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    CDSCO Forms Task Force Focused on User-Friendly Reforms

    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 announced the formation of a new task force to undertake a comprehensive review of the existing processes, procedures, forms and licenses used by the agency with the purpose of making them simpler and more ...
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    Anvisa Updates BA, BE Test Best Practices Certification

    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. Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies.  The practices are those that must be adopted by research centers in order to ensure their BA/BE studies—comparing pharma...
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    European Commission Issues Final Opinion on Metal-on-Metal Hip Implants

    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 European Commission’s Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) issued on 9 October 2014 its final opinion regarding the safety of Metal-on-Metal (MoM) joint replacements, and hip implants in particular. SCENIHR's report concludes th...
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    India Proposes Ban on Certain Plastic Drug Containers

    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 proposed   to ban Polyethylene Terephthalate (PET) or plastic containers in primary packaging for liquid oral drug formulations for pediatric use, geriatric use and for use in pregnant women and women of rep...
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    Anvisa Demonstrates New Drug Tracking Platform

    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. Anvisa has unveiled Brazil's first drug tracking platform - a step in the implementation of the National Drug Control System (SNCM) - providing an interface between the agency and the holders of drug registrations. The system was demonstrated on 8 October 2014 on the pr...
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    Australia’s TGA Launches Web-based ADR Reporting

    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 launched a web-based medicines and vaccine related adverse event (adverse drug reaction, or ADR) reporting system for the use of consumers. The new web-based reporting service is one of a range of TGA initiative...
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    Anvisa Launches Drug and Device Monitoring Program

    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. Brazilian regulator Anvisa has launched two programs for monitoring the quality of medicines and health products in Brazil.  The National Program for Quality Control of Medicines (Proveme) will initially analyze monthly samples of drugs from Aqui Tem Farmácia Popula...
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    NICE Urges Review of Drug Evaluation Methodology

    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. Following public criticism of its rejection of a number of expensive cancer treatments, the UK’s health cost watchdog is calling for a review of the way new medicines are adopted by the National Health Service.  In a statement released today, the National Institute for ...
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    Australia’s TGA Issues Amended Nonclinical Studies 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. Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued  an amended guidance on nonclinical studies for Module 4 of the  Common Technical Document  (CTD), which is an integral part of an application to register a prescription medicine on...
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    Australian Regulator TGA Undergoing Reorganization

    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 (11 September) an internal reorganization as part of broader structural changes within the Department of Health following the Finance Ministry’s call for a " smaller and more rational " government. The D...
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    India’s CDSCO Establishes New Clinical Trial Application Requirements

    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 an order on 5 September 2014 with “immediate effect” that all applications for the approval of global and new clinical trials must now include the following information: An assessment as to the risks...
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    Australia’s TGA Clarifies Drug Approval Process in New Document

    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) this week issued a new question and answer (Q&A) guidance  concerning the registration process for new prescription drugs, as well as how to make changes to an already registered product that involves clinical, nonclin...