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EMA: Guideline on similar biological medicinal products

06.11.2014
This guideline replaces the Guideline on similar biological medicinal products (CHMP/437/04). The document describes and addresses the application of the biosimilar approach, the choice of the ...

EMA: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications

06.11.2014
This document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the ...

EMA: Draft guideline on influenza vaccines – submission and procedural requirements

06.11.2014
The need to update the current guidelines regarding the development of influenza vaccines was recognised in the wake of the 2009-2010 influenza pandemic, as the Agency conducted its “lessons ...

RAPS: FDA Considers New Approach Toward Regulation of Dietary Supplements

06.11.2014
In a Federal Register announcement on 30 October 2014, FDA said it will begin soliciting comments regarding its Red Book guidance with the explicit intent of \"possibly expanding the scope of the ...

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 ...

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