The Latest on Biopharma Regulatory Trends
by Dr. Christelle Laot
October 4, 2016
Healthcare can seem like a complex portfolio consisting of various product-based segments: pharma, biotech, devices, consumables, equipment, diagnostics and clinical trials — each with its own transportation needs and regulatory requirements. But within these many categories, pharma and biotech (often referred to as biopharma) represent about two-thirds of the total healthcare market value and are similar in terms of transportation requirements. The below bullet points provide an overview of the transportation regulatory frameworks relevant to pharma and biotech. If you can understand the framework of these two categories you’ll understand almost two-thirds of the total market needs.
- Higher transportation standards
The publication of Good Distribution Practices (GDP) guidelines by many countries, regions, organizations and associations has raised transportation standards. GDP led to better logistics equipment and higher infrastructure levels. Temperature-sensitive products have certainly benefited the most from the request to control environments. Many robust qualified cold chain solutions incorporating validated packaging systems are now available in the marketplace. A great focus is placed on quality management and overall performance metrics.
- Risk-based mindset
Risk-based approaches are clearly emphasized in standards relevant to healthcare transportation. Recent examples include ISO 9001:2015 revised standard and the section of EU Good Manufacturing Practice (GMP) Annex 15 dealing with transportation risk assessment. Control tools created by regulators such as FDA PREDICT import clearance system and FDA surveillance GMP inspections are now targeting bad compliance actors based on risk score. Transportation providers are also applying risk management methods to develop cold chain solutions more strategically. Furthermore, they are investing in contingency plans, as demonstrated by the increased number of cold chain centers at airports.
- Patient safety and security, traceability
Transportation providers have been offering added services such as track-and-trace, monitoring, intervention, end-to-end visibility, reporting and near real-time information for years to address globalization issues. Providers are now speaking about control towers, chain of custody and security features. Biopharma shippers are indeed requesting value-added services and tools to comply with healthcare security laws such as the US Drug Supply Chain Security Act (DSCSA).
- Trade compliance
The complexity and changing nature of import/export regulations certainly limit access to and from emerging markets. Trade compliance teams filing customs paperwork need to remain up to date on latest import/export requirements to avoid supply chain shortages. Combination products (drug/device, biologic/device or drug/device/biologic) may be challenging to address on the regulatory side. The presence of temperature data loggers on biopharma shipments is sometimes required for imports of pharmaceutical products, as mandated for entry into Saudi Arabia for instance.
Good Importer Practices (GIP) guidelines are expected to appear next on the list of guidelines following GMP, GDP and Good Supply Practices (GSP). Interestingly, the GIP draft created by U.S. regulators in 2009 has never been finalized.
Dr. Christelle Laot joined FedEx Express in 2007 and is currently technical fellow in the FedEx healthcare industry vertical. In this role, she provides thought leadership, strategic direction and subject matter expertise for healthcare transportation. Prior to her work with FedEx, Dr. Laot held managerial positions in R&D, innovation and strategy at Bayer in Germany for about six years.
Dr. Laot obtained a PhD and MS in chemical engineering from Virginia Tech (USA), a Diplôme d’Ingénieur from UTC Compiègne (France), as well as an MBA from HEC Montreal (Canada).