• Regulatory NewsRegulatory News

    With Eye on Improving Quality, Indian Regulator gets First ISO Certification

    India’s regulatory authority has announced that one of its offices has become the first in the country to become certified by the International Organization for Standardization (ISO). In a press release, the Central Drugs Standard Control Organization (CDSCO) said that its Ahmedabad office received ISO 9001:2008 certification for its quality management system (QMS) on 16 February 2015. Background ISO 9001 is a set of standards for QMS in organizations where it is imp...
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    ICH Takes Step Toward New eCTD Version

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced it has completed a step in the development of the next major version of the electronic Common Technical Document (eCTD). ICH’s M8 expert working group (EWG) has completed a draft of the implementation guide for ICH eCTD v4.0, the first major version change since v3.0 was adopted in 2003. Background ICH was formed followin...
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    FDA Adopts International Photosafety Testing Standard

    New guidance published by the US Food and Drug Administration (FDA) would bring the US into alignment with an international standard meant to ensure new drug products don't cause photosensitivity in patients. The standard, S10 – Photosafety Evaluation of Pharmaceuticals , was developed by the International Conference on Harmonisation (ICH), an international body composed of FDA, the European Medicines Agency (EMA), Japan's Pharmaceutical and Medical Device Agency (PMD...
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    Australian Regulator Hits Restart on Plan to Name Biosimilars

    Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has announced it will no longer implement a planned update to the way in which it names biosimilar products following a proposal by the World Health Organization to change a naming standard on which Australia relied for its policy. Background Under TGA's original proposal , biosimilars would have been referred to using their Australian Biological Name (ABN) followed by the prefix “sim(a),” whe...
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    EMA to Share Information About Generic Drugs With Other Regulators

    The European Medicines Agency (EMA) has announced it is ready to begin sharing its assessments of generic drugs as part of an ongoing pilot with participating regulatory authorities. The goal of the pilot program, known as the International Generic Drug Regulators Pilot (IGDRP), is to bolster collaboration with regulators around the world and address the challenge of assessing generic drug applications. Background In October 2011, regulatory authorities from Australia...
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    FDA, CDC Put $18M Behind Adverse Event System for Vaccines

    The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have awarded a new, $18 million contract meant to support its existing Vaccine Adverse Event Reporting System (VAERS) over the next five years. The award will go to Virginia-based SRA International, the company announced in a 17 November 2014 press release . SRA has supported FDA's VAERS program since 1999, it said. VAERS is used by FDA to collect and analyze reports of vacci...
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    Public Comment Period Opens on ISO 9001, Major Device Quality Standard

    The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation. Background The standard, which covers Quality Management Systems (QMS), undergoes  a revision process once every five years, and was last updated in 2008 (ISO 9001:2008). The ISO 9001 standard is used extensively throughout the medical...
  • FDA to Spend up to $10 Million Strengthening Regulation in South America

    • 17 July 2014
    US regulators are planning to work more closely with a global health group focused heavily on South America in the hopes of strengthening medical product regulatory systems across the region. In an announcement on 8 July 2013, the US Food and Drug Administration (FDA) said it plans to award the Pan American Health Organization (PAHO) a contract to help "foster regulatory collaboration and strengthen regulatory capacity throughout the Americas." Regulatory capacity broad...
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    US, EU Officials in Tangle Over Mutual Reliance on Drug Facility Inspections: Report

    US and EU trade negotiators are reportedly hung-up over how—or if—to rely on the results of one another's regulatory inspections of drug manufacturing facilities, threatening to derail part of the Trans-Atlantic Trade and Investment Partnership (TTIP), The Wall Street Journal reports . At issue, the Journal 's Matthew Dalton writes, is that while the US Food and Drug Administration (FDA) is willing to cooperate closely with the European Medicines Agency (EMA) on drug...
  • Brazilian Pharma Sector Submits Drug Waste Proposals

    After several extensions of the deadline by the Brazilian government, the Brazilian pharmaceutical sector has finally submitted three suggestions to the Ministry of Environment for a pharmaceutical sectoral agreement on the disposal of medicines by consumers  . After review by the Ministry, a final proposal will be submitted for consideration to the Steering Committee for the Implementation of Reverse Logistics Systems (CORI), which is coordinated by the Ministry ...
  • Brazil Pushes Ahead With New Environmental Protection Plan Focused on Drug Disposal

    Brazil's Ministry of Environment (MMA) has issued a final deadline for the pharmaceutical industry to submit its own proposal on how to implement an agreement intended to ensure the environmentally sound disposal of medicines and packaging after use by consumers. The 2010 sectoral agreement requires industry to implement the mandated drug disposal measures within five years in all cities with more than 100,000 inhabitants. This is the third deadline set by the govern...
  • CDSCO Clarifies the Role of its International Unit

    India's Central Drugs Standard Control Organization (CDSCO) has posted the organizational structure and functions of its recently-formed International Cell , which interfaces with foreign governments and regulatory agencies and investigates reports of quality concerns with India drug exports.  Among its other functions, the Cell focuses on bilateral Memoranda of Understanding (MOUs), grants written confirmations for active pharmaceutical ingredient (API) exports f...