Key Takeaways:
- Think two phases ahead in regulatory planning.
- Develop “phase-appropriate” but forward-compatible data.
- Monitor global regulatory changes actively.
At a recent roundtable titled “From Drug Product Development to Overcoming Regulatory Hurdles,” professionals from both industry and academia gathered to explore one of the most complex aspects of modern drug development: how to navigate the regulatory journey from discovery to commercialisation while maintaining speed, quality, and compliance.
The discussion, moderated informally among participants, focused on two interrelated themes:
- Regulatory lifecycle considerations, and
- Aligning product development with regulatory expectations.
The result was an open, insightful exchange that shed light on how companies—large and small—can anticipate regulatory demands, avoid common pitfalls, and sustain innovation in a fast-changing global environment.
1. Thinking Two Phases Ahead: Regulatory Foresight in Drug Development
A recurring message from participants was clear: regulatory thinking must begin far earlier than most teams assume.
In drug product development, it is tempting to focus only on immediate deliverables—formulating for preclinical studies, preparing for Phase I, or rushing to get an IND ready. But as several participants emphasized, regulatory decisions made early in development can have lasting consequences that affect later filings, manufacturing, and even post-approval changes.
“Even though you’re developing a Phase I formulation,” one attendee noted, “you should already be thinking about what you’ll need for Phase III. It’s not about doing everything now—it’s about planning your strategy two phases ahead.”
This forward-looking mindset ensures that data generated during early development remains relevant and usable later. For instance, stability studies, impurity profiles, and analytical method validations often need to evolve in sophistication as the molecule progresses. If those needs are not anticipated, companies may face expensive and time-consuming data gaps at the IND or NDA stage.
Participants from smaller biotech firms highlighted the particular difficulty of this approach. Limited resources and compressed timelines can make it challenging to balance innovation with long-term planning. One participant reflected on the tendency of start-ups to “run fast,” focusing only on immediate trial readiness—only to encounter regulatory feedback that forces unplanned studies or reformulations later.
The consensus: “phase-appropriate” development should not mean “short-sighted” development. Even if a company cannot execute every study early, it must at least have a roadmap for how those requirements will be addressed later.
2. The Global Regulatory Landscape: Navigating Divergent Expectations
The discussion took a global turn when participants from a South Africa University shared their experiences with the South African Health Products Regulatory Authority (SAHPRA).
SAHPRA, established as part of South Africa’s ongoing regulatory modernization, draws heavily from FDA and ICH frameworks. However, as attendees noted, the system still faces challenges typical of a young regulatory body: backlogs, frequent leadership changes, limited transparency, and inconsistent guidance.
“It’s not always clear what’s expected,” one academic researcher said. “You often have to know who to talk to, because the official documentation can be difficult to interpret or even find.”
Unlike the FDA’s well-established structure, SAHPRA’s processes can be slower and less predictable. While a new drug application (NDA) might take around 10 months to review in the U.S., participants noted that approvals in South Africa often take several years—a significant barrier to both local innovation and international collaboration.
A uniquely South African challenge is the regulation of complementary and traditional medicines, reflecting the country’s rich heritage of indigenous plant-based knowledge. These products often fall outside standard regulatory categories, creating further ambiguity. Although efforts are being made to integrate traditional knowledge within modern drug development, the lack of clear frameworks has slowed progress.
The conversation underscored that while harmonization with ICH standards is desirable, full implementation requires not just adopting documents but building regulatory capacity, infrastructure, and expertise. Participants observed that greater regional cooperation and clearer templates—akin to the ICH’s Common Technical Document (CTD)—could help SAHPRA evolve more efficiently.
3. Aligning Innovation with Regulatory Expectations
In the second part of the discussion, participants tackled the ongoing challenge of maintaining regulatory alignment without stifling innovation.
In regions governed by ICH, a web of quality and risk-based guidelines—ICH Q8 through Q12—defines how companies should design, assess, and manage their products throughout the lifecycle. Concepts like Quality by Design (QbD) and risk-based CMC strategy are intended to improve robustness and flexibility. Yet, as several attendees acknowledged, implementation is not always straightforward.
One industry participant explained that while their company fully supports QbD principles, they often find the FDA still prefers traditional process validation models during pivotal phases like PPQ (Process Performance Qualification). This dual expectation means that organizations must carefully balance innovation with regulatory conservatism.
To manage this, some companies have created regulatory intelligence teams—dedicated groups that monitor changes in global guidance, interpret implications, and communicate them internally to R&D, manufacturing, and quality teams.
“Regulatory intelligence isn’t optional anymore,” one participant emphasized. “It’s how we stay compliant and innovative at the same time.”
The key is adaptability. As new modalities like cell and gene therapies, mRNA platforms, and novel excipient systems emerge, regulatory frameworks are evolving rapidly. Teams that build flexibility and continuous learning into their development process are better positioned to respond without sacrificing speed.
4. The Academic Perspective: Ethics, Capacity, and Collaboration
Representatives from academic institutions offered a complementary view. While universities are rarely the primary sponsors of late-stage development, they face their own regulatory hurdles—particularly in ethics approval processes and administrative backlogs.
In South Africa, for example, obtaining clearance from both university ethics boards and national regulators can be a lengthy, multi-step process. These delays not only slow clinical initiation but can also discourage translational research—the bridge between lab discovery and clinical proof-of-concept.
The discussion highlighted the importance of collaboration between academia and industry, especially in emerging markets. By sharing regulatory insights and providing early exposure to compliance requirements, academic researchers can design studies that better align with eventual commercial needs.
5. Balancing Speed, Strategy, and Compliance
As the session concluded, participants reflected on how to maintain innovation speed without compromising quality or compliance.
A few key themes emerged:
- Regulatory foresight matters. Plan two phases ahead—even if you act one phase at a time.
- Regulatory intelligence is essential. Constantly monitor new guidances and adjust internal processes accordingly.
- Global alignment is uneven. Companies working internationally must account for region-specific nuances, especially in emerging markets.
- Collaboration drives progress. Industry, academia, and regulators all benefit from knowledge exchange.
- Flexibility ensures resilience. Regulatory frameworks will continue to evolve; organizations must evolve with them.
“The key isn’t to do everything early—it’s to think early,” one participant summarized. “If you plan for the next two phases, you can save yourself years later.”
6. Conclusion: Building a Smarter Regulatory Future
The roundtable made clear that navigating the regulatory landscape is not a linear path—it’s a lifecycle of strategy, adaptation, and foresight.
Drug development today demands not just scientific rigor, but also regulatory intelligence. Companies that anticipate requirements, understand global diversity, and integrate compliance into innovation will be best positioned to deliver new therapies efficiently and safely.
From South Africa to San Diego, the challenges differ—but the goal remains the same: bring better medicines to patients faster, without compromising quality or trust.
