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GMP: Risk-based Approach to APIs Consignments without Written Confirmation

18.07.2013
The provisions of the directive are intended to ensure that API manufacturers in non-EU countries exporting into the EU are registered with their local authorities and subject to adequate ...

GMP: FDA Safety Communication: New boxed warning for thrombosis related to human immune globulin products.

18.07.2013
The analysis of recent data by the U.S. Food and Drug Administration (FDA) has strengthened the association between the use of intravenous, subcutaneous and intramuscular human immune globulin ...

EMA: Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form

11.07.2013
This concept paper addresses the need to update and revise the CPMP/QWP/486/95 note for guidance on manufacture of the finished dosage form (1). This guideline was originally adopted in September ...

FDA: Draft Guidance - Considerations for the Design of Early - Phase Clinical Trials of Cellular and Gene Therapy Products

11.07.2013
This guidance provides recommendations to assist in designing early-phase clinical trials of CGT products. When this guidance is finalized, we believe it will clarify OCTGT’s current ...

FDA: Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality

11.07.2013
This guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, repackers, and others to the ...

EMA: Draft note for guidance on clinical investigation of medicinal products for treatment of asthma

04.07.2013
This document is intended to provide guidance for the clinical evaluation of new medicinal products for the treatment of asthma. ...

EMA: Practical guidance on the extension of Commission decision annexes in the new accession country language

04.07.2013
This Guidance outlines practical considerations concerning the phasing-in of Commission Decisions concerning CAPs in Croatia.The document provides further details on the inclusion of the new ...

EMA: Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

04.07.2013
The reflection paper (RP) should provide an overview of statistical principles with a potential of useful application in the context of the comparison of quality attributes as mentioned above. For ...

EMA: Draft guideline on adjustment for baseline covariate

04.07.2013
The note for guidance on statistical principles for clinical trials (ICH E9) briefly addresses the problem of adjustment for covariates. It advises experimenters ‘to identify the covariates ...

GMP: Guideline on the European Drug Master File Procedure updated

27.06.2013
The \"Guideline on Active Substance Master File Procedure\" which was developed by EMA\'s Quality Woring Party, describes the procedure that can be used to document an API\'s quality for a ...