• India Issues Draft Drug GDP Guidance

    India's Central Drug Standards Control Organization (CDSCO) released on 10 January 2013  draft guidelines  on good distribution practices (GDP) for pharmaceutical products intended to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. Elements of the process include, but are not limited to, procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices.  The...
  • Feature ArticlesFeature Articles

    GCP Convergence Improves Transportability of Medical Device Clinical Data

    • 10 January 2013
    The safety, performance and effectiveness of medical devices are often evaluated by well-controlled clinical investigations before marketing authorization. The integrity of these clinical studies is ensured by compliance with voluntary standards or government regulations known as Good Clinical Practices (GCPs). Four GCPs are most applicable to US and Japanese marketing approvals: US Food and Drug Administration (FDA) regulations and guidance, Japanese GCP ordinances and n...
  • Brazil Clarifies Informed Consent Requirements

    Brazil's National Health Surveillance Agency, Anvisa, has released a notice clarifying the rights of individuals who participate as clinical research subjects in the country. The notice specifies that clinical trial subjects must be informed that Brazilian law prohibits compensation for participating in a trial with the exception of being reimbursed for the cost of transportation and meals. The notice also states that a clinical trial subject has the right to lea...
  • Indian Regulators Finalize Recall System Requirements

    Just weeks after releasing draft guidelines on a new recall system, India's Central Drugs Standard Control Organization (CDSCO) has finalized its recall and rapid alert system for chemical and biological drugs, bringing the country much more closely in line with the recall standards of most established regulatory authorities. The draft guideline , released in late October, was available for public comment for 15 days. A side-by-side analysis of the draft and final guide...
  • EMA Releases Draft Guideline on Hepatitis B Vaccines

    The European Medicines Agency (EMA) has released a new guideline to instruct sponsors of clinical trials on best practices for assessing antibody-based products used to prevent the hepatitis B virus. The 2 December 2012 draft guideline, On the Clinical Investigation of Hepatitis B Immunoglobulins , is specifically aimed at vaccines, which EMA explains are an effective method for protecting uninfected, healthy individuals against infection by the hepatitis B virus. T...
  • Revisions to Osteoporosis Guideline Called for by EMA

    The European Medicines Agency (EMA) has released a new concept paper calling for revisions to the way osteoporosis products are evaluated in the EU, saying existing guidelines are largely inadequate to assess a secondary form of the disease. The problem, explained EMA, is that current osteoporosis guidelines only cover primary osteoporosis, and do not address the evaluation of products used to treat secondary osteoporosis, often brought on by glucocorticoid therapy. Gl...
  • India's CDSCO Releases Proposed Changes to Recall System with Focus on Timelines

    India's Central Drugs Standard Control Organisation (CDSCO) has released a new draft guideline on a new recall and rapid alert system for chemical and biological drug products , bringing it more closely into line with the recall system used by US regulators. The intent of the rapid alert system is to place special emphasis on urgent recalls with the potential to seriously affect patients or the consuming entity (in the case of veterinary products, animals). These alerts...
  • India's CDSCO Finalizes Guideline on Good Distribution Practices for Biologicals

    India's Central Drug Standards Control Organization (CDSCO) has finalized and released a new guideline on good distribution practices for biological products manufactured in the country. Regulators said the guideline , originally released in late September 2012 in draft form , is intended to, "Assist in ensuring the quality and identity of biological products during all aspects of the distribution process."  Guidelines on Good Distribution Practices for Biologic...
  • EMA Releases Draft Guideline on Acute Heart Failure Therapies

    The European Medicines Agency (EMA) has released a new draft guideline detailing what information it expects of sponsors developing new therapies to treat acute heart failure (AHF). The guideline , released 15 October, is intended to fill in gaps in its chronic heart failure guidance, explained EMA. AHF is composed of what EMA refers to as a "wide spectrum of symptoms and signs, accompanied by hemodynamic abnormalities and neuroendocrine activation that arise secondary...
  • Multiple Sclerosis Guideline Calls for Adaptive Approaches Based on Risk

    The European Medicines Agency (EMA) has released a draft guideline for the clinical investigation of products intended to treat multiple sclerosis (MS), a neurological disease characterized by the body attacking its own fatty myelin sheaths, disrupting and damaging the body's ability to communicate with itself. The guideline -similar in principle to most released by EMA-establishes a set of recommended approaches to clinical development, with a particular focus on study...
  • New EMA Guideline Establishes Standards for Development of Antipsychotic Therapies

    The European Medicines Agency (EMA) is out with a new guideline on conducting clinical trials for products intended to treat schizophrenia which it says addresses a number of specific issues, including study design, use in sub-populations and use of add-on and combination therapies. Schizophrenia is a highly varied psychiatric disease that EMA notes is characterized by a "heterogeneous course and symptom profile." Approximately 1% of the population is affected over the c...
  • After Failures, EMA Calls for Overhaul of Existing Obesity Treatment Guidance

    A new concept paper released by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) seeks to establish an updated framework for anti-obesity and weight control drug products. In its 1 October concept paper, " Concept paper on the need for revision of the guideline of medical products used in weight control ," CHMP looks to a November 2007 guideline on weight control, noting that two weight control products have been pulled from the marke...