• Time for Generic Pharma Companies to Re-Identify Themselves, FDA Says

    The US Food and Drug Administration (FDA) is reminding all manufacturers of generic drug products, including active pharmaceutical ingredients used in generic drug manufacturing, that they need to re-register with the agency under the terms of a 2012 law. Background In the lead-up to the 2012 passage of  The Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA regulators highlighted a growing problem: Many generic drug manufacturers were moving the...
  • FDA Guidance Clarifies Intent of Bioterrorism Law Affecting Dietary Supplements

    The US Food and Drug Administration (FDA) has released a new guidance document intended to clarify elements of a 2002 law passed in the hopes of better allowing the agency to deal with bioterrorism concerns. Background The Public Health Security and Bioterrorism Preparedness and Response Act (PHSBPR) of 2002 was passed months after a series of terror attacks hit the US in 2001. While airborne attacks on the World Trade Center buildings and the Pentagon are almost un...
  • China to Require Registration of all Clinical Trials, Bioequivalence Studies

    China's Food and Drug Administration (CFDA) is requiring clinical trial sponsors to register all trials (Phases I, II, III, IV) and bioequivalence testing, according to World Health Organization (WHO) requirements posted online . The 6 September 2013 bulletin mandates that the required information be posted within one month after pre-registration of the trial, followed by an update within one year. The trial's approval will be revoked if the registration requiremen...
  • Brazil's Anvisa Looks to Streamline Registration Procedures for Drugs, Devices

    Brazil's National Health Surveillance Agency (Anvisa) has signed a technical cooperation agreement with two other Brazilian agencies designed to sustain the country's economic growth and health by streamlining registration procedures for medical products. The agreement, announced on 10 April 2013, brings together Anvisa with the Ministry of Development, Industry and Foreign Trade (MDIC) and the Ministry of Health (MOH). Under the terms of the inter-ministerial agreement...
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    Drug Registration in Brazil: Challenge or Opportunity?

    With its 191 million inhabitants, Brazil is currently the world's eighth largest prescription drug market and has been the target of large investments and significant expectations from big pharmaceutical companies. Registering drugs in Brazil has been a promising strategy for companies from developed countries whose pharmaceutical markets, often governed by repayments, already are saturated and in crisis. These days, the Brazilian National Health Surveillance Agency, AN...
  • Brazil Updates Criteria for Drug Registration

    Brazil's national regulatory authority, Anvisa, has opened a Public Consultation on proposed revisions to the criteria for the technical requirements for quality, safety and efficacy needed to support the registration of new, generic and biosimilar medicines. The consultation, released on 8 January 2013, would replace Resolutions RDC No. 136/2003, RDC No. 16/2007 and RDC No. 17/2007, whose update was prompted by new technological developments. The deadline for comment...
  • FDA Gives More Time to Generic Facilities to Register, Saying Many Have Not

    The US Food and Drug Administration (FDA) is delaying by two weeks the implementation of its facility registration requirements under the Generic Drug User Fee Act (GDUFA) , a subset of a recently passed FDA Safety and Innovation Act (FDASIA) . One of the law's main goals was to achieve parity between the way FDA collects fees from branded and generic pharmaceutical products. Under a long-standing program, FDA assesses user fees from branded pharmaceutical companies ...
  • New Facility Registration Requirements Come into Effect for Supplement Manufacturers

    A new guidance for industry published by the US Food and Drug Administration (FDA) includes information about new registration requirements established under the Food Safety Modernization Act (FSMA) , including for dietary supplement manufacturers. The requirements of FSMA came into effect on 22 October and mandate that all food production facilities-of which supplement manufacturers are by definition a part-register with FDA to mitigate the impact of any potential ...
  • TGA Calls for Biologics Applications in Advance of Deadline

    Australia's Therapeutic Goods Administration (TGA) is reminding all biologics manufacturers that, per a new regulatory framework for biological medicines, that they must re-register their products with the Australian Register of Therapeutic Goods (ARTG) by 31 May 2014 or risk sanctions. The framework is intended to better regulate human tissue and cell-based therapies by classifying biological products based on risk, the agency has said. Under a new "special transitio...
  • FDA Releases Guidance on Facility Registrations, Payments Under GDUFA

    Two new draft guidance documents published by the US Food and Drug Administration (FDA) instruct owners of manufacturing facilities that produce generic drug products on how to comply with the terms of the newly enacted Generic Drug User Fee Amendments (GDUFA) of 2012. GDUFA , enacted as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) , includes among its many provisions one requiring all generic drug facility sites and companies with prod...
  • FDA Final Rule Mandates Electronic Registration of Device Establishments

    The US Food and Drug Administration (FDA) has issued a final rule regarding  electronic device registration and listing requirements, putting into practice a long-awaited rule combining the requirements of several pieces of legislation with a newly-revamped digital registration system. In its 1 August Federal Register posting , FDA said the regulation requires domestic and foreign medical device establishments to register with the agency electronically and will "...
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    East Africa Leads Medicine Registration Harmonization Thrust

    The East African Community (EAC), a regional intergovernmental organization of five member countries including Kenya, Uganda, Tanzania, Rwanda and Burundi, launched its Medicines Registration Harmonization (MRH) Project in March 2012. It was the first of the 12 Regional Economic Communities (RECs) and organizations (see Table 1 ) across the continent participating in the African Medicines Regulatory Harmonization (AMRH) Programme to do so. The launch of the project, wh...