: Variations legislation 2010 - details of our experience to date, submissions audit and update to FAQs

26.08.2010
The new Variations Regulation (EC/1234/2008) took effect on 1 January 2010. This immediately applied to variations to marketing authorisations covered by European procedures. However, the MHRA has ...

FDA: Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment

26.08.2010
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI), impetigo, and minor ...

EMA: Regulatory and procedural guideline: Guideline for the specifications of e-submissions of parallel distribution notification documents

19.08.2010
This Guidance is intended to assist Parallel Distributors (hereinafter referred to as “PD”) with the submission of notifications or notifications of a change for parallel distribution in ...

EMA: Regulatory and procedural guideline: Guidance on centrally authorised products requiring a notification of a change for update of annexes

19.08.2010
On 23 July 2010 and after a consultation phase, the EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any ...

FDA: Guidance for Industry Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide

19.08.2010
This guidance is intended to help small businesses understand and comply with FDA’s organ-specific labeling regulation for over-the-counter (OTC) internal analgesic, antipyretic, and ...

EMA: Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials

13.08.2010
The scope of this reflection paper is electronic systems, (including instruments, software and services) used in clinical trials in the creation/capture of electronic clinical data, such ...

EMA: Terms of reference and procedures for participating authorities (manufacturers of medicinal products)

13.08.2010
The overall objective is to see whether greater international collaboration can help to better distribute inspection capacity, allowing more sites to be monitored and reducing unnecessary ...

MHRA: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures

13.08.2010
In July/August 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published paediatric assessment reports following completion of eight Article 45 work-sharing ...