Poll: 4 of 5 Companies Already Preparing for EU FMD Compliance

By 2019, all pharma companies selling product in the EU will have to follow the requirements of the EU Falsified Medicines Directive (EU FMD). But most organizations actually plan to deploy their EU FMD solution even sooner—75% by next year. That’s the finding based on poll results from our recent EU FMD: What to Know and Where to Start webinar.

Over 160 webinar attendees, representing more than 120 life sciences supply chain companies, gathered to understand the escalating challenges of shipping drug product throughout Europe. How does their progress stack up against that of your organization? According to poll responses from the webinar, most of your peers are already in the active stages of researching and deploying a serialization and compliance solution. And when it comes to implementation, their biggest challenges will involve readiness, infrastructure, and scalability.

Here are the top poll findings:

1.  4 out of 5 are preparing or deploying a serialization program right now.

Polls indicate a belief that to meet the deadline, companies must start now. With less than two years until the official February 9, 2019, deadline for EU FMD, 67% say they are actively researching requirements or designing their plan, while another 15% are in deployment. Only 18% report they are in the early stages of starting to learn about the regulation.

Waiting until the deadline to deploy is a huge risk to both product and patients, and most companies realize they’ll need to start early if they plan to be compliant in time. In fact, 75% of all respondents expect to start deployment by 2018. Within that number, 18% have already begun, 30% will deploy later this year, and 52% will do so by 2018. Just 8% of poll respondents expect to wait until 2019.

2.  Most companies will manage a staggering number of partners.

When it comes to collaboration, one thing’s clear: most companies will need to exchange data with a lot of partners or customers. Nearly half of all respondents (46%) have at least 10 customers or partners they’ll need to work with for EU compliance. Among that group, 46% report they’ll need to connect to 50 or more partners or customers.

With so many partners in the mix, CMOs can’t expect a one-size-fits-all approach will suffice to meet the requirements of their customers. Nor should brand owners be confident their CMOs will all be ready to support their serialization needs. You’ll need to begin collaborating early so you’re connected and ready to exchange data with others in your network ahead of the deadline.

3.  Readiness, infrastructure, and scalability are the biggest challenges.

Beyond shipping actual product, companies must exchange massive volumes of serialized events, product pack data, and master data to support government reporting. And many have products with requirements in other markets as well.

The top challenge, according to 45% of respondents, is building a flexible, reliable, and scalable infrastructure that will support these requirements. Of that group, 65% say serialization management is their biggest concern, and 35% say it’s supporting master data and compliance reporting infrastructure.

Another top concern is serialization readiness: 40% say supporting serialization for both internal packaging lines and external CMOs/CPOs is their biggest challenge. Another 15% are most concerned with preparing for EU FMD while also meeting other global regulations, such as DSCSA.

Your ability to build a full-scale serialization strategy for 2019 while maintaining business-as-usual operations hinges on your early preparation for serialization. If you’re still building your body of EU FMD knowledge—including requirements, planning strategy, and implementation— watch our on-demand webinar to understand: 

• Regulatory overview 
• Product and master data 
• Compliance reporting and verification 
• Partner and level 3 integration 
• The European hub 
• Questions from your peers, with answers from experts