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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 ...

EMA: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance

16.10.2014
This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have. It provides an overview of the procedure to obtain scientific ...

RAPS: Chinese Company Used Suppliers Linked to Contaminated Heparin Scandal, FDA Claims

16.10.2014
A Chinese-based manufacturer of heparin products has been sent a Warning Letter by the US Food and Drug Administration (FDA) after regulators accused the company of preventing FDA inspectors from ...