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EMA: Regulatory information – Updated SME user guide now available

20.10.2016
The European Medicines Agency (EMA) has updated its user guide for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. The guide aims to support SMEs to better ...

GMP: What are the GMP Responsibilities of the Marketing Authorisation Holders?

20.10.2016
The GMP/GDP Inspectors Working Group of the European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH). It is ...

EMA: Concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, blue tongue and foot and mouth disease

29.09.2016
The Immunologicals Working Party recommends to review, and possibly revise, the Committee for Medicinal Products for Veterinary Use ‘Guideline on data requirements for multi-strain dossiers for ...

EMA: Concept paper for the revision of the note for guidance on the use of adjuvanted veterinary vaccines

29.09.2016
The Immunologicals Working Party (IWP) recommends revisiting the contents and replacing the note for guidance on the use of adjuvanted veterinary vaccines with a new guideline, to take into ...

FDA: Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease

29.09.2016
This guidance provides a qualified context of use (COU) for the biomarker plasma fibrinogen, in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high ...

FDA: Self-Identification of Generic Drug Facilities, Sites, and Organizations

29.09.2016
This guidance is intended to assist human generic drug facilities, sites, and organizations by describing how to comply with the self-identification requirement contained in the Generic Drug User ...

GMP: FDA Guidance on Determining Donor Eligibility for Autologous Donors of Blood and Blood Components

29.09.2016
In August 2016, the FDA published a guidance for immediate implementation on Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - ...

GMP: GVP Update

29.09.2016
On 8 August 2016, draft revision 2 of Module VI on management and reporting of adverse reactions and draft revision 1 (major revision) of Module IX on signal management with its Addendum I ...

GMP: FDA´s New Regulations for Drug Manufacturers

29.09.2016
The US Food and Drug Administration (FDA) amends its requirements for foreign and domestic establishment registration and listing for human drugs, including drugs that are regulated under a ...

URPL: Information of General Director of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 23, 2016 on the procedures for the access to the file of proceedings.

08.09.2016
This document is announcement of General Director of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 23, 2016 on the procedures for the access to ...