• Two New Indian Advisory Committees to Generate New Guidelines for Clinical Trials, Drugs

    The Drugs Controller General of India (DCGI) for the Central Drugs Standard Control Organization (CDSCO) has requested input from the public regarding two newly formed independent advisory committees. The first committee, the Expert Committee to formulate policy guidelines and SOPs for approval of new drugs, clinical trials and banning of drugs, will be chaired by Prof. Ranjit Roy Chaudhury and include six other members. The committee's charge will be to fo...
  • Australia's Overhaul of OTC Guidelines Attracts Industry Comments, Proposed Revisions

    Australia's Therapeutic Goods Administration (TGA) has released responses submitted to the agency regarding a draft guideline set to change the way the regulator oversees over-the-counter (OTC) medications. The guidance, Australian regulatory guidelines for OTC medicines (ARGOM) , was first published in 2003, and since then has only undergone two minor updates in early 2011. In early 2012, TGA released a major planned update to the ARGOM, including the way it plans to ...
  • Australia to Launch Consultation on Development of eCTD Guidelines, Timetable

    Australia's Therapeutic Goods Administration (TGA) is preparing to establish procedures, guidelines and a timetable for the implementation of the submission of medicine applications using the electronic Common Technical Document (eCTD), it announced on 9 October. The eCTD is an electronic, module-based regulatory application format developed and maintained by the International Conference on Harmonisation (ICH). The basic premise of the eCTD is to harmonize the layout a...
  • India's CDSCO Releases New Draft Distribution Guidelines

    New draft guidelines published on 17 September by India's drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), establish new Good Distribution Practices (GDPs) for biological products. Guidelines on Good Distribution Practices for Biological Products is intended to, "Assist in ensuring the quality and identity of biological products during all aspects of the distribution process," CDSCO writes in the guideline. "These aspects include, but ...
  • EMA Releases Additional Pharmacovigilance Guidelines, Announces Closure of Committee

    The European Medicines Agency (EMA) announced today (26 July) the release of two additional guidelines on good pharmacovigilance practices (GPhVPs) and the shuttering of its Pharmacovigilance Working Party. In a statement , the agency said the working party has been phased out of its original charge-given to it at the time of the agency's founding in 1995-to provide advice on the safety of medicines. Its duties will now be absorbed by a newly-established Pharmacovigila...
  • Proposed Legislation Would Require FDA to Develop Guidelines to Ensure Scientific Quality

    A bill proposed in late June 2012 by a bipartisan group of congressmen would require all federal agencies, including the US Food and Drug Administration (FDA), to develop guidelines to ensure "scientific information relied upon by the agency" meets a number of quality standards. The bill, H.R. 5952 - To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the ...
  • EMA Issues Guidelines on Development of Antibacterials

    The European Medicines Agency (EMA) today released a guideline titled, Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections . The document was approved last month at the 15 December 2011 meeting of the Committee for Medicinal Products for Human Use (CHMP) meeting, and is due to come into effect on 15 January 2012. The guideline was formulated by EMA to further clarify aspects of the antibacterial agent development process t...