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    FDA Releases New Electronic Submission Requirements for Biological Products

    A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) outlines a new process of submitting lot distribution reports (LDRs) in electronic format. Background As required by 21 CFR 600.81 , LDRs are used to update FDA regarding the quantity of a product distributed under an approved biologics license application (BLA). Those reports are required to be submitted at least every six months, though FD...
  • EMA Tries to Clamp Down on Revolving Door of Regulators

    EU regulators have released a new "best practices" guide intended to steer the European Medicines Agency (EMA) clear of the types of perceived conflicts of interest that plagued the agency's former leader. Background In 2012, EMA was publicly chided by the European Court of Auditors (ECA), which said it had inadequately managed situations involving conflict of interest (COI). While those COIs spanned a wide number of areas, among the most critical identified was the ...
  • Feature ArticlesFeature Articles

    Good Clinical Practice: Where Ethics and Quality Meet

    What Is Good Clinical Practice (GCP)? When clinical research professionals are asked why they do things the way they do, they often reply, "because it's GCP!" Good Clinical Practice, or GCP, should form the foundation for all activities that take place within clinical research.  The US Food and Drug Administration (FDA) defines GCP as: "A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials th...
  • Revised EU Distribution Rules Target Falsified Medicines

    The European Commission issued final revised Good Distribution Practices (GDP) guidelines  on 8 March 2013 that are designed to incorporate the requirements of a 2011 Directive that targets so-called "falsified medicines" from entering the legal supply chain of the EU.  A draft version of the revised GDPs was issued for public comment (consultation) in July 2011 by the Commission, which noted at the time that the 1994 version of the GDPs was "no longer adequa...
  • 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...
  • India's CDSCO Finalizes Guideline on Good Distribution Practices for Biologicals

    India's Central Drug Standards Control Organization (CDSCO) has finalized and released a new guideline on good distribution practices for biological products manufactured in the country. Regulators said the guideline , originally released in late September 2012 in draft form , is intended to, "Assist in ensuring the quality and identity of biological products during all aspects of the distribution process."  Guidelines on Good Distribution Practices for Biologic...
  • 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...
  • FDA Looks to Support Animal Rule With New GLP Training Program

    • 15 June 2012
    How do you ensure regulatory compliance in the world's most dangerous laboratory environments? The US Food and Drug Administration (FDA) wants to know, and is proposing to put money behind an initiative it says is aimed at supporting its 'Animal Rule' by developing an academic-based training program to educate pharmaceutical professionals working in high containment environments on good laboratory practices (GLPs). In an advanced posting of an 18 June Federal Register ...
  • Feature ArticlesFeature Articles

    Pitfalls in Good Clinical Practice

    A pitfall can be defined as a potential and usually unanticipated disaster or difficulty. 1 When we perform clinical studies we try to anticipate unforeseen pitfalls before they arise. However, other occurrences are clearly foreseeable, yet we permit them-or cause them-to happen. Good Clinical Practice (GCP) refers to international standards of quality for the performance of clinical studies with human subjects. These standards aim to ensure the data generated are h...
  • Paper Looks to Establish Best Practices for Evaluating Effectiveness of Regulations

    A white paper released by Mini-Sentinel, and adverse event tracking pilot project, evaluates a series of existing studies evaluating the impact of the US Food and Drug Administration's regulatory actions, finding those studies to be largely lacking. The paper, published 12 March and released to the public on 5 April, sought to answer two questions: what regulatory methods have been used by FDA, and what are the best practices for evaluating regulatory actions? The two-p...
  • USP Releases Proposed Standard on Supply Chain Integrity and Counterfeits

    The US Pharmacopeia (USP) released new proposed standards last week that are aimed at securing global supply chains and preventing counterfeit medicines from propagating. The standards-composed of a series of best practices-would ensure that: products are traceable to their original manufacturers; product integrity is ensured in both substance and identity; and product quality is maintained from manufacturer to consumer Further, the best practices would ensure th...