eCTD is Here: Six Imperatives to a Sound Publishing Strategy
The FDA’s mandate for requiring that all drug applications be submitted in the Electronic Common Technical Document (eCTD) format takes full effect in May 2017, and while that may seem far away, implementing eCTD can take time and make significant demands on internal resources – no matter where you are in your eCTD journey. (In the EU, eCTD already is the EMA’s preferred format for centralized submissions, and plans for a single EU-wide eSubmission portal could be realized by 2018.)
As the global harmonization of standards proceeds, every company is going to need a modern, compliant information management and publishing infrastructure, whatever their size or experience level:
- Large companies are likely to have a well-established eCTD-compliant publishing process already, but may need to update their workflow, or train authors to write compliant documents.
- Smaller companies, with limited eCTD resources and expertise, may be scrambling to play catch up as deadlines loom.
Since helping prepare the first eCTD ever filed in Europe in 2003, PAREXEL has been a market leader in the support of eCTD submissions. We recently identified “Six Imperatives for a Sound eCTD Strategy” that explains what companies need to do to accelerate their electronic regulatory submissions process while mitigating the risks of delays (and lost revenue opportunities):
- Give authors the right tools to create eCTD-compliant content
- Harmonize data, document, and submission standards
- Optimize processes to stay on top of evolving regulations
- Validate output for efficient publishing
- Utilize an integrated, centralized, end-to-end Regulatory Information Management (RIM) platform
- Scale regulatory resources for the task at hand
Tools that Work
With the right tools and resources, companies can execute a robust eCTD strategy whether they’re building a system from scratch, or fine-tuning an existing operation. For example, formatting problems are among the most common things that go wrong with eCTD submissions. Software that contains templates and macros can prevent them. PAREXEL’s LIQUENT® SmartDesk for Authoring™ tool contains over 300 Microsoft Word document templates, and was designed specifically to streamline the production of compliant regulatory dossiers.