• Regulatory NewsRegulatory News

    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...
  • 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 ...