News
EMA: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
09.10.2014
Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of
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EMA: Guidebook for tenderers: Submitting a tender in response to a procurement procedure organised by European Medicines Agency
02.10.2014
This document is designed to help tenderers to submit their tenders in response to procurement procedures issued by the Agency for the supply of goods and services and also for works. ...
EMA: Patients to discuss benefit-risk evaluation of medicines with the Committee for Medicinal Products for Human Use
02.10.2014
The European Medicines Agency (EMA) has launched a pilot project to involve patients in the assessment of the benefits and risks of medicines in its Committee for Medicinal Products for Human Use
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EMA: Guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome
02.10.2014
This guideline intends to address the EU regulatory position in the main topics of clinical development of new medicinal products in the treatment of patients with Irritable Bowel Syndrome (IBS).
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GMP: New Guideline for Recall of IMPs
02.10.2014
The European Commission DG Health & Consumers has published the new EU-GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely. ...
EMA: Draft guideline on core summary of product characteristics for human plasma-derived and recombinant coagulation factor-IX products
02.10.2014
This guideline describes the information to be included in the summary of product characteristics (SmPC) for human plasma-derived and recombinant coagulation factor-IX products, which are
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EMA: Policy on veterinary medicines for minor use, minor species / limited market revised
25.09.2014
The European Medicines Agency has revised the operation of its minor-use-minor-species (MUMS) / limited-market policy for veterinary medicines to direct its assistance to those medicines most
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EMA: Guideline on bioanalytical method validation
25.09.2014
This guideline defines key elements necessary for the validation of bioanalytical methods. The guideline focuses on the validation of the bioanalytical methods generating quantitative
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EMA: Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with revision 1 of module III on pharmacovigilance inspections and of module VI on the management and reporting of adverse reactions reports
25.09.2014
This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product or Population-Specific Considerations. ...
EMA: Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products
25.09.2014
This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and chapter 3 of Regulation (EC) No726/2004 [REG], which are applicable to competent
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