Developing a global regulatory strategy for a new drug means planning early for the markets you want to enter. It involves gathering the evidence each region expects and the submission sequence to reduce delays.
A strong regulatory strategy covers:
- clinical,
- CMC,
- pharmacovigilance, and
- commercial plans.
Hence, the product can move from development to approval with fewer surprises.
Portfolio Planning & Lifecycle Management
Start with the target product profile and the likely label claims. That helps define:
- the data package,
- the development plan, and
- the future drug lifecycle management path, including new indications, line extensions, and post-approval changes
A strategy document should cover development milestones, key risks, scientific advice opportunities, and long-term maintenance post-approval.
Selection of Markets and Submission Pathways
Selecting markets and submission pathways is critical while developing new drugs. They should be chosen based on:
- patient need,
- commercial potential, and
- regulatory complexity
Later on, for each selected region, organizations should map the regulatory pathway selection. It spans filing requirements in the region, accelerated (expedited) pathways (where available), and, most importantly, the timelines for global submissions.
For a new drug, the sequence often begins with nonclinical planning, then IND or clinical trial applications, and finally NDA or MAA-style submissions, depending on the country. A well-designed drug development strategy also considers whether the product is a small molecule or biologic, because the biologic approval process can require different comparability, manufacturing, and potency data.
Aligning Teams
Avoid isolated development of regulatory strategies. Strategizing aligns perfectly when teams (such as regulatory, clinical, safety, CMS, and scientific writing) collaborate and plan together. Â The collaboration supports and enhances the development of clean, accurate dossiers. It avoids gaps between modules and improves the quality of strategic decisions pertaining to CMC regulatory strategy.
Planning should also include post-launch pharmacovigilance to strengthen the regulatory strategy. It should be involved early so that safety surveillance, signal management, and post-marketing commitments are planned accurately and bring in a strong support system for regulatory compliance requirements after launch.
Common Challenges
In a big pharma company, the common problem to address is the lack of unified processes. The ununified processes across different markets and multiple teams operating from various locations result in inconsistent data packages and late decisions regarding manufacturing or label claims, especially in a volatile environment of rapidly changing regional requirements.
Amid all these challenges, creating a foolproof submission matrix with well-defined milestones, team dependencies with ownership responsibilities, regional risks, and remedies, makes a practical solution. It makes the new drug approval process manageable and directs the team to focus on evidence that supports multiple markets. According to reports, 54% of biotech and pharmaceutical companies outsource their regulatory operations to achieve compliance during new drug development.