About the Author: Mohammed Jobran
As Saudi Arabia’s drug regulations become more stringent and sophisticated every year, companies planning to introduce new products into the Saudi market should no longer initiate their work on the SFDA drug registration 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 project around the submission requirement. This practice will eventually result in high exposure to compliance risks, hence delay in product launch.
Experienced management would sense when their regulatory project lacks an efficient strategy, usually by noting growing regulatory difficulties down the registration road. The expected risks of a weak RegStrat vary from minor issues that cause repetitive additions to timelines and budget to major overlooked issues that might engender years of delay, inability to market, or profitability impact, let alone total abortion of projects with complete loss of investments.
Therefore, developing a solid RegStart for your product registration is essential to avoid the abovementioned complications. Also, you need to align your regulatory activities with the commercial objectives. Although breakthrough medicine, approved in reference countries, and rare disease drugs might enjoy SFDA’s priority review and facilitation, it is still axiomatic to establish a reliable RegStrat to utilise invaluable returns such as:
- Compliance assurance (pre- and post-marketing).
- Accurate business decisions
- Smooth market access
- Clear regulatory impact
- Sooner launch timelines
- Controlled budget
- Investment protection
At PharmaKnowl, we structure our RegStrat holistically to include all affecting factors. It is built specifically for the Saudi market with the flexibility to adopt different types of products. It is centred around the following elements:
- Company objectives
- Product Specifications
- Applicable Regulations
- Regulatory Intelligence
- Stakeholders Input
The RegStar document will eventually reflect the outcome of a 360 regulatory analysis of all files, entities, functions, and company activities. This includes the post-marketing phase. Its core should at least incorporate the following:
- Regulatory Compliance
- Risks & resolution methods
- Drug File Gap Analysis
- High cost & time-consuming requirements, such as Stability studies & bioequivalence.
- Entities Due Diligence (MAH & manufacturer GMP)
- Regulatory procedures
According to objectives and available data, what is the applicable procedure:- New or generic drug registration
- Orphan Drug Designation
- Breakthrough Medicine Designation
- Conditional Approval
- Priority registration
- SFDA verification and abridged registration
- GHC central drug registration
- etc.
- Regulatory Intelligence
Research similar cases, the regulatory environment, product classification, available alternatives, applicable procedures, prescription status, etc. - Pharmacovigilance: Obligations & budget.
- Commercial
- Primary pricing analysis and expectations
- Regulatory impact on tenders, reimbursement, and formulary listing.
- Permitted marketing modules
- Revision of supply routes
- Finance
- Life cycle management impact on profit margins
- Detailed regulatory budget setting
- Legal
- IP, patent, brand status
- Partners & Agreements
- Operational:
- Primary regulatory plan
- Regulatory project timelines
- A prioritised set of requirements
Out of the regulatory strategy, a regulatory plan with a straightforward course of action has to be generated and implemented within a regulatory project. It should include defined deliverables, timelines, task ownership, stakeholders, and implementation methods. Only then will it become a day-to-day regulatory operation mission.
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