Latest News
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23 May 2013
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The European Medicines Agency (EMA) has announced that its eSubmission Gateway will become mandatory for all electronic common technical document (eCTD) submissions made to the agency through the
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Latest News
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22 May 2013
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The US Food and Drug Administration (FDA) has released a new manual of policies and procedures (MAPP) for its internal drug regulatory staff regarding the creation and maintenance of its electronic
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Latest News
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16 April 2013
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The US Food and Drug Administration (FDA) has issued a new document outlining the process by which sponsors of drug applications should use the electronic Common Technical Document (eCTD), and in
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Under RAPS
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2 April 2013
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The electronic Common Technical Document (eCTD) provides a common global standard for companies to electronically submit the quality, safety and efficacy information required by regulatory agencies. It is an EMA requirement and will soon be required by FDA, so anyone working on drug regulatory submissions needs to understand the format well.
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Latest News
Regulatory Update
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20 March 2013
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Health Canada has announced that as of 1 June 2013, all “administrative regulatory” submissions must be in electronic format only, submitted either as an electronic common technical document (eCTD) or
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Latest News
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12 March 2013
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Some of the largest entities in the pharmaceutical industry, including pharmaceutical manufacturer GlaxoSmithKline and industry trade groups BIO and PhRMA, are weighing in on a recent draft guidance
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Latest News
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12 February 2013
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US Food and Drug Administration (FDA) officials have announced the availability of newly revised final documents that describe the recommended process for regulatory professionals to use when
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Latest News
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29 January 2013
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The US Food and Drug Administration (FDA) has released a new final guidance for industry explaining the E3 Structure and Content of Clinical Study Reports guideline, part of ongoing efforts by
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Latest News
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15 January 2013
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The European Medicines Agency (EMA) has launched its eSubmission Gateway and a new eSubmission web client for the submission of applications for human medicines, it announced on 15 January 2013.The
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Latest News
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3 January 2013
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A long-awaited draft guidance requiring the submission of most pharmaceutical and biological product applications to be done using the electronic common technical document (eCTD) standard has been
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