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EMA: Reflection paper on pharmacovigilance communication concerning veterinary medicinal products

19.12.2013
This document will provide an overview of different types of communication tools used by national competent authorities (NCAs), the European Medicines Agency (EMA or the ‘Agency’) and ...

EMA: Draft recommendation on pharmacovigilance surveillance and signal detection of veterinary medicinal products

19.12.2013
Veterinary medicinal products (VMPs) are granted a marketing authorisation in the European Union (EU) based on demonstration of quality, safety and efficacy through experimental data involving the ...

GMP: FDA plans significant increase of GMP Inspections in China

19.12.2013
The US FDA has elaborated concrete plans to increase the number of inspections in China. These plans were developed as a consequence of the Heparin crisis. Already in 2008, the US FDA opened ...

EMA: Draft sunitinib product-specific bioequivalence guidance

12.12.2013
This document includes requirements for bioequivalence demonstration of sunitinib. ...

GMP: New USP Requirements for Pharmaceutical Packaging Materials and International Standards for the Measurement of Material Permeability Indexes

12.12.2013
This year, the USP has already published many new requirements for pharmaceutical packaging systems in the Pharmacopeial Forum (PF). ...

FDA: Draft Guidance: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

12.12.2013
Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and ...

EMA: Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases

12.12.2013
Vaccine pharmacovigilance has been defined by the CIOMS/WHO Working Group on Vaccine Pharmacovigilance as the science and activities related to the detection, assessment, understanding and ...

EMA: This concept paper is concerned with the revision of the clinical and non-clinical sections of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a registration application for traditional herbal medicinal pr

05.12.2013
This concept paper is concerned with the revision of the clinical and non-clinical sections of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a ...

EMA: Reflection paper on the use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products

05.12.2013
This reflection paper concerns the use of recycled/recovered solvents for extraction of herbal substances in the manufacture of herbal preparations for use in herbal medicinal products (HMPs)/ ...

EMA: World AIDS Day 2013 – Revised guidance to facilitate development of new medicines

05.12.2013
The document provides a new definition of populations included in clinical trials, moving away from a focus on treatment history (distinguishing between treatment-naïve and treatment-experienced ...