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Biosimilars, supply chain security, quality metrics, and elemental impurities headline guidance topics on FDA’s 2015 agenda.
In releasing its annual list of proposed guidance for industry docments, for 2015, FDA’s Center for Drug Evaluation and Research (CDER) mapped an ambitious agenda for key areas. Of the 90 proposed documents listed on the guidance agenda for 2015, four focus on biosimilarity, 13 on pharmaceutical quality/CMC; and three on pharmaceutical quality/cGMPs. Quality metrics, elemental impurities, and supply-chain security are other key areas targeted for proposed guidances.
FDA guidance documents are not legally enforceable, but describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited, FDA notes.
In December 2014, the International Conference on Harmonization (ICH) released long-awaited revisions to standards for elemental impurities in drug products, ICH Q3D Guideline for Elemental Impurities for implementation by regional authorities. In January 2015, the United States Pharmacopeial Convention announced an implementation timeline of January 2018; the European Medicines Agency set implementation for new drug products for June 2016 and existing products for December 2017. FDA has not announced implementation dates, but listed a guidance, Elemental Impurities in Drug Products Marketed in the United States, for release some time in 2015.
FDA’s 2015 guidance agenda includes six documents related to the implementation of the Drug Supply Chain Security Act (DSCSA). A December 2014 guidance, DSCSA Implementation: Product Tracing Requirements Compliance Policy, delayed enforcement of regulations for trading partners. Industry players have complained that FDA’s DSCSA-related guidance documents thus far have been limited and fail to answer questions presented by industry.
Proposed guidances include the following:
Pharmaceutical Quality/Manufacturing Standards (CGMP)
Drug Supply-Chain Security
A complete list of proposed guidance documents is available on www.fda.gov. For draft and final guidances, FDA offers an online search to facilitate access to guidance documents. Users can search for documents by keywords, then filter results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.
Article DetailsPharmaceutical Technology
Vol. 39, Issue 2
When referring to this article, please cite it as:
R. Peters, “FDA Sets Agenda for 2015 Guidance Development," Pharmaceutical Technology 39 (2) 2015.