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EMEA: Revised HMPC procedure on management of proposals from interested parties for Community list entries or Community herbal monographs

25.03.2009
EMEA:
Revised HMPC procedure on management of proposals from interested parties for Community list entries or Community herbal monographs. The purpose of this document is to streamline and ...

MHRA: Updated guidance for Marketing Authorisation applications for medicines using the Decentralised procedure with the UK as Reference Member State (RMS)

25.03.2009
MHRA:
Updated guidance for Marketing Authorisation applications for medicines using the Decentralised procedure with the UK as Reference Member State (RMS)
MHRA have revised and ...

MHRA: EU Paediatric Regulation: Revised guidance on undertaking the compliance check

25.03.2009
MHRA:
EU Paediatric Regulation: Revised guidance on undertaking the compliance check. Marketing Authorisation holders are reminded that the obligation for applications for new indications ...

HMA: eCTD Implementation Survey Report

25.03.2009
HMA:
eCTD Implementation Survey Report (covering the period from July 2007 to June 2008) (607.58 kb) March 2009. ...

European Commision: Implementation of the Variations Regulation

25.03.2009
European Commision:
Implementation of the Variations Regulation. Public Consultation Paper for the preparation of guidelines on the operation of the variation procedures. ...

FDA: Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format

25.03.2009
FDA:
This guidance is intended to assist applicants in preparing the Clinical Pharmacology section of product labeling to meet the requirements of FDA regulations (21 CFR 201.57) and to ...

EMEA: Draft guideline on the use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations Rev. 1

28.02.2009
EMEA:
Draft guideline on the use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations Rev. 1.
This ...

EMEA: Concept paper on the need for a guideline on the treatment of premenstrual dysphoric disorder

28.02.2009
EMEA:
Concept paper on the need for a guideline on the treatment of premenstrual dysphoric disorder.
It is aimed that the Guideline on the development of new products for the ...

EMEA: Guideline on clinical development of fixed combination medicinal products

28.02.2009
EMEA:
Guideline on clinical development of fixed combination medicinal products.
This guideline covers fixed combination medicinal products containing two or more active substances, ...

EMEA: Concept paper on the need for revision of the points to consider on clinical investigation of medicinal products in the chronic treatment of patients with chronic obstructive pulmonary disease (copd)

28.02.2009
EMEA:
Concept paper on the need for revision of the points to consider on clinical investigation of medicinal products in the chronic treatment of patients with chronic obstructive ...