• Feature ArticlesFeature Articles

    Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions

    This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan. Introduction From clinical trials to marketing authorization, regulatory dossiers for small molecule drug products are incomplete without the presentation of certain regulatory certif...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Proposes Sourcing Requirements for Drug, Device Companies (3 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Proposes Sourcing Requirements for Drug, Device Firms as Traceability Agenda Gathers Pace The China Food and Drug Administration (CFDA) has released another piece of its proposed strategy for implementing a traceability system across the country. In the latest text, the regulator has set out plans to make drug manufacturers assess the quality of their raw material sup...
  • Regulatory NewsRegulatory News

    Indian Regulators, Medical Device Associations Focus on New Guidelines, Increasing Exports

    India’s Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) met with medical device association representatives earlier this month to discuss how the country can become a hub for device manufacturing and begin to align with global regulations. According to the minutes of the meeting, most of the discussion centered on increasing device exports and evaluating new guidance for industry. Draft guidance on good manufactu...
  • Brazil: South American Countries Driving Regulatory Harmonization

    Brazil and Argentina are drivers of regulatory harmonization regionally in South America, said Anvisa Chief Executive Dirceu Barbano, noting the countries' efforts in the region. Both Brazil's and Argentina's respective regulatory agencies are working with Mercosur, a multilateral organization whose mission is to create a common regional market, to harmonize regulations, said Barbano. Barbano's comments were in response to questions posed by Brazilian legislators at a...