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URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 4, 2015 on the accession the Voluntary Harmonization Procedure (VHP) in clinical trials.

12.03.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 4, 2015 on the accession the Voluntary ...

FDA: Complicated Urinary Tract Infections: Developing Drugs for Treatment, Guidance for Industry

05.03.2015
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). Specifically, this guidance addresses the ...

RAPS: FDA to Study Quality of Long-Acting Generic Drug Products, Including Popular Birth Control Drug

05.03.2015
The US Food and Drug Administration (FDA) is prepared to spend nearly a million dollars over the next two years to study the quality and effectiveness of long-acting generic drug products, ...

RAPS: Asia Regulatory Roundup: India\'s CDSCO May Soon Regulate Devices (18 February 2015)

05.03.2015
CDSCO Readies to Take Control of Medical Devices as Pricing Row Escalates The Central Drugs Standard Control Organization (CDSCO) will gain oversight of medical devices if a proposed legislative ...

GMP: Requirements for Risk Analyses in the Regulatory Submission Dossier: EMA\'s and FDA\'s Recommendations

05.03.2015
The EMA has published a new question & answer-(Q&A) paper together with the FDA at the end of 2014. This document answers questions on detailed requirements in connection with the documents ...

GMP: Supply Chain: A Series of new Regulations in Force

05.03.2015
The new EU Directive 2011/62/EU and its delegated acts keep on changing the pharmaceutical supply chain. The directive introduced numerous Delegated Acts with different time schedules and had some ...

GMP: GMP Data Integrity: New MHRA Guideline

05.03.2015
The MHRA announced in January 2014 that the pharmaceutical industry is expected to review data integrity within the frame of self inspections. Now, a Guideline of the MHRA on data integrity was ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 10, 2015 concerning reporting adverse reactions to medicinal products

26.02.2015
This document is an information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 10, 2015 concerning reporting adverse reactions ...

GMP: EU GMP Annex 1: EMA plans the Revision of the Sterile Guide

26.02.2015
At the beginning of February 2015, the European Medicines Agency (EMA) published a Concept Paper on the revision of Annex 1. Annex 1 of the EU GMP Guide is the Guideline for Europe which describes ...

GMP: EU issues new Version of GMP Guide Chapters 3 and 5

26.02.2015
The EU has re-published the recently revised Chapter 3 and Chapter 5 and has made modifications regarding the transition period for the introduction of toxicological evaluations of products in ...

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