The pharma industry operates in a dynamic and ever changing global environment governed by new regulations and mandates introduced by the Health Authorities. To get compliant with these mandates, companies are required to submit relevant information about their products to health authorities. Earlier these submissions were made in the form of CTD (Common Technical Document) which was a paper based standard to submit relevant product data to health authorities.
CTD was a joint venture of three regulatory agencies namely: FDA (Food and Drug Administration), EMA (European Medicines Agency) and PMDA (Pharmaceuticals and Medical Devices Agency). In other words, CTD was a common format for submissions for Marketing Authorizations. ICH believed that this single format of submission will benefit the sponsors saving their resources and time along with managing dossier preparation effectively.
The key benefits offered by CTD were:
- Getting the medical products registered in a well-defined and cost-effective manner
- Providing a harmonized standard for new product submissions for marketing authorizations
- Supporting efficient and effective submission lifecycle management across multiple products
Although CTD as a standard was able to harmonize and offer a better submissions format, it also brought along challenges of managing and maintaining huge volumes of paper based documentation both for health authorities and companies.
Shifting from CTD to eCTD
With the aim of overcoming the challenge of managing huge volumes of paper based product data and to enable faster and efficient submissions, an electronic equivalent of CTD was introduced as eCTD. The new standard has proved to be a strategic one proposing substantial benefits to both health authorities and companies. eCTD standard proved to be of a greater value for companies as it improved the submission and reviewing process. eCTD offers a lot of benefits as mentioned below but not limited to:
- It resulted in more precise submissions
- It reduced duplicate submissions because of better organization of documents
- Less storage is required for maintaining the information across multiple product lifecycles
- It is a single application format
- It reduces total cost of submission lifecycle process
eCTD is the submission of (mostly) PDF leaf documents, stored in the eCTD directory structure, crucially accessed through the XML backbone (index.xml) and with the files integrity guaranteed by the MD5 Checksum. It also provisions multilingual and multi-region aspects of submission process.
Apart from this the lifecycle for submission procedure also got categorized into three simple steps:
- New or initial submission
- Re-submission only for what has been changed
eCTD Implementation by Emerging Markets
The major emerging markets have identified the advantages of eCTD over CTD and there is an increasing shift towards adopting and implementing eCTD. Some of the benefits arising out of this shift are:
- Market and Revenue Growth
- A Standardized Process and Format for Submissions
- More Efficient than Paper Submissions
- Decreased Timeline and Faster Approvals
- Improved Tracking Ability
- Enhanced Accessibility, Reporting and Archiving of Submissions
- Superior Visibility of the Procedure
- Reuse of data for Valuation Reports and Lifecycle Management
Knowing the advantages that eCTD has over CTD, countries are now gradually adopting the electronic submission format. Where on the one hand countries like Australia have initiated the process, other countries like South Africa, European Unions, Thailand, etc. are on their way to implement eCTD for their submission.