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  • Feature ArticlesFeature Articles

    A Comparative Analysis of Drug Lag in Emerging Markets

    "Drug lag" is the delay in introduction of a new drug into a country. The concept of drug lag was first brought up by William Wardell, a pharmacologist at the University of Rochester School of Medicine. After living in New Zealand and the UK for several years, Wardell realized that several drugs being sold abroad were not available in the US. Wardell published a study  showing that from 1962 to 1971, the UK introduced more new chemical entities (NCEs) and at a faster...
  • Brazil Opens Consultation on 2013-14 Regulatory Agenda

    Brazil's National Health Surveillance Agency (Anvisa) has opened up its 2013-2014 Regulatory Agency for public consultation and comments, it announced this week. The Preliminarily Proposed Themes were developed through discussions held within the agency and target 78 regulatory measures of which 63% were continued from the 2012-2013 Agenda.  The consultation is open to so-called participating entities that are qualified according to the following criteria: an ...
  • Brazil Drops International GMP Inspection Proposal

    The Board of Brazil's national regulatory agency, Anvisa, has abandoned a draft resolution that proposed how the regulatory agency would conduct overseas current good manufacturing practice (CGMP) inspections at medical device and in vitro diagnostic (IVD) manufacturing sites. Regulators cited comments indicating that the high cost of the inspections would outweigh the benefits of the proposal for the withdrawal of the draft resolution. Moreover, elements of the earli...
  • 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...
  • Brazil Clarifies Informed Consent Requirements

    Brazil's National Health Surveillance Agency, Anvisa, has released a notice clarifying the rights of individuals who participate as clinical research subjects in the country. The notice specifies that clinical trial subjects must be informed that Brazilian law prohibits compensation for participating in a trial with the exception of being reimbursed for the cost of transportation and meals. The notice also states that a clinical trial subject has the right to lea...
  • Brazilian Regulatory Authorities to Expedite Minor Labeling Changes

    Brazil's national regulatory authority, Anvisa, has announced that its Board has approved an amendment that will permit its regulators to immediately approve minor labeling changes upon notice by a pharmaceutical company. The new rule, approved 12 December 2012, covers changes that pose no risk to the consumer such as safety information and packaging color, size, and layout of patient leaflets and package labeling. According to the CEO of Anvisa, Dirceu Barbano, the ne...
  • Cuba-Brazil Bilateral Agreement Fosters Drug and Vaccine Development

    According to the director of Brazil's national regulatory agency (Anvisa), Dirceu Barbano, the cooperative exchanges of regulatory information and technology facilitated by a bilateral agreement between Cuba and Brazil have been "beneficial" in the development of new drugs and vaccines. The two countries have established a cooperative framework through which they have produces millions of meningococcal vaccines intended for use in Africa. According to reports, the agreem...
  • 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...
  • 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 ...
  • Brazil's Anvisa Addressing Drug Approval Priorities

    Brazil's national regulatory authority, Anvisa, announced on 4 October a number of steps it has implemented to address the priority public health needs of the country, part of a multi-year reorganization aimed at better addressing the health and economic development needs of the country and its population. One of the measures it has implemented is the establishment of an expedited review and approval procedure for medicines deemed to be priority treatments for use by t...
  • Brazil: Anvisa Issues New Technology Transfer Regulation for Local Companies

    Local Brazilian companies will be the beneficiaries of a new technology transfer  regulation that is intended to reduce the country's dependence on foreign drug imports and technology.  The regulation, approved by the Board of Brazil's national regulatory agency, Anvisa, on 13 September 2012, establishes procedures for local companies to enter into drug development and technology transfer partnerships with the National Health Service (SUS).  The regulatio...
  • Brazil: Strike May Prompt Drug Shortages

    [Editor's note: the majority of Brazilian regulatory authorities ended their strike on Monday, 3 September 2012 according to Reuters . Approximately 10% of workers remain on strike.] The Brazilian press is claiming that the ongoing strike of employees at the country's National Health Surveillance Agency, Anvisa, is threatening to create drug shortages throughout the country.   "In the hospitals, concerns have grown over shortages of essential medicines an...