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GMP: New FDA Inspection Guidance gives the Agency more Power

06.11.2014
The U.S. Food and Drug Administration (FDA) is obliged to carry out inspections of facilities at reasonable times, within reasonable limits and in a reasonable manner. However, sometimes the FDA ...

EMA: Guidance on the assessment of persistent, bioaccumulative and toxic or very persistent and very bioaccumulative substances in veterinary medicine (Draft)

30.10.2014
Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) are combinations of substance properties which give substances the potential to accumulate in remote ...

Polish Ministry of Health: The Regulation of Polish Minister of Health of October 17, 2014 amending the Regulation concerning the way of making declarations and notifications for products

30.10.2014
This document is a regulation of Polish Minister of Health amending the Regulation concerning the way of making declarations and notifications for products. ...

EC: New version of Clinical trials

30.10.2014
A complete revision of the chapter on clinical trials has been published on the European Commission website. The Clinical Trials Regulation aims to create an environment that is favourable for ...

GMP: USP\'s New Requirements for Compendial Validation

30.10.2014
An interesting article from the USP on the future requirements for compendial validation has been published in the Pharmacopoeial Forum 39(6). This new chapter will concentrate on the types of ...

RAPS: FDA Wants Input on How to Improve Clinical Trials Process for Industry

30.10.2014
The US Food and Drug Administration (FDA) wants the public\'s feedback on ways it can make it easier to communicate with the agency during the clinical trials process. In an announcement in the ...

GMP: New EMA\'s Reflection Paper on API Starting Materials

23.10.2014
EMA released a document entitled \"Reflection paper in the requirements for selection and justification of starting materials for the manufature of chemical active substances\". The paper was ...

EMA: Substances considered as not falling within the scope of Regulation (EC) no 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin

23.10.2014
Regulation (EC) No. 470/2009 of 6 May 2009 lays down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. The ...

GMP: EDQM revises 5.1.10. Guidelines for using the Test for Bacterial Endotoxins

23.10.2014
In September, the European Directorate for the Quality of Medicines & HealthCare (EDQM) published in Pharmeuropa online the information about their new policy for bacterial Endotoxins, which was ...

MHRA: EMA public consultation on functional specification for portal and database that will underpin the EU Clinical Trials Regulation

23.10.2014
One of the features of the EU Clinical Trials Regulation No 536/2014 is the creation of the EU portal and the EU database for clinical trials. The Regulation and systems infrastructure provided by ...