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EMA: Concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

23.01.2014
In the recent past, several requests submitted for EMA scientific advice contained questions concerning the adequacy of planned inferential statistical approaches to compare quality attributes.For ...

GMP: Good Practice Guidelines for Blood Establishments as a Co-Operation between the EDQM/CoE and the EU Commission published

23.01.2014
This document will show the necessary elements of a quality system of blood establishments and hospital blood banks that are required to comply with EU Directive 2005/62/EC. ...

GMP: How to submit an Active Substance Master File?

23.01.2014
As part of the authorisation procedure for a medicinal product, applicants have to provide detailed information about the quality of the API. Generally, the applicant doesn\'t manufacture the API ...

GMP: Implementation of Good Distribution Practices: Explanatory Notes from MHRA

16.01.2014
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a document to clarify the interpretation of the new EU Good Distribution Practice (GDP) Guideline. The document should ...

FDA: Guidance: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics

16.01.2014
This draft guidance is intended to describe FDA’s current thinking about how manufacturers, packers, and distributors (firms), that may either be the applicant or acting on behalf of the ...

Polish Ministry of Health: The Regulation of Polish Minister of Health of January 10, 2014 concerning the application template for marketing authorization of medicinal product.

16.01.2014
This Regulation of Polish Minister of Health of January 10, 2014 concerns the application template for marketing authorization of medicinal product. ...

MHRA: Informal agreement on clinical trials regulation

16.01.2014
Under the current Directive, the number of clinical trials declined and although this cannot be attributed to the Directive only, the Directive did fail to harmonise requirements across the EU. ...

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 ...