Search Results for EMA guidance

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European Regulatory Roundup: EMA Offers Guidance on Assessing Periodic Safety Update Reports (13 April 2017) By Nick Paul Taylor - Published 13 April 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: EpiPens, House of Lords, drug pricing, EMA guidance

EMA Releases Q&A on Exposure Limits and Hazardous Compounds By Zachary Brennan - Published 09 January 2017

The European Medicines Agency (EMA) on Monday released for public consultation a new question and answer document focused on the risk-based prevention of cross contamination in pharmaceutical manufacturing and setting health-based exposure limits for risk identification.

Categories: News, Europe, EMA, Drugs, Preclinical

Tags: hazardous drug compounds, EMA guidance, HBELs

EMA to Revise Herbal Medicines Guideline By Zachary Brennan - Published 01 September 2016

The European Medicines Agency (EMA) on Thursday opened for public comment a draft revision to its scientific guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicines.

Categories: News, Europe, EMA, Nutritional and dietary supplements

Tags: herbal medicine, EMA guidance

Cystic Fibrosis: EMA Considers Revisions to Guidance for Developing New Drugs By Zachary Brennan - Published 01 August 2016

As the knowledge of the genetic principles and other recent developments in the field of cystic fibrosis (CF) has provided more insight into the pathophysiology of the disease, the European Medicines Agency (EMA) on Monday announced its intention to update certain outdated elements in its guidance.

Categories: News, Europe, EMA, Drugs, Due Diligence, Government affairs, Research and development

Tags: EMA guidance, CF, cystic fibrosis, CFTR

EMA Offers First Guidance Devoted Entirely to PBPK Modelling By Zachary Brennan - Published 29 July 2016

The European Medicines Agency (EMA) on Friday unveiled its first-ever draft guideline focused on the use of physiologically-based pharmacokinetic (PBPK) modelling.

Categories: News, Europe, EMA, Preclinical, Regulatory intelligence, Regulatory strategy, Research and development

Tags: PBPK modelling, EMA guidance, MAA dossier

Genomic Data and Drug Development: EMA Offers New Draft Guidance By Zachary Brennan - Published 02 May 2016

As the push for personalized medicine garners more attention, the European Medicines Agency (EMA) on Monday released new draft guidance to provide industry with more insight on how to identify and understand genomic factors that influence drug responses.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Crisis management, Government affairs, Quality

Tags: pharmacogenomics, liquid biopsy, cancer drugs and genomics, EMA guidance

EMA Offers Updated Draft Guidance on Human Clinical Trials for Cancer Drugs By Zachary Brennan - Published 16 March 2016

The European Medicines Agency (EMA) on Tuesday published new draft guidance on the evaluation of anticancer medicines in humans that covers all stages of clinical development.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Research and development

Tags: oncology clinical guidance, EMA guidance on oncology trials, cancer clinical trials

EMA Offers New Draft Guidance on Developing Treatments for Chronic Heart Failure By Zachary Brennan - Published 11 February 2016

The European Medicines Agency (EMA) on Thursday released new draft guidance for public consultation on the clinical development of new drugs to treat chronic heart failure (CHF).

Categories: News, Europe, EMA, Clinical, Drugs, Due Diligence, Government affairs, Preclinical, Research and development

Tags: chronic heart failure, heart failure treatments, heart failure hospitalization, EMA guidance