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FDA: Draft guidance: Size, Shape, and Other Physical Attributes of GenericTablets and Capsules

02.01.2014
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 ...

FDA: Draft guidance: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA

02.01.2014
This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. The guidance describes ...

URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning amendment of fees related to marketing authorization of a medicinal product.

02.01.2014
This document is an announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning amendment of fees related to marketing ...

EMA: Guideline on core summary of product characteristics and package leaflet for technetium (99mTc) sestamibi

19.12.2013
This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for technetium (99mTc) sestamibi. ...

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 ...

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