• Regulatory NewsRegulatory News

    Brazilian Device Industry Prepares for eSubmissions

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil's medical device industry should prepare for electronic submissions, Anvisa, Brazil's national regulatory agency, said at a 20 August 2014 meeting . The meeting provided an opportunity for the agency to discuss its implementation strategy for the International ...
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    Australia’s TGA Proposes Major Update of 2001 Labeling Regulations

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) is seeking comments on multiple proposals for the first major revision of its 2001 Drug Labeling Regulations. The regulations are intended to address safety risks posed by issues such as: The difficulty of finding ...
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    Anvisa to Develop Standards and Guidelines for Nanotechnology Products

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil’s national regulatory agency, Anvisa, has established a multidisciplinary Nanotechnology Committee within the agency with the mandate to develop standards and specific guidelines for the evaluation and regulation of products that use nanotechnology.  In additio...
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    Australia’s TGA Opens Review of All Surgical Mesh Devices

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) has announced that it will initiate the reassessment of the clinical evidence for all urogynecological surgical mesh implants to determine if they comply with the requirements for safety and performance necessary for ma...
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    Brazilian Regulator Anvisa Issues New Track and Trace Guidance

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil’s national regulatory agency, Anvisa, has published guidance on the implementation of the country's track and trace system for drugs, the National Drug Control System (SNCM).  The guidance manual , released 18 August 2014, specifies the requirements for mandator...
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    India’s CDCSO Establishes New Testing Requirements for Blood Glucose Strips

    India’s Central Drugs Standard Control Organization (CDSCO) is looking to tighten the regulation of blood glucose testing supplies, it announced last week. In a 7 August 2014 notice issued to all local State Drugs Controllers and port authorities, CDSCO ordered that importers and manufacturers of blood glucose test strips and analyzer based glucose reagents must provide three batches for testing at the National Institute of Biologicals in Noida.  Following the testin...
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    Brazilian Regulators Propose Amendments to Country's Clinical Trial Rules

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil’s national regulatory agency, Anvisa, announced on 4 August 2014 that it has opened consultations on two separate proposed regulations that would amend existing procedures governing clinical trials with both drugs and medical devices. The first, CP 64, targets medica...
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    India’s CDSCO Issues Guidance on How to Conduct GMP Inspections

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on 6 August 2014 to all local State Drugs Controllers setting forth uniform procedures on how to conduct good manufacturing practice (GMP) inspections of local pharmaceutical manufacturing facilities....
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    UK's NICE Rejects Roche's Breast Cancer Drug Kadcyla, Citing Major Cost Concerns

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance confirming its earlier rejection of Roche’s breast cancer drug treatment Kadcyla for National Health Service (NHS) coverage. Kadcyla (trastuzumab emtansine) treats women with m...
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    India Proposes eSubmission Process for Clinical Trials

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) has published a proposal to create an information technology (IT) system that would permit the online submission of information on clinical trials by sponsors, clinical research organizations (CROs), investigators, e...
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    Ireland Considers Switching 12 Medicines to OTC Status

    Ireland's Health Products Regulatory Authority (HPRA) has published a list of twelve active ingredients (or combinations of ingredients) that are currently classified as prescription-only medicines (POM) which it believes could safely be made available to consumers over-the-counter (OTC). There are currently 34 drugs approved in Ireland that contain one of the ingredients included on the list, including medicines for the treatment of migraine, acid reflux, hay fever, ...
  • Spain Launches new Registry of API Manufacturers, Distributors, Importers

    The Spanish Agency for Medicines and Health Products (AEMPS) has launched a registry of businesses involved in the manufacture, import and distribution of pharmaceutical active ingredients in Spain. The Unified Public Business Registry of Active Substance Businesses (RUESA) is part of the transposition of Directive 2011/62/EU , which addresses counterfeit drugs in the European Union and includes additional controls for active ingredients. The aim of the RUESA is to s...