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  • China Implements Revised Good Quality Control Standards for Drugs

    The China Food and Drug Administration (CFDA) has announced that as of 1 July 2013, new start-up pharmaceutical companies must comply with the requirements of the revised Drug Quality Control Standards for obtaining a qualifying Drug License certificate and Drug Good Manufacturing Practice (GMP) certificate. The requirements will also apply to warehouses and pharmaceutical enterprises that apply for certification of new, renovated or expanded business premises. Compa...
  • Chinese Provinces Get Class III Device and IVD Inspection and Approval Authority

    The China Food and Drug Administration (CFDA) has issued a notice regarding adjustments to the duties undertaken by provincial food and drug supervision and management departments, part of an effort to implement the State Council institutional reform and functional transformation plan to further the reform of administrative evaluation and approval of medical devices. The notice points out that as of 1 October 2013, the provincial Food and Drug Administration department...
  • India to Require Notification of Foreign Drug Import Alerts

    Indian pharmaceutical companies will now be required to inform the Central Drugs Standard Control Organization (CDSCO) about any drug import alert restrictions imposed on their products by foreign regulatory authorities, according to a new notice issued on 26 June 2013 by the Drugs Controlled General of India (DCGI). The notice highlights the fact that local manufacturers whose drugs are the subject of foreign regulatory action also supply the same or similar drugs on ...
  • ANZTPA Launches Joint Adverse Event Notifications System

    The Australia New Zealand Therapeutic Products Agency (ANZTPA) has launched an adverse event reporting database, the Joint Adverse Event Notifications System (JAENS), that combines drug and device adverse event reports received by Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe). Reports come from a wide range of sources, including members of the public, general practitioners, nurses, other h...
  • Anvisa Proposes Mandatory Notice for Manufacturing Suspension

    The Board of Brazil's National Agency for Sanitary Surveillance (Anvisa) has opened a consultation on a proposal that would require companies to provide at least 180 days of advance notice to Anvisa prior to discontinuing, reducing or temporarily suspending the manufacture or importation of essential drugs.  In cases where the action is being taken due to technical reasons that could impact drug quality, safety and/or efficacy, notice would have to be provided to...
  • Manual of Brazilian Nonproprietary Names Launched

    Brazil's National Agency for Sanitary Surveillance (Anvisa) has launched the country's first Manual of Brazilian Nonproprietary Names (MDCB), drawing on legislation related to the Brazilian Common Denomination (DCB) system and its supplemental tables. The Manual, which launched on 26 June 2013, contains over 11,000 designated names and permits the standardization of names for the identification of generic drugs and for drug procurement. The launch is part of the II ...
  • Canada Issues Guidance on Determining Rx Drug Classification

    Health Canada has issued guidance on Determining Prescription Status for Human and Veterinary Drugs that explains the principles and factors that the agency considers when deciding whether a drug should be classified as a prescription or non-prescription product. The guidance applies to both human and veterinary drugs and to all additions and removals from the list of prescription drugs that replaced the Food and Drug Regulations' "Schedule F" in 2012, although it doe...
  • Australia’s TGA Releases Principles of Good Consultation Practices

    Australia's Therapeutic Goods Administration (TGA) has issued its Consultation Principles governing how the agency conducts its public consultation process on regulatory issues, including fundamental changes to primary legislation and minor administrative changes to internal procedures.  According to the TGA, the Principles have been developed in order to: Improve transparency - encouraging participation in the regulatory system and to keep stakeholders informe...
  • Australia Proposing 12 Month Trial Period for OTC Monograph Process

    Australia's Therapeutic Goods Administration (TGA) opened a consultation on 18 June 2013 on the implementation of a 12-month trial period of an Over-the-Counter (OTC) New Product N2 application (or Monograph application) route to market. N2 applications will involve significantly reduced requirements for data assessment and consequently shorter evaluation timelines. Instead of providing full supporting data with the application, sponsors will only need to confirm that...
  • Australia’s TGA Launches Database of Adverse Event Notifications

    Australia's Therapeutic Goods Administration has launched a new Database of Adverse Event Notifications (DAEN), an online resource that will provide the public and the health care community with access to adverse event reports. The database, which will be updated monthly, includes reports from January 1971 up until three months prior to the date of access to allow the agency to investigate new reports.   The database currently contains around 251,000 reports...
  • Ireland Implements Reference Pricing to Boost Use of Generics

    The Health (Pricing and Supply of Medical Goods) Act of 2013, enacted in Ireland on 28 May 2013, introduces a system of generic substitution and reference pricing for medicinal products in Ireland. The Irish Medicines Board (IMB) has published guidance detailing its responsibilities under the Act and the process for creating the mandated List of Interchangeable Medicines. Reference pricing involves the setting of a common reimbursement price, or reference price, for a...
  • Australia Proposes Guidance on Role of Authorized Person in Drug Manufacturing Process

    Australia's Therapeutic Goods Administration has opened a new consultation on proposed guidance regarding the individual (known as the Qualified or Authorised Person) that must certify that a drug has been manufactured according to the requirements of the marketing authorization and cGMPs.  The Australian system is different from the European system of batch release by a Qualified Person, which is why the current PIC/S Guide to Good Manufacturing Practice for Med...