As drug regulations in Saudi Arabia become more stringent and sophisticated each year, biotech and pharmaceutical companies planning to introduce new products to the Saudi market should begin their SFDA drug registration project by developing a robust regulatory affairs strategy (RA Strategy).

The concept of RA Strategy is known by most, mastered by a few. We encounter many who apply the “fix it on the road” strategy, leading to repeated mistakes. Others might even head into the unknown by pivoting their project around the availability of the submission requirements. Such practices ultimately result in high exposure to risk, the least of which is a delayed product launch.

Executive managers would sense when their regulatory project lacks an efficient strategy, typically by noting growing regulatory difficulties along the registration path. The expected risks of a weak RA Strategy range from minor issues that cause repeated additions to timelines and budgets to major, overlooked issues that might engender years of delay, inability to market, or profitability impacts, let alone the total abandonment of projects with complete loss of investment.

Therefore, developing a solid RA Strategy for your product registration is essential to avoid the abovementioned complications. Also, you need to align your regulatory activities with the commercial objectives. Even if your product is eligible for accelerated pathways or designations, it is still axiomatic to establish a reliable RA Strategy to utilize invaluable returns such as:

Accurate business decisions
Compliance assurance.
Smoother market access
Measured regulatory impact
Shorter launch timelines
Controlled budget
Investment protection

At PharmaKnowl, we structure our RA Strategy holistically to include all factors that affect it. It is built specifically for the Saudi market with the flexibility to adopt different types of products, centered around the following elements:

Company objectives
Product Specifications
Applicable Regulations
Regulatory Intelligence
Stakeholders Input

The RA Strategy document will ultimately reflect the outcome of a comprehensive 360-degree regulatory analysis of entities, assets, functions, and marketing phases. Its core should at least incorporate the following:

Regulatory Compliance
- Risks & resolution methods
- Entity Due Diligence (MAH & manufacturer GMP)
- Drug File Gap Analysis
- High-cost and time-consuming requirements, such as clinical trials, stability studies & bioequivalence.
- Applicable Regulatory Procedures
  - New drug, biological, ATMP, biosimilar, or generic application.
  - Orphan Drug Designation
  - Breakthrough Medicine Designation
  - Priority Review Registration
  - Verification and abridged registration
  - Special Access Program (SAP)
  - The SFDA Accelerated Program for Rare Disease Drugs (NADR)
  - RAID Designation: SFDA Incentives for Local Clinical Trials
  - GHC central drug registration
  - etc.
Regulatory Intelligence
Researching similar cases, the regulatory environment, product classification, alternative therapies, the prescribing legal status, and other relevant factors.
Post-marketing Obligations
- For example, pharmacovigilance considerations & budget.
- Clinical Research (Phase IV, PASS)
- Conditional Approval data Obligations
Commercial
- Primary pricing analysis and expectations
- Regulatory impact on tenders, reimbursement, and formulary listing.
- Permitted marketing models
- Revision of supply routes
Finance
- Detailed regulatory budget setting
- Life cycle management impact on profit margins, such as changing manufacturers or MA holders.
Legal
- IP, patent, brand status
- Partners & Agreements
Operational
- Primary regulatory plan
- Regulatory project timelines
- Prioritized set of requirements

Within the regulatory strategy, a regulatory plan with a course of action needs to be generated and implemented as part of a regulatory project (Strategy>Plan>Project). The project should include defined deliverables, timelines, task ownership, stakeholders, and implementation methods. Only then will it become a day-to-day regulatory operations mission.

Categories: ArticlesTags: Biotech, Pharma

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