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  • China's Communist Party Calls for Reforms to Drug Regulatory System

    China's Communist party has called for the comprehensive reform of its food and drug regulatory system in order to respond to the concerns of its people, part of a group of reforms called for at a 16 November 2012 meeting of the Communist Party of China's National People's Congress. The focus of the called-for reforms is on improving food and drug safety and the institutional regulatory mechanisms that are tasked with that mandate, explained China's State Food and Drug A...
  • UK Patient's Access to 'Breakthrough' Melanoma Therapies Delayed by NICE

    UK melanoma patients still cannot get access to BMS' Ipilimumab (Yervoy), approved for Europe-wide marketing on 13 July 2011, or Roche's Vemurafenib (Zelboraf), approved on 20 February 2012.  The barrier to patient access has been the UK cost containment agency, the National Institute for Health and Clinical Excellence (NICE), which admits both new drugs are "breakthrough treatments" for melanoma patients.  But NICE has refused to clear the drugs for...
  • Brazilian, Global Regulators Focus on Pharmacovigilance

    Together with the World Health Organization (WHO) and the Pan American Health Organization (PAHO), Brazil's National Health Surveillance Agency (Anvisa) recently hosted two international meetings on pharmacovigilance in Brazil, bringing together countries from Latin America and around the globe. Both meetings provided the opportunity to further integrate post-marketing surveillance activities in the Latin American and Caribbean region. Delegations from 59 countries, incl...
  • China's SFDA Issues Rule on Imposing Administrative Penalties

    China's State Food and Drug Administration (SFDA) issued a  notice  to the Provinces and Autonomous Regions regarding the application of its Administrative Punishment law, which sets forth the rules for imposing sanctions for violations of the laws and regulations governing drugs and devices.  Local authorities are allowed leeway in deciding the severity of the penalty that is to be imposed on a case-by-case basis, taking into consideration the nature of ...
  • Brazilian Regulators: Development, Oversight of Nanotechnology Products a Priority

    Brazil's National Health Surveillance Agency (Anvisa) met on 31 October 2012 to discuss the potential impact of nanotechnology on various fields, including medicines and biology, and how the technology could be used to benefit the country's national strategic priorities on public health and industrial development. The use of nanotechnology has been associated with potential risks to human health, and Anvisa regulators made clear that the agency sees its role as both a ...
  • China Classifies, Reclassifies Dozens of Medical Devices After Review

    Following a review conducted by its experts, China's State Food and Drug Administration (SFDA) notified provincial and municipal agencies on 12 September 2012 of the classification of 73 medical devices. Nine devices were classified as Class III (implanted or life supporting devices); 41 as Class II (controls needed to ensure safe use); three as Class I (safety assured through routine administration); and 20 reclassified as non-devices.  Examples of new classif...
  • India's CDSCO Orders Local Authorities to Adhere to Drug Regulations

    India's Central Drugs Standard Control Organization (CDSCO) issued directions to local authorities on 12 October 2012 to comply with the requirements of the national Drugs and Cosmetics Act concerning the grant of licenses for new and generic drugs.  For generic drugs, local authorities were told that licenses can only be granted for generics under the generic name of the formulation, In the case of formulations containing multiple ingredients, the license should...
  • Japan's PMDA Reorganizes Biologics Offices

    Japan's Pharmaceutical and Medical Device Agency (PMDA) has reorganized its Offices of Biologics I and Biologics II, respectively, into new entities known as the Office of Cellular and Tissue-based Products and the Office of Vaccines and Blood Products. As of 1 October 2012, the Office of Cellular and Tissue-based Products will be responsible for cellular and tissue-based products, CMC of gene therapy products, CMC/quality of biologics, biosimilars, and Cartagena Act ...
  • Countries Responsible for EU-wide Safety Monitoring Announced

    The European Medicines Agency (EMA) published on 5 October 2012 the first list of EU member states responsible for monitoring the safety of specific active substances across the EU.  In effect, each listed country will be responsible for monitoring specific medicinal products that have been approved for marketing in more than one EU member state through either the national, mutual recognition or decentralized procedures.  The monitoring data that each coun...
  • China: New Labeling Requirements for Imported Devices

    Chinese authorities have announced that as of 1 April 2013, all text appearing on the outside labeling and packaging of imported medical devices must be in Chinese, according to a notice issued to provinces, autonomous regions and municipalities by China's State Food and Drug Administration (SFDA) on 24 September. The Chinese text version can be "attached" to the foreign language, though it is unclear what forms will be permitted. Any devices not in compliance with the r...
  • Health Canada Expands Use of Foreign Data

    Health Canada announced on 28 September the expansion of its pilot project on the use of drug review assessment information from foreign regulatory agencies, such as the European Medicines Agency, in its own marketing authorization review process.   The Use of Foreign Reviews pilot project was first initiated in October 2011 to test whether access to such data would assist Health Canada in meeting its regulatory assessment "targets" by speeding up the applica...
  • China: SFDA Issues New PSUR Guidance

    New guidance on submitting periodic safety update reports (PSURs) for drugs was released by China's State Food and Drug Administration (SFDA) on 6 September.  The guidance conforms to the harmonized PSUR standards developed by the International Conference on Harmonization [ICH E2C (R1)].  Foreign importers and joint ventures must submit Line Listings, summary tables (Summary Tabulations) and the company's core data table (Company Core Data Sheet, CCDS) transla...