• Feature ArticlesFeature Articles

    Bringing Structure to Substance Information

    This article discusses compliance challenges pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured substance information. To support continuous pharmacovigilance oversight improvement within the EU, the European Commission has mandated pharmaceutical companies’ adherence to ISO IDMP standards by 1 July 2016 . 1 These standards collectively outline the data ...
  • Regulatory NewsRegulatory News

    EMA Reflects on Advanced Therapy Classification

    The European Medicines Agency (EMA) has released a new reflection paper discussing how products are classified as advanced therapy medicinal products (ATMPs). Background In the EU, medicinal products derived from genes, cells or tissues are classified as ATMPs. Because these areas of biomedicine are still in early stages of development and are fundamentally different from other types of medicine, the European Commission (EC) regulates them differently. ATMPs are define...
  • Regulatory NewsRegulatory News

    EMA Releases Draft Guideline on Epidemiological Data Requirements for Plasma-Derived Products

    The European Medicines Agency (EMA) has released a draft Guideline on epidemiological data on blood transmissible infections intended to provide clarification on the data requirements for plasma-derived products. Background In the EU, companies must submit scientific data for blood- or plasma-derived medicinal products using the plasma master file (PMF) certification procedure. The requirement for PMF certification was established in Directive 2003/63/EC , which ...
  • Regulatory NewsRegulatory News

    EMA Adopts New Guideline on Urine-Derived Product Safety

    The European Medicines Agency (EMA) has adopted a new guideline on the regulatory requirements for ensuring the viral safety of urine-derived medicinal products. Background Human urine is an essential component in certain hormone-based treatments and some products used to break up blood clots. Products derived from human urine have been available in Europe since the 1970s. While numerous improvements have been made to ensure the safety and purity of these products, spe...
  • Regulatory NewsRegulatory News

    EMA Issues New Guideline on Gene Therapy

    The European Medicines Agency (EMA) is seeking feedback on a new draft guideline aimed at clarifying the scientific evidence necessary to support the authorization of new gene therapies. Background Gene therapy works by modifying a patient's genes to correct for genetic issues. Researchers have been studying gene therapy for the past 30 years, but few products have reached advanced stages of development. Because so few gene therapies have been submitted for authorizatio...
  • EMA to Publish Scientific Opinions on Medicines Contained in Medical Devices

    The European Medicines Agency (EMA) will for the first time begin publishing public assessment reports (PARs) for pharmaceutical and biological medicines used in medical devices, the agency said in an 8 August announcement . The EU regulatory agency does not, to the consternation of critics , review medical devices. Devices intended for marketing in Europe are instead regulated through the European Conformity (CE) marking system, through which devices are assessed by e...
  • Australia: TGA Issues Revised Medical Gases GMP Guidance

    Australia's Therapeutic Goods Administration (TGA) has issued guidance concerning the applicability of the 2009 Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co- operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products to the production of medicinal gases.  The new guidance replaces the TGA's earlier interpretation of the 2002 PIC/S GMP guidance. The revised interpretation was developed in cooperation with Australi...
  • EMA Releases Paper on Advanced Therapies to Assist Sponsors

    The European Medicines Agency (EMA) has released a new reflection paper on the classification of advanced-therapy medical products (ATMPs)-therapies made from genes and cells-which aims to clarify the legal basis for the classification of advanced therapies and provide information to applicants on how to submit applications for approval to EMA. In particular, the paper "provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tiss...
  • Feature ArticlesFeature Articles

    The French Act N°2011-2012: Boosting Safety or Creating a Storm?

    The scandal surrounding French adjuvant therapy in hypertriglyceridemia and overweight diabetics drug Médiator, and the many deaths apparently linked to the product directly led to enactment of  The French Act N°2011-2012   of 29 December 2011 by the National Assembly. The law, sponsored by France's Ministry of Labor, Employment and Health to restore public confidence and enhance the safety of medicinal and health products, affects all stakeholders ...
  • Draft Guideline Released on Assessing Risk of Advanced Therapy Medicinal Products in Europe

    The European Medicines Agency (EMA) released a new draft guideline on 24 January assessing Advanced Therapy Medicinal Products (ATMPs) using a risk-based approach. ATMPs are biological medicinal products such as gene therapy, somatic cell therapy or tissue-engineered products. According to EMA , ATMPs contain an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replac...