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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, ...

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 ...

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 ...

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 ...

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 ...

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In June 2014, the FDA published a \"Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant ...

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 ...

GMP: Recommendations of the EMA for the risk assessment of metallic impurities in approved drugs

23.04.2015
Recently, with the inclusion of the Guideline ICH Q3D in the collection of \"Scientific Guidelines\", the EMA established the deadlines for its entry into force (see our news \"The CHMP adopts the ...

EMA: Draft qualification opinion of qualification of exacerbations of chronic pulmonary disease tool (EXACT), and EXACT-respiratory symptoms measure (E-RS) for evaluating treatment outcomes in clinical trials in chronic pulmonary disease

23.04.2015
The EXACT-PRO Initiative (EXAcerbations of Chronic Pulmonary Disease Tool – Patient-Reported Outcome) brought together clinical, research, methodology, and regulatory experts to develop a new ...