While expansion into new markets potentially introduces tremendous opportunities to scale your business, globalizing your development program doesn’t come without risks. Whether you’re a pharma or biotech from an established region looking to expand into an emerging market, or you’re looking to expand from a smaller, emerging region into a more established, mature market, expansion introduces new challenges with regulatory compliance and data integrity.
We recently sat down with regulatory industry expert, Lawrence Liberti, Head of Regulatory Collaborations at the Centre for Innovation in Regulatory Science, to hear his advice and practical tips on managing regulatory challenges while ensuring data quality and product integrity.
Why is it important to establish collaborative relationship with local regulatory bodies before expanding into a new market?
Liberti: Regardless of whether you’re expanding into a new market through your own affiliate or by licensing services, it’s important to make sure all your systems, processes, and procedures are adapted based on local requirements. Different countries have very specific clinical trial and data requirements. Do you have the required knowledge of data and regulatory expectations in those countries to successfully submit for market authorization? Many organizations don’t realize that you can petition country regulators for scientific advice, helping ensure success throughout your development lifecycle.
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What mistakes have you seen organizations make in terms of not understanding inspection and stability requirements across markets?
Liberti: Many organizations underestimate the financial and resource-related burdens that can stem each new market requiring a separate facility inspection and product verification. Some markets are open to negotiating and leveraging previous inspection results to satisfy their requirements. You also need to understand whether your new markets restrict submission until the product has been proven stable. Again, this is where collaborating with local regulatory bodies for scientific advice can greatly streamline these processes.
No one wants to be on the receiving end of an inspection enforcement pointing to quality control issues or discrepancies in your methods, facilities, or controls. Quality issues are especially challenging in emerging markets – not all production lines and facilities are GMP compliant. I recommend organizations confirm the proper manpower to manage inspect requests before submitting for market authorization.
Why is it important to understand reimbursement policies in your countries of origin?
Liberti: You can expect to face tough negotiations from insurers, payment and healthcare plans, and health technology assessment (HTA) bodies when expanding across multiple global markets. Preparing for payer fragmentation and negotiating requires a great deal of manpower and expertise. Engaging early with regulators and HTA bodies can save a great deal of time and resources when submitting for reimbursements.
Why are cloud-based repositories a good option to protect your intellectual property?
Liberti: I definitely recognize the use of cloud-based repositories as the wave of the future in terms of protecting trade secrets and IP. Cloud-based submissions allow you to securely upload your complete data and documentation set, including things like your post-authorization activity results, adverse events reports, and effectiveness reporting. You can basically pick and choose what information you want to share with which countries. Ultimately, this kind of access is going to speed your submission review process.
How can organizations ensure patients are receiving genuine products throughout a trial?
Liberti: There are over 50 global markets that require some sort of traceability requirements to ensure patients receive genuine products. Track-and-trace requirements ensure quality and compliance by authenticating, monitoring, and controlling the flow of drugs. These requirements ensure everything from labeling and packaging to distribution and returns processing are compliant with track-and-trace.
Are you expanding into an emerging market or into a more established, mature market?
Regardless of your expansion scenario, it’s important to manage regulatory compliance and data integrity challenges using the proper resources that ensure you’re referencing the most up-to-date information.
If you’re ready to level the playing field and improve your chances of success when submitting for regulatory approval, stick to these 5 quick tips:
- Establish collaborative relationships
- Understand inspection and stability requirements
- Vet reimbursement policies
- Protect IP in cloud-based repository
- Develop track-and-trace requirements
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