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Contract Manufacturing Arrangements for Drugs: Quality Agreements

07.12.2016
This guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current ...

Safety Testing of Drug Metabolites

07.12.2016
This guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The safety of drug metabolites ...

E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

07.12.2016
Pediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration of regulatory and scientific advances relevant to pediatric populations. This addendum ...

1000th Procedure HMA Voluntary Harmonisation Procedure (VHP) for clinical trials

07.12.2016
The European Voluntary Harmonisation Procedure for clinical trials (VHP) was first established in March 2009. Now, the 1000th application for the evaluation of a clinical trial has been received ...

Procedural advice on the certification of quality and non-clinical data for small and medium sized enterprises developing advanced therapy medicinal products

07.12.2016
Article 18 of Regulation (EC) No 1394/20071 provides that Small and Medium-sized Enterprises (SMEs) developing an Advanced Therapy Medicinal Product (ATMP) may submit to the European Medicines ...

RAPS: FDA Warns Teva’s Banned Hungary Manufacturing Facility

17.11.2016
The US Food and Drug Administration (FDA) has warned Teva’s Gödöllő, Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as ...

EMA: EMA encourages companies to submit Type I variations for 2016 by end of November

17.11.2016
The European Medicines Agency (EMA) is advising marketing authorisation holders to submit any Type IAIN and Type IA variations for 2016 by Wednesday 30 November. This will enable the Agency to ...

RAPS: EMA Report Emphasizes Need for Coordinating International Regulatory Initiatives

17.11.2016
The European Medicines Agency (EMA) released what it says is the first comprehensive overview of international regulatory initiatives, calling attention to the need for greater coordination across ...

EMA: Revising the guideline on first-in-human clinical trials

17.11.2016
The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of October 13, 2016 on verification and additions EAN / GTIN for veterinary medicinal products

17.11.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of October 13, 2016 on verification and additions EAN / GTIN ...