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  • Regulatory NewsRegulatory News
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    The Essential List of Regulatory Authorities in Asia

    To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.   For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unc...
  • Regulatory NewsRegulatory News

    EMA Highlights Central Nervous System Drug Development Challenges

    The European Medicines Agency (EMA) on Tuesday published an analysis highlighting the complexity of developing treatments for central nervous system (CNS) disorders, such as Alzheimer's disease, epilepsy and schizophrenia. "Research into medicines for CNS is complex, with a higher rate of failure during the clinical development of these products compared to other fields of medicine," EMA says. To conduct its analysis, EMA says its staff members reviewed a total of 103 a...
  • India Takes Inspiration From FDA, EMA in Bid to Improve CDSCO

    India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), might receive a major overhaul and a new name if a proposal by the Ministry of Health is enacted, Bloomberg TV India reports. Challenges at CDSCO While India has developed into a pharmaceuticals powerhouse, its regulator has struggled to keep up with the growth of its pharmaceutical industry. In 2012, a report commissioned by an Indian parliamentary committee found CDSCO struggled with...
  • Feature ArticlesFeature Articles

    Out of Africa: Six Regulatory Articles that Span the Continent

    Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...
  • Regulatory NewsRegulatory News

    NIH Calls for Changes to Federal Research Oversight Policies

    The National Institutes of Health (NIH) is trying to simplify the oversight of complex, multi-center clinical trials through a new policy promoting the use of a single institutional review board in trials it oversees. Institutional review boards (IRB), sometimes known as ethics committees in foreign countries, are meant to ensure that clinical trial participants are treated safely and fairly in accordance with local, national and international regulations. Traditionally...
  • Regulatory NewsRegulatory News

    Report Finds FDA Slow to Approve CNS Drugs, But Getting Faster

    A new report published by the Tufts Center for the Study of Drug Development (CSDD) validates longstanding data indicating that drugs intended to treat disorders of Central Nervous System (CNS) take longer to develop and are rejected by US Food and Drug Administration (FDA) regulators at a higher rate than are other drugs. Background Disorders of the central nervous system are as diverse as they are challenging to treat. Some of the most common CNS disorders include dep...