EMA: Scientific guideline: ICH guideline E2F : Note for guidance on development safety update report - Step 4

The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are ...

FDA: Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies

This document provides guidance to sponsors and investigators on safety reporting requirements for human drug and biological products2 that are being investigated under an investigational new drug ...

Polish Registration Office: Information of the President of Registration Office (EDQM Standard Terms)

Information of the President of Registration Office concerning supplement to Almanach related to EDQM Standard Terms. ...

Polish Ministry of Health: The project of the Act concerning Office of Registration of Medicinal Products, Medical Devices and Biocidal Products

The Act determines the responsibilities of the President of the Registration Office and operating principles of the Registration Office. ...

EMA: Regulatory and procedural guideline: Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples

The purpose of this guidance document is to provide laboratories that perform the analysis of samples collected as part of a clinical trial, with information that will help them develop and ...

European Medicines Agency welcomes adoption of new pharmacovigilance legislation by European Parliament

22/09/2010 - The European Medicines Agency welcomes the adoption of the new pharmacovigilance legislation by the European Parliament today. This is a major step towards the legislation coming into ...

EMA: Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of Chronic Obstructive Pulmonary Disease (COPD)

This guideline is a revision of the CPMP Points to Consider on Clinical Investigation of Medicinal Products in the Chronic Treatment of Patients with Chronic Obstructive Pulmonary Disease ...

EMA: Scientific guideline: Concept paper on the need for the guidance on the clinical investigation of medicinal products to slow progression of renal insufficiency

Renal insufficiency and end-stage renal disease has a major impact on public health and several medicinal compounds have been licensed or are under development with the aim to halt or slow renal ...

EMA: Scientific guideline: Guideline on missing data in confirmatory clinical trials

This guideline provides advice on how the presence of missing data in confirmatory clinical trials should be addressed and reported in a dossier submitted for regulatory review and provides an ...

MHRA: Braille on packaging for medicinal products

The British Standards Institute has recently published BS EN 15823:2010 Packaging. Braille on the packaging of medicinal products. This specifies the requirements and provides guidance for the ...

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