The risk of medicinal product shortages is a growing concern due to the evolving nature of supply chains. Modern ‘just in time’ supply strategies, designed to enhance efficiency and reduce inventory costs, have introduced vulnerabilities when efficiency is valued over security of supply. With smaller batch sizes and fewer Active Pharmaceutical Ingredient (API) production sites globally, supply disruptions can have a significant impact.
Many countries now have national safety stock requirements for certain medicines, underlining the importance of reliable supply chains. While these measures aim to prevent shortages, they also add pressure to an already complex system. Smaller countries or those with a lower market priority often face a higher risk of shortages due to limited leverage with global manufacturers and marketing authorisation holders.
Careful planning and collaboration are essential to address these challenges. By taking a proactive approach, stakeholders across the pharmaceutical supply chain can work together to ensure that medicines remain available. Regulatory affairs can play a critical role in preventing medicinal product shortages by bridging the gap between pharmaceutical companies, health authorities and supply chain stakeholders.
To support these efforts, Medfiles has outlined key considerations and practices to help minimise the risk of shortages.
PRE-SUBMISSION CONSIDERATIONS TO PREVENT MEDICINE SHORTAGES
- Supply chain sites must be carefully selected based on quality, reliability, geography, etc. to minimise risk. More than one site should be authority approved for all critical functions such as finished product and API manufacturing and testing.
- Effect of shelf-life – longer shelf-life lowers the risk of shortages.
- Module 3 documentation prepared for the marketing authorisation application should not contain unnecessary details to reduce the need for later updates.
POST-APPROVAL CONSIDERATIONS TO PREVENT MEDICINE SHORTAGES
- Whatever the change, communication about the change needs to be clear and timely. Keep all stakeholders well informed, especially about timelines and what is required from each stakeholder.
- Plan implementation timelines so that they are not unnecessarily tight.
- Smooth process flow in packaging technology reduces the lead time of printed packaging materials, which reduces the risk of shortages.
- Ensure that the supply chain is resilient, reliable and efficient.
- When supply chain adjustments are needed, such as changing manufacturing sites or packaging configurations, carefully plan the changes and actions required, and ensure that the supporting documentation is of high quality.
- Consider if buffer stock needs to be reserved for the time before the change can be implemented.
- Avoid ‘just in time’ processes with low stock levels, as they can lead to unnecessary shortages and increased administrative burden from stock-out notifications.
- On the other hand, avoid maintaining unnecessarily high levels of stock, as this creates costs and increases the risk of product expiration.
- It is important to monitor the stock-out situation and the market shares of competitors. If another manufacturer of a substitutable medicinal product is in stock-out, there will be additional demand for your product. This can create challenges, especially if your market share is small.
- By analysing upcoming changes in regulatory requirements or market trends, regulatory teams can provide strategic advice to avoid disruption.
CONSIDERATIONS FOR ADDRESSING SPECIFIC SUPPLY CHAIN CHALLENGES
- Multi-country packages can provide an additional “buffer stock”, where a surplus in one country can fill the needs of another.
- Special permit procedures for unlicensed supply or exemption applications (to deliberately exempt from the conditions of the marketing authorisation) could be considered to bring an alternative medicinal product to market. Working closely with the regulatory affairs and quality teams may ensure that alternative products reach the market when shortages seem unavoidable.
- Medicines with narcotic status require special attention – they are often held in mandatory safety stock and import/export licence processes can take time and slow down the supply chain.
- Pay attention to product pricing. If a product is priced too low, it may be difficult to maintain product availability in that market if there is a global shortage.
By ensuring compliance, advocating flexibility and facilitating timely approvals, regulatory professionals can play an essential role in helping to maintain the uninterrupted availability of medicines across the EU.
Competent marketing authorisation maintenance ensures that your medicinal product remains compliant and available on the market. If you struggle with limited resources or specific expertise, Medfiles’ Regulatory Affairs team is happy to help. Our experienced team provides comprehensive marketing authorisation maintenance services for human and veterinary medicinal products. You can outsource the full maintenance of your product or only specific parts to us.
See also: What regulatory lifecycle activities must MAH manage after approval?
