EMEA: Overview of comments received on the draft guideline on the development of New Medicinal Products for the Treatment of Smoking

SRNT Europe, representing European scientists in the field of nicotine and tobacco research, is concerned that this guideline in its present form will be a barrier to the development of new ...

MHRA: MHRA Patient Information Quality Unit performance figures

MHRA is now publishing performance figures for the Patient Information Quality Unit (PIQU).This follows feedback from the medicines trades associations that separate metrics are needed to aid ...

MHRA: Guidance published on UK exporting of medicines

Guidance helping pharmaceutical manufacturers and distributors to meet their obligations about the supply of medicines, has been jointly published today by nine health organisations including the ...

MHRA: Publication of responses to consultation MLX 358 on European Commission proposals on information to patients

On 10 December 2008 the European Commission published a legislative proposal for the pharmaceutical industry to be able to communicate certain information on prescription medicines directly to ...

MHRA: Updates to BROMI guidance documents added to the Labels, patient information leaflets and packaging for medicines section

Two updated BROMI guidance documents have been added to the Labels, patient information leaflets and packaging for medicines section. MHRA guidance on changes to labelling and patient ...

FDA: E7 Studies in Support of Special Populations

Draft Guidance E7 Studies in Support of Special Populations: Geriatrics Questions & Answers ...

EMEA: Draft community herbal monograph

Draft community herbal monograph on Cimicifugae rhizoma ...

EMEA: Updated inventory of herbal substances for assessment

Inventory of herbal substances for assessment – Alphabetical order ...

EMEA: Updated community herbal monograph

Updated community herbal monograph on: Salicis cortex Salix purpurea L.; Salix daphnoides Vill.; Salix fragilis L., cortex ...

FDA: Dosage Delivery Devices for OTC Liquid Drug Products

This document is intended to provide guidance to firms that are manufacturing, marketing, or distributing over-the-counter (OTC) liquid drug products (e.g., elixirs, suspensions, solutions, ...

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