At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication and collaboration we ensure that we, and our clients, can be part of the cutting edge in the pharmaceutical industry.  

We recently invited one of the largest global pharmaceutical companies to present in our RIM Leaders Forum concerning eCTD 4.0 Pilots and how best to prepare for them. Through the work we have done together we have successfully submitted multiple FDA eCTD 4.0 sequences during the pilot scheme.  

This blog will cover some of the key points in preparing for an eCTD 4.0 pilot. 

Why Pilot? 

At this point in time, both Health Authorities and Applicants have very little experience in preparing and reviewing eCTD 4.0 submissions. 

• Health Authorities want to test their validation/review tools, verify their Regional Implementation Guide is correct, and ensure their business processes are working. 

• Applicants will want to test their Publishing, Validating, and Viewing tools, develop processes and provide feedback to both the HA and their solutions vendor. 

Starting discussions with your vendor when you are considering participating in a pilot will ensure you are both in the best position to be ready.  

Pros and Cons 

There are both Pros and Cons to participating in a HA pilot and these should be weighed in making your decision to proceed. 

Pros 

• Be the first to experience new requirements and submit using the new standards.
• Build confidence in the emerging standards and ability to educate learnings and benefits to the wider organisation.
• Allow applicants to develop real-world business processes.
• Test vendor tools and provide feedback, shaping their development.
• Technical pilots are not live and have no impact if errors occur during the submission process.
• Gain recognition from the HA for participating and elevate the company’s status.
• Use the experience to present at conferences and share experience with your peers in industry 

Cons 

• Technical standards are likely to change following the pilot, which will mean solution and process updates may be needed.
• Resources involved in the pilot will need to be trained in eCTD 4.0 and made available during the pilot period.
• Being unable to commit once signed up may be viewed negatively by the HA which may result in not being invited to participate in future pilots. 

Discussion with Health Authority and Vendor 

When discussing suitability with the HA it should be confirmed: 

• Which ICH/Regional eCTD v4.0 implementation guide they are using.
• Which procedures are covered and number of submissions that can or should be made during the pilot.
• Whether the pilot will use dummy files or live applications.
• Whether the HA has a review system vendor. Will it be ready for the pilot, and will they provide validation results? 

When discussing suitability with the Vendor it should be confirmed: 

• Can the Vendor provide a solution in time to support the pilot.
• How can the solution be accessed.
• Which documents will the solution have access to i.e. dummy documents/real documents.
• What support can the vendor provide during the pilot – process, technical etc.

Risks and Committing to Pilot 

Certain risks will need to be assessed when joining a pilot.  

There may be instances where multiple pilots are being launched concurrently. Companies should consult stakeholders and determine which pilots are a priority. Solutions may also be not fully functional which could require a SME or technical consultant to validate or troubleshoot issues. Not being able to complete the pilot, or lacking resources to cover both the pilot and regular submissions, will be detrimental to the company’s standing with the HA. 

Before committing to a pilot, companies should: 

• Hold internal discussion with key stakeholders to determine the viability and desire to participate in the pilot.
• Contact the vendor to confirm they will have a solution ready for the pilot.
• Identify key figures who will be trained in and lead the pilot submissions.
• Contact the HA to declare interest and confirm participation.
• Identify the requirements once published and ensure training is completed prior to pilot start date.
• Meet regularly with Vendor and HA to provide updates throughout the pilot. 

Once the pilot is completed all learnings/process improvements should be documented and disseminated for future pilots. It is also worth sharing these experiences with other companies to further aid them in remaining compliant and ensuring patients have access to the medicines they need.