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EMA: Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with final definition annex revision 2

09.01.2014
New legislation for pharmacovigilance applies in the European Union (EU) since July 2012, and to support its implementation, a new set of guidelines for the conduct of pharmacovigilance in the EU ...

URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning interpretation of the article 12 of act of an act amendment – Pharmaceutical Law and other acts.

09.01.2014
This announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerns risk management plan. ...

GMP: EMA now also issues GMP and GDP Non-Compliance Information

09.01.2014
The European Medicines Agency (EMA) has launched a new version of the EudraGMDP database which includes, among other changes, the publication of statements of non-compliance with Good ...

GMP: USP proposal on temperature control during storage and distribution

09.01.2014
The USP has published a so called stimuli article which is intended to provide a proposal to revise an existing USP monograph. ...

FDA: Qualification Process for Drug Development Tools - Guidance

09.01.2014
This guidance describes the process for qualifying drug development tools intended for potential use, over time, in multiple drug development programs. ...

EMA: Draft guideline on core summary of product characteristics for plasma-derived fibrin sealant / haemostatic products

02.01.2014
This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for plasma-derived fibrin sealant / haemostatic products. ...

FDA: Draft guidance: Size, Shape, and Other Physical Attributes of GenericTablets and Capsules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FDA: Draft guidance: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA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. ...