Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The regulatory process of electronic submission and its optimization

Dr. Yuan Zhao (Abschlußjahr: 2014)

Summary
Language: English
The electronic Common Technical Document (eCTD) was developed by International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in order to make regulatory submission easier and more efficient. It becomes a common global standard for approval of a new drug and maintenance of already marketed drugs in the US, EU and Japan. eCTD has been required for Centralized Procedure (CP) applications to the European Medicines Agency (EMA) since 2010 and it will be required for all New Drug Applications (NDAs), Biologics License Application (BLAs) and Abbreviated New Drug Applications (ANDAs) to the Food and Drug Administration (FDA) in 2015. Use of the eCTD is also strongly encouraged in Canada, Switzerland and health authorities in developed markets around the world.
The eCTD benefits health authorities (HAs) by allowing assessors to use computer-based tools such as searching, copying and pasting text, making the review process more efficient. The review of application dossier can be completed online, allowing for more timely reviews to meet legislative timelines, which ultimately benefits applicants, as well. For pharmaceutical companies, eCTD submissions can be less expensive to produce and ship.
Since the introduction the eCTD in FDA, submissions to FDA using the electronic format have continued to grow steadily. In FDA eCTD submission was about 9% of NDAs and 6% of INDs in 2007 and increased to around 73% and 58% of NDAs and INDs in 2011, respectively. In EMA the number of eCTD submissions spiked almost 50% in a six-month period spanning 2007 and 2008. The volume of eCTD submissions grew from 1,435 in the second half of 2007 to 2,122 by the end of the first half of 2008. In the future, the paper CTD is destined to be replaced by its electronic counterpart, the electronic Submission. In ICH regions eCTD format will be the only accepted electronic format by HAs.
FDA and other regulatory authorities use software to validate applicant’s eCTD submission. Agencies have become more strict on the eCTD compliance with the validation criteria. In addition, the evolution of regulatory requirements (eCTD, electronic Application Form, Risk Management Plan, etc) is quite fast and often.
Failure to pass the validation process will result in HAs refusing to receive the submission and the applicant will be asked to correct the errors and resubmit. Even a submission passes technical validation, during the management validation several medium severity errors combined with lack of navigation aids in the form of table of contents (ToCs), bookmarks and hyperlinks could still lead to a “refuse to file”.
Therefore, to ensure the successful acquisition of Marketing Authorization (MA) pharmaceutical companies must have properly refined business processes to accommodate the change from the paper-based format to an all-electronic one. In general, the regulatory process of electronic submission can be divided into four steps:

  • Early planning and management of the project;
  • Document preparation;
  • Dossier publishing;
  • Dossier submission

In each step the following basic principle should be complied:

  • To agree on the process
  • To define user’s responsibility and requirements
  • To communicate (between the different function groups)
  • To establish the Standard Operating Procedure (SOPs) and train the users
  • At the end of the step: assessment and review of the process

In addition to these basic principles, each step can be optimized according to type of applications, or complexity of the submission, to adapt the business process to comply with regulatory submission regulation and to increase the efficiency in preparation and management of electronic submission.
Pages: 54

 

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