• European Regulators Issue 'Major Revision' to Guideline on Investigating Drug Interactions

    The European Medicines Agency (EMA) on Friday, 6 June issued an updated guideline on the investigation of drug-drug interactions, giving the guidance its first "major revision" since 1998. The guidance addresses the "potential for pharmacokinetic interactions between new medicinal products and already marketed drugs" and other products-including food-and how to best address drug-drug interactions (DDI) through in vitro and in vivo studies. DDIs are commonly associate...
  • New EMA Guideline on Diabetes Focuses on Cardiovascular Risks

    The European Medicines Agency (EMA) has released a new guideline aimed at assisting sponsors in the development of products to treat or prevent diabetes mellitus. The guideline makes important changes to how the agency plans to assess the cardiovascular risk of diabetes products and its "high-level" approach to emerging diabetes products. The new guideline, On Clinical Investigation of Medicinal Products in the Treatment or Prevention of Diabetes Mellitus , updates a pr...
  • EMA Finalizes Pharmacovigilance Practice Guidelines

    The European Medicines Agency (EMA) has released seven new guideline modules outlining good pharmacovigilance practices (GVPs) to assist sponsors with complying with the soon-to-be-implemented pharmacovigilance (PV) legislation, which comes into effect 2 July 2012. The modules cover a variety of topics, including PV systems, PV quality systems, risk management systems, PV system master files, Periodic safety update reports (PSURs), postmarketing safety studies and advers...
  • ICH Publishes New Guideline on Clinical Study Reports

    The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released a new question and answer document for its E3: Structure and Content of Clinical Study Reports ("The E3 Guideline") guideline. Writing on 21 June 2012, ICH said the document was finalized in mid-June as part of Step 4 of its Q&A Procedure process, indicating the document has reached consensus status and is in the proces...
  • European Regulators Want New Gout Guidelines

    The European Medicines Agency (EMA) on Thursday released a new concept paper calling for new guideline to assist sponsors conducting clinical trials on medicinal products intended to treat gout. Gout, an inflammatory arthritis brought on by the introduction of monosodium urate crystals within a patient's joints and tissues, is currently estimated to affect 3.9% of adults, with nearly three times as many men being affected as women. In its 14 June concept paper, EMA note...
  • EMA Releases First Revision to Biosimilar Quality Guidelines Since 2006

    The European Medicines Agency (EMA) announced it has released a newly-revised guideline on the quality of biosimilar medicines and is soliciting comments. The 31 May 2012 guidance, Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues , updates a previous guidance released in 2006. Biosimilar medicines are ones similar to branded biologics pioneered by previous companies. Due to the inherent comp...
  • EMA Releases New Draft Guideline on Ensuring the Quality of Animal-based Biotechnology

    The European Medicines Agency (EMA) released a new draft guideline for sponsors obtaining biologically active substances from transgenic animals on 31 May, saying new guidance was necessary to help manufacturers achieve quality measures when using the biotechnology. EMA explained the proposed guidance adheres to many of the same specific aspects of quality guidance already in place for other recombinant production systems. "As is the case with other biotechnologically ...
  • ICH Looking to Establish New Harmonized Guideline on Carcinogenicity Testing

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced 14 May it has established a concept paper and business paper for a new expert working group (EWG) aiming to develop guidance on rodent carcinogenicity testing. "The aim of this new topic is to introduce a more comprehensive and integrated approach to addressing the risk of human carcinogenicity of pharmaceuticals, and also to clar...
  • ICH Releases Update for E14 Guideline on Clinical Evaluation of Non-Antiarrhythmic Drugs

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released an updated version of its Efficacy (E) 14 Guideline, providing four new pieces of insight on the clinical evaluation of non-antiarrhythmic drugs. ICH's Q&A document for E14 - The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs was originally released under Step 4 o...
  • New EMA Guideline on Real Time Release Testing

    The European Medicines Agency (EMA) released a final guideline on real time release testing (RTRT), aiming to provide better guidance for regulatory professionals to ensure their products consistently meet necessary specifications. "RTRT is a system of release that gives assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control," explained EMA ...
  • EMA Releases Draft Guideline on Process Validation

    The European Medicines Agency (EMA) has released a new draft guideline on process validation that brings EMA thinking in line with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q8, Q9 and Q10 documents on continuous process validation. Process validation, which EMA defines as "documented evidence that the process, operated within established parameters, can perform effectively and repr...
  • EMA Releases Guideline on Pharmacovigilance Plan Submissions

    The European Medicines Agency (EMA) released guidance 29 February on how Marketing Authorization Holders (MAH) can submit pharmacovigilance (PhV) systems as part of their Marketing Authorization Application . The plans are used to detect, understand, prevent or otherwise minimize adverse events occurring as the result of medicinal products. "This document provides clarification and further explanation of the requirements for a detailed description of the PhV system (DD...