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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of June 8, 2015 concerning the fulfillment by the bodies responsible with the obligation imposed by Article 24 paragraph.

02.07.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of June 8, 2015 concerning the fulfillment by the bodies ...

RAPS: EMA Gearing up to Publish Clinical Data Ahead of New Clinical Trials Regulation

18.06.2015
The European Medicines Agency (EMA) is moving forward with its plan to release the clinical data used in marketing authorization applications. In April 2014, the European Parliament ...

EMA: Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis

18.06.2015
This document is intended to provide guidance on the clinical evaluation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of rheumatoid arthritis ...

EMA: Reflection paper on classification of advanced therapy medicinal products

18.06.2015
In April 2014, the European Parliament overwhelmingly passed a new regulation governing clinical trials, Regulation (EU) No 536/2015, repealing Directive 2001/20/EC following a transition period ...

EMA: Guideline on clinical investigation of medicinal products for the treatment of acute heart failure

18.06.2015
The current document is a revised version of this Addendum and the text has been updated in relation to certain factors. In particular, patient characteristics that impact on outcome of AHF trials ...

RAPS: BIO Calls for Increased Emphasis on Patient Perspectives by Biopharma, FDA

18.06.2015
Biopharmaceutical companies should seek out and incorporate the perspective of patients earlier on in the drug development process, a new white paper from the Biotechnology Industry Organization ...

GMP: Another Indian API Manufacturer found to be out of GMP Compliance by EU Authorities

18.06.2015
India continues to be the place were many manufacturing sites are found to be out of GMP compliance. This time it is the manufacturer POLYDRUG LABORATORIES PVT. LTD. , Plot No. 37, Anand Nagar, ...

EMA: Draft guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products

11.06.2015
This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor VIII products is made for use in ...

EMA: Draft guideline on core summary of product characteristics for human plasma derived and recombinant coagulation factor VIII products

11.06.2015
This guideline describes the information to be included in the summary of product characteristics (SmPC) for human plasma derived and recombinant coagulation factor VIII products, which are ...

EMA: Guideline on clinical investigation of recombinant and human plasma-derived factor IX products

11.06.2015
This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor IX products is made for use in treatment ...

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