News
GMP: EMA issues new Guideline on "Chemistry of Active Substances"
05.01.2017
A medicinal product authorization application requires comprehensive information on origin and quality of an active substance. What information is required was defined in two Guidelines so far:
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on confirmation by EMA recommendation to carry out tests to detect hepatitis B among patients treated with antir
05.01.2017
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on confirmation by EMA recommendation to
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Regulatory information – New guidance on type II variations and marketing authorisation extensions for orphan-designated medicines
07.12.2016
Guidance reflects European Commission’s notice on the application of the Orphan Regulation
The European Medicines Agency (EMA) has updated its post-authorisation guidance on extensions of
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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
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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
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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
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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
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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
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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
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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
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