Search Results for guideline

Showing 1 – 25  of 58

EMA Offers Draft Guideline on Serious Breaches of Clinical Trial Regulations By Zachary Brennan - Published 23 May 2017

The European Medicines Agency (EMA) on Tuesday opened for public consultation a new guideline on serious breaches of clinical trial regulations or clinical trial protocols.

Categories: News, Europe, EMA, Clinical, Compliance, Government affairs, Research and development

Tags: clinical trial regulations, EMA guideline

EMA Offers Draft Guideline on Trial Master Files By Zachary Brennan - Published 13 April 2017

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the sponsor and member state inspections.

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

Tags: trial master file, EMA guideline

IMDRF Offers New Guideline on Adverse Event Reporting By Zachary Brennan - Published 10 April 2017

As a way to improve the accuracy and capture of medical device adverse events, the International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, on Monday published a new final guideline on a harmonized terminology for reporting such events.

Categories: News, Asia, Canada, Europe, US, IMDRF, Compliance, In vitro diagnostics, Medical Devices, Postmarket surveillance, Quality

Tags: adverse events for medical devices, IMDRF guideline, GHTF

European Regulatory Roundup: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017) By Nick Paul Taylor - Published 06 April 2017

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Government affairs

Tags: EU clinical trials, trial endpoints, EMA guideline

European Regulatory Roundup: EMA to Revise Guideline on Quality of Inhaled Medical Products (30 March 2017) By Nick Paul Taylor - Published 30 March 2017

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Regulatory intelligence, Submission and registration

Tags: EMA guideline, antibiotics, animal health

EC Unveils Revised Guideline on Pharmaceutical Excipients By Zachary Brennan - Published 28 February 2017

The European Commission on Tuesday opened for public comment a revised guideline concerning the list of excipients, defined as any constituents of a medicinal product other than the active substance and the packaging material, which must be included on the labeling of medicines, as well as the way in which these excipients must be indicated. 

Categories: News, US, EC, EMA, Compliance, Drugs, Quality

Tags: excipients, excipient guideline, European Commission guidance

EMA Revises Guideline on First-in-Human Trials By Zachary Brennan - Published 15 November 2016

The European Medicines Agency (EMA), in cooperation with the European Commission and the EU member states, on Tuesday proposed revisions to its 2007 guideline on first-in-human clinical trials as part of an effort to further improve the safety of participants as trial protocols become increasingly complex.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Quality, Regulatory intelligence, Regulatory strategy

Tags: first in human trials, clinical trial guidance, EU clinical trials, Bial, clinical trial guideline

Amended ICH GCP Guideline Addresses Evolution of Trials Landscape By Zachary Brennan - Published 29 September 2015

The International Conference on Harmonization (ICH) has amended its good clinical practice (GCP) guideline with the aim of helping industry address the increasing scale, complexity and cost of clinical trials.

Categories: News, Canada, Europe, US, ICH, Clinical, Compliance, Drugs, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: ICH, clinical trials guidelines, GCP guideline, clinical trial quality

EMA Updates its Biosimilar Insulin Guideline By Michael Mezher - Published 12 March 2015

The European Medicines Agency (EMA) has updated its guideline on the requirements for clinical and non-clinical development of biosimilar insulin products. The update expands the scope of the original document and gives additional detail on study design parameters.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Preclinical, Quality, Regulatory strategy, Research and development, Submission and registration

Tags: Biosimilars, guideline, human insulin

EMA Finalizes Major Guideline on Biosimilars By Alexander Gaffney, RAC - Published 29 October 2014

The European Medicines Agency (EMA) has finalized a long-awaited guideline containing new recommendations on how to bring "similar biological medicinal products"—also known as biosimilars—to market in the EU.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Preclinical, Submission and registration

Tags: Biosimilars, Guideline, Biosimilarity, Stepwise Approach, Biosimilar Bridging Data

EMA, FDA Team Up to Propose Guideline on Pediatric Gaucher Disease By Alexander Gaffney, RAC - Published 15 May 2014

US and EU regulators have come together to release an unusual joint proposal that they say will help speed up the development of new treatments affecting pediatric patients with Gaucher disease.

Categories: Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: EMA, EU, Gaucher Disease, Gaucher's Disease, Guideline, Clinical Trials, Pediatric, Paediatric

EMA Issues New Guideline on Controlling Disease Transmission Risks in Urine-Based Products By Alexander Gaffney, RF News Editor - Published 26 November 2013

Categories: EMA

Tags: Urine, Draft Guideline, Latest News, EU

EMA Updates Biosimilar Guideline to Account for Nuanced Development Approach By Alexander Gaffney, RF News Editor - Published 10 June 2013

Categories: EMA, Clinical

Tags: Non-Clinical, Revised Guideline, Latest News, biosimilar, guideline, EU

EMA Releases New Guideline Meant to Clarify Process for Naming Drug Products By Alexander Gaffney, RF News Editor - Published 07 June 2013

Categories: EMA

Tags: INN, Drug Name, Naming, Name, Latest News, guideline, EU

New EMA Guideline on Depression Focused on Special Populations By Alexander Gaffney, RF News Editor - Published 31 May 2013

Categories: EMA

Tags: guideline, EU

EMA Looks to Cut Down on Antibiotic Resistance through New Efficacy Guidelines By Alexander Gaffney, RF News Editor - Published 29 May 2013

Categories: EMA

Tags: Antimicrobial, antibiotics, Draft Guideline, Latest News, guideline, EU

New EMA Guideline Establishes Framework for Biosimilars, Use of International Comparator Studies By Alexander Gaffney, RF News Editor - Published 02 May 2013

Categories: EMA

Tags: Biosimilarity, Draft Guideline, Latest News, follow-on biologic, biologic, biosimilar, EU

EMA Publishes New Lupus Guideline Intended to Spur Development of New Therapies By Alexander Gaffney, RF News Editor - Published 06 March 2013

Categories: EMA

Tags: Lupus, Clinical Research, Draft Guideline, Latest News, clinical trials

EMA Regulators Release ICH Guideline on Genotoxic, Carcinogenic Starting Materials By Alexander Gaffney, RF News Editor - Published 25 February 2013

Categories: ICH, Manufacturing

Tags: Carcinogenic, M7 Guideline

ICH Manufacturing Impurities Guideline Goes to FDA, EMA, MHLW for Consideration By Alexander Gaffney, RF News Editor - Published 07 February 2013

Categories: ICH, Manufacturing

Tags: M7 Guideline

EMA Releases Draft Guideline on Biosimilar Heparin Products By Alexander Gaffney, RF News Editor - Published 01 February 2013

Categories: EMA

Tags: Heparin, biosimilar, guideline

UK's NICE Releases Draft Guidance on Diagnosis and Treatment of Hepatitis B By Louise Zornoza, RegLink - Published 18 January 2013

Categories: Regulatory Update, NICE

Tags: Draft Guideline, NHS, Hepatitis B, guideline

NICE Draft Guidance Recommends Drugs Not Indicated for Familial Breast Cancer By Louise Zornoza, RegLink - Published 16 January 2013

Categories: NICE

Tags: GMC, Breast Cancer, Draft Guideline, Latest News, UK

India Issues Draft Drug GDP Guidance By Ansis Helmanis, RegLink - Published 14 January 2013

Categories: Regulatory Update, India, CDSCO, Distribution

Tags: Good Distribution Practices, GDP, Draft Guideline

EMA Releases Draft Guideline on Hepatitis B Vaccines By Alexander Gaffney, RF News Editor - Published 03 December 2012

Categories: EMA

Tags: Antibody, Vaccine, Latest News, Hepatitis B, guideline, virus