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RAPS: FDA Warns Chinese Drugmaker for Refusing Inspection, Unsanitary Conditions

05.01.2017
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 8 December to China-based Baoying County Fukang Medical Appliance with six violations.   The US Food ...

RAPS: FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars

05.01.2017
Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is ...

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: ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...