EN PL

News

GMP: New Concept Paper of the European Commission on the Use of Safety Features against Falsified Medicinal Products

15.12.2011
On 18 November 2011, the European Commission published a concept paper entitled \"Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use, and its ...

MHRA: Public Consultation (MLX 374): Transposition of Pharmacovigilance Directive 2010/84/EU

15.12.2011
Consultation MLX374 seeks your views on the draft regulations transposing the EU Directive 2010/84/EU on Pharmacovigilance. This Directive must be transposed to UK law by 21 July 2012. This is ...

FDA: Draft Guidance for Industry and Food and Drug Administration Staff Humanitarian Use Device (HUD) Designations

15.12.2011
Comments and suggestions regarding this draft document should be submitted within _90_ days of publication in the Federal Register of the notice announcing the availability of the draft guidance. ...

FDA: Regulatory Classification of Pharmaceutical Co-Crystals

07.12.2011
This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research’s current thinking on the ...

GMP: New Concept Paper of the European Commission on the Use of Safety Features against Falsified Medicinal Products

07.12.2011
On 18 November 2011, the European Commission published a concept paper entitled \"Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use, and its ...

EMA: Fees for type IA variations to be due at start of procedure

07.12.2011
The European Medicines Agency is informing marketing-authorisation holders that from 1 January 2012, fees for type IA variations will be due at the start of the 30-day procedure ...

EMA: Qualification opinion of Alzheimer’s disease novel methodologies/biomarkers in predementia AD clinical trials

07.12.2011
In follow-up to the positive Qualification Opinion on the use of cerebrospinal fluid (CSF) biomarkers in predementia AD adopted on 14-Apr-2011 (EMA/CHMP/SAWP/102001/2011), BMS is requesting an ...

EMA: Draft guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)

30.11.2011
This document provides guidance on the data requirements to support authorisation of combined vaccines and a claim for the use of two or more IVMPs, each with its own separate marketing ...

EMA: Guideline on the design of studies to evaluate the safety and efficacy of fish vaccines

30.11.2011
This document provides information on items to be considered in the design and conduct of studies to support the safety and efficacy of immunological veterinary medicinal products (IVMPs) in ...

FDA: Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals

30.11.2011
The objective of this guidance is to provide recommendations to industry for designing nonclinical late radiation toxicity studies to determine potential late radiation effects of therapeutic ...