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  • EU’s Scientific Committees to Look at Synthetic Biology

    The European Commission's three Scientific Committees have been requested to provide a joint scientific opinion on the relationship of Synthetic Biology (SB) to genetic modification of organisms, its implications for human and animal health and the environment, and the major gaps in knowledge necessary for performing a reliable risk assessment. Synthetic Biology is the term used to describe the creation of biological systems that do not exist in nature using engineeri...
  • TGA Opens Consultation on New-to-Market Communication Proposal

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation to seek views from interested parties on the value, feasibility, design and impacts of a proposed new-to-market risk communication scheme. A new-to-market risk communication scheme is intended to signal to people using therapeutic products that a particular product is new, or newly available for a particular use.  For example, in the EU, a small black triangle is placed next to the name ...
  • Deborah Autor, One of FDA's Top Regulatory Officials, Leaving Agency

    The US Food and Drug Administration (FDA) announced today that one of its top regulatory officials, Deborah Autor, deputy commissioner for the office of Global Regulatory Operations and Policy (GO), will be leaving the agency shortly to join Mylan Pharmaceuticals. Autor's departure is at least the third major staff shakeup in recent days. Yesterday, FDA announced the hiring of a new Deputy Commission for Policy, Planning and Legislation, Sally Howard, and a new director ...
  • China Orders Foreign Drug Companies to Designate Local Agents

    China's State Food and Drug Administration (SFDA) issued a Notice on 29 January 2013 to provinces, municipalities and ports concerning the implementation of the national electronic monitoring system for imported pharmaceuticals, which will require foreign-based companies to have a local designate. Foreign companies must designate a local Chinese pharmaceutical company, pharmaceutical wholesaler, subsidiaries or offices as their electronic monitoring agent in China.&nbs...
  • China Sets Deadlines for Drug GMP Implementation

    China's State Food and Drug Administration (SFDA), the National Development and Reform Commission, the Ministry of Industry and Information Technology, and the Ministry of Health issued on 21 December 2012, a joint notice to the provinces and municipalities setting forth deadlines for implementation of the revised good manufacturing practices (GMPs) by the pharmaceutical industry.  Injectable drug manufacturers must implement the revised GMPs by 1 January 2014, a...
  • India Issues Draft Drug GDP Guidance

    India's Central Drug Standards Control Organization (CDSCO) released on 10 January 2013  draft guidelines  on good distribution practices (GDP) for pharmaceutical products intended to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. Elements of the process include, but are not limited to, procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices.  The...
  • 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...
  • Health Canada to Open Clinical Trials Database

    As of April 2013, Health Canada intends to provide public access  to its own clinical trial database covering Phase I, II and III drug trials that have been authorized in Canada. The database is seen as an interim measure that will provide only basic information on each trial such as the protocol title, study population, and sponsor.  The establishment of a formal Canadian trial registry is being considered for implementation at a later date. Health Canada's ...
  • 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...
  • PCORI Board Adopts CER Standards

    The Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI) at its 19 November 2012 meeting in Boston, MA adopted 47  revised methodology standards  that are intended to guide the comparative effectiveness research (CER) funded by PCORI.  The Board also authorized at the meeting the development of three new CER funding announcements: Treatment options for uterine fibroids, the safety and benefits of treatment options for severe asthm...
  • Consultation Opened on Impact of 'Black Symbol' on Industry

    The European Commission has opened a consultation on the time needed by companies to implement product packaging changes under the new EU pharmacovigilance law. Under that legislation, companies are required to incorporate a black symbol on certain drug products subject to additional monitoring because of their specific safety profile. The Commission is considering the need for phasing in the black symbol in the summary of product characteristics (SmPC) and the package ...
  • New Advisory Body to Australian Regulator to Guide Reforms

    The Australian Government has created a new advisory body for the Therapeutic Goods Administration (TGA) with the mandate to advise TGA on communication with stakeholders, on new agency management initiatives and to monitor the agency's progress on its ongoing Blueprint for Reform agenda. The Australian Therapeutic Goods Advisory Council (ATGAC) consists of 15 "eminent health care professionals" that will be chaired by Australia's Chief Medical Officer, Professor Chri...