• Regulatory NewsRegulatory News

    German Regulator Says EMA's Clinical Trials Transparency Definitions are Too Broad

    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. German health technology assessment body IQWiG has criticized the European Medicines Agency's (EMA) clinical trials data transparency implementation plan, saying its definition of commercially confidential information is overly broad. In comments submitted to EMA, Beat...
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    India Proposes to Waive Phase III Trials for Drugs Approved in a 'Well-Regulated Country'

    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 Drugs Technical Advisory Board (DTAB) has recommended granting Phase III clinical trial waiver to some drugs approved in "well-regulated" countries like the US or EU. The waiver would also require drug sponsors to agree to implement a four-year post-marketing s...
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    China Adopts Milestone Device Good Supply Practices

    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. China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices. The GSP regulatio...
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    India Proposes New Requirements for Bioequivalence Studies

    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 India’s Central Drugs Standard Control Organization (CDSCO) is soliciting input on a draft guidance that establishes a uniform format for filing requests for the approval of bioequivalence studies that are to be conducted in India on drugs intended for export. The uni...
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    China Update: New Device GMPs and a World-First Vaccine Approval

    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. China Revises Device GMPs China’s Food and Drug Administration (CFDA) has issued revised current medical device good manufacturing practices (GMPs) that require manufacturers to implement quality management systems covering product design and development, manufacturing...
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    Indian Regulator Soliciting Feedback on Regulatory System Upgrade Plan

    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 Standards Control Organisation (CDSCO) is soliciting feedback on the Ministry of Health and Welfare's plan to upgrade the country’s regulatory system at both national and state levels over the next three years. The goal of the upgrade is to “faci...
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    India Seeks Input on Draft Revisions to Device GMPs

    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) is seeking input on draft revisions to Schedule M-III of the country’s Drug and Cosmetic Act , which describes good manufacturing practices (GMPs) for medical devices. The revisions aim to bring the GMP requi...
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    Indian Regulators Call for Comment on Revised Clinical Trial Standards

    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), the country's medicines regulator, is seeking input from the public on draft revised accreditation standards for clinical trials. The standards were prepared by the National Accreditation Board for Hospital...
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    Canada Launches Ebola Vaccine Trial

    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 Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC) have provided funding for a Phase I clinical trial using Canada’s Ebola vaccine (VSV-EBOV), Canada's Minister of Health, Rona Ambrose, announced last week.  The Canadian Im...
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    India’s CDSCO Reduces API Stability Testing Data Requirement

    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 22 October 2014 cutting the long term stability testing data requirement for active pharmaceutical ingredient (API) exports to the EU from 12 months to 6 months based on results from three ba...
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    Swiss Regulators Approve Ebola Vaccine Trial Meant to Protect Medical Volunteers

    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. Swiss healthcare product regulator Swissmedic has approved an application to start a clinical trial for an experimental Ebola vaccine at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, the regulator announced on 27 October 2014. Given the severity of ...
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    Australian Government Orders Review of Drug and Device 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. The Australian government has announced that experts will review the Therapeutic Goods Administration’s (TGA) framework for the regulation of medicines and medical devices. According to a 24 October 2014 announcement by Health Minister Peter Dutton and Assistant Minist...