EMEA: Revised Distribution Requirements and Address Lists for Periodic Safety Update Reports (PSURs)

Annex 6.2 of Volume 9A of the Rules Governing Medicinal Products in the EU ...

FDA: Presenting Risk Information in Prescription Drug and Medical Device Promotion

This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and medical device promotional pieces to determine whether they adequately present risk ...

EMEA: Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Ankylosing Spondylitis

This Guideline is intended to provide guidance for the clinical evaluation of new medicinal products for the treatment of ankylosing spondylitis (AS), a chronic inflammatory disease that affects ...

EMEA: Guideline on the Clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C

The aim of this guideline is to provide guidance on the clinical development of compounds for the treatment of Chronic Hepatitis C (CHC). It should be read in conjunction with updated and ...

EMEA: Clinical Investigation of Medicinal Products used in the Treatment of Osteoarthritis

This document is intended to provide guidance on the clinical evaluation of medicinal products in the treatment of osteoarthritis (OA). OA is a flaring degenerative arthropathy and a disorder ...

EMEA: Questions/answers on Endotoxin Testing and Sterility Testing at the end of shelf-life

Is endotoxin testing considered essential at the end of shelf life to confirm parenterals to be pyrogen-free? Is sterility testing considered essential at the end of shelf life to confirm ...

MHRA: Public consultation (MLX 358): The European Commission proposals on information to patients for prescription medicines

This consultation seeks your views on a European Commission proposal that would allow the pharmaceutical industry to provide information to the public on prescription only medicines (advertising ...

Ministry of Health: Regulation project concerning the changes in The Decree of Ministry of Health relating to the payment for Marketing Authorization of the medicinal products

The regulation project introduce the updated basic amount (from 1126 PLN to 1276 PLN). The payment for MA of the medicinal products is established in relation to the basic amount. ...

EMEA: Guideline on Missing data in confirmatory clinical trials

This guideline provides advice on how the presence of missing data in a confirmatory clinical trial should be addressed in a regulatory submission. ...

MHRA: Additional hypotensive effects following co-administration of non-selective alpha-blockers and phosphodiesterase-5-inhibitors: Guidance for marketing authorisation holders.

Requirement for marketing authorisation holders to submit Type II variations by 15 June 2009 to update licences with additional guidance on hypotensive effects. During the discussion of this ...

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