As the drug regulations in Saudi Arabia become more stringent and sophisticated every year, companies planning to introduce new products into the Saudi market should no longer commence with the SFDA requirements without developing a robust regulatory strategy (RegStrat).
The concept of RegStrat is generally known and mastered by big firms, however, many still tend to initiate their regulatory projects based on repeated strategies. Others might even head to the unknown by pivoting their whole new access project around the submission requirement. This type of practice will eventually result in high exposure to compliance and commercial risks
ِAn experienced management would clearly sense when their regulatory project is lacking an efficient strategy. This is by noting many unexpected regulatory difficulties down the road of implementation. The expected risks of a weak RegStrat may vary from minor issues, that causes repetitive additions to timelines and budget, to major overlooked issues that might engender years of delay, inability to market, or profitability impact. Let alone abortion of projects with complete loss of investments.
Therefore, it is essential to develop a solid RegStart for product registration projects to avoid mentioned complications and to align the regulatory activities with the main business strategy. Although a breakthrough innovative drugs might enjoy SFDA’s priority and facilitation, it is still axiomatic to establish a reliable RegStrat to utilize invaluable returns such as:
- Compliance assurance (Pre/post-marketing).
- Accurate business decisions
- Confirmed market accessibility
- Clarity on all aspects of regulatory impact
- Minimum project timelines
- Controlled budget
- Avoiding bad investments
At PharmaKnowl, we structured our RegStrat document in a holistic approach to include all affecting factors. It is built specifically for the Saudi market with the flexibility to adopt different types of products. Basically, it is centered around the following elements:
- Product Specifications
- Applicable SFDA Regulations
- Regulatory Intelligence
- Company objectives
- Input of internal & external stakeholders
The RegStar document will eventually reflect the outcome of a 360 regulatory analysis on all files, entities, functions, and company activities. This is including the post-marketing phase. Its core should at least incorporate the following:
- Regulatory Compliance
- Risks & resolution methods
- Gap analysis & due diligence
- Regulatory Intelligence
- E.g., research similar cases, regulatory environment, product classification, applicable procedures, prescription status,..etc
- Primary pricing analysis and expected schemes
- Regulatory impact on tenders, reimbursement, and formulary listing.
- Permitted marketing modules
- Revision of supply routes
- Regulatory impact on profit margins
- Detailed regulatory budget setting
- IP, patent, brand status
- Partners & Agreements
- Primary regulatory plan
- Regulatory project timelines
- A prioritized set of requirements
Out of the regulatory strategy, a regulatory plan with a clear course of actions has to be generated and implemented within a regulatory project with defined deliverables, timelines, tasks’ ownership, stakeholders, and methods of implementation. Only then it becomes a day to day regulatory operation.