Aktualności
EMA: Clinical Trial Regulation
30.04.2015
The Clinical Trial Regulation aims to create an environment that is favourable to conducting clinical trials in the European Union (EU), with the highest standards of safety for participants. On
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EMA: Preventing medication errors in the European Union
30.04.2015
The European Medicines Agency (EMA), on behalf of the European Union (EU) Regulatory Network, has released two draft good practice guides that aim to improve the reporting, evaluation and
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GMP: Counterfeiting in Reimport of Viread in the legal Supply Chain
30.04.2015
Counterfeit medicines in the legal supply chain are increasingly becoming a problem. Experts are sure that counterfeiters will try more and more to sell fake medicines not only via the Internet,
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RAPS: FDA Finalizes Lot Distribution Report Guidance With Few Changes
30.04.2015
New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify how biopharmaceutical companies should submit so-called \"lot distribution reports\" (LDRs)—reports
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EMA: Codeine not to be used in children below 12 years for cough and cold
30.04.2015
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1 has agreed by consensus new measures to minimise the risk of serious side effects, including breathing
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 21, 2015 concerning additions to the publishing EDQM Standard Terms and Almanac (special issue of July 2007)
30.04.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 21, 2015 concerning additions to the publishing EDQM
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 27, 2015 concerning position of Coordination Group for the Mutual Recognition and Decentralised concerning the introduction
30.04.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 27, 2015 concerning position of Coordination Group
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URPL: Communication to the Healthcare Professional for changes in the use of the medicinal product Mucofluid in children and adolescents
30.04.2015
Communication to the Healthcare Professional for changes in the use of the medicinal product Mucofluid in children and adolescents. ...
GMP: FDA finalizes Guidance on Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products
23.04.2015
In June 2014, the FDA published a \"Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant
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GMP: Guideline to Register as a Broker of Medicinal Products
23.04.2015
All Stakeholders dealing with Medicinal Products need to be registered and have to comply with GDP requirements. According to the definition a broker is involved in independently selling or
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