Reference: Health Sciences Authority – Special Access Route
Post comment: YK Png. Freelance Regulatory Affairs Pharmacist
Singapore’s healthcare system prioritizes safety and efficacy, ensuring that medications used are officially registered. However, situations arise when a registered alternative is not available for a patient’s critical needs. The Special Access Route (SAR) addresses this gap.
What is the SAR?
The SAR allows licensed healthcare institutions in Singapore, including hospitals, clinics, or pharmacies, to import unregistered drugs for named patients with no registered alternatives. This provides a vital option for patients who might otherwise have limited treatment choices.
Who Can Apply?
- Licensed Hospitals: Both public and private hospitals.
- Licensed Clinics: Private specialist or group clinics with qualified doctors.
- Licensed Retail Pharmacies: Pharmacies can apply on behalf of patients, provided they have a valid prescription from a registered doctor or dentist in Singapore.
Detailed Application Requirements:
- Completed Online Form: Accessible via Corppass, the online form requires detailed information about the patient, the specific unregistered drug, and the justification for its use.
- Patient Medical Records: Comprehensive medical records documenting the patient’s condition and the lack of registered alternatives are crucial.
- Justification Letter from Doctor: A detailed letter from the prescribing doctor outlining the medical rationale for using the unregistered drug.
- Product Information: Provide comprehensive information about the unregistered drug, including its composition, safety profile, and clinical data if available.
Turnaround Time and Fees:
- Turnaround Time: The processing time for SAR applications by the Health Sciences Authority (HSA) is not publicly available, but it typically takes several weeks for a decision.
- Fees: There are currently no application fees associated with submitting an SAR request to the HSA.
Additional Information to Consider:
- Risk Management and Safety Monitoring:
- Post-Approval Monitoring: Ensure ongoing monitoring of the patient’s response to the unregistered drug, documenting any adverse effects.
- Risk Mitigation Plans: Develop a comprehensive risk mitigation strategy to manage potential safety concerns associated with the use of unregistered drugs.
- Regulatory Compliance:
- Adherence to HSA Guidelines: Ensure all documentation and procedures strictly adhere to HSA guidelines to avoid delays or rejections.
- Regular Updates: Stay updated on any changes in SAR regulations or procedures to ensure continued compliance.
- Case Studies and Success Stories:
- Real-Life Examples: Highlight successful cases where the SAR has significantly benefited patients, providing practical insights into the process.
- Expert Insights: Include interviews or quotes from healthcare professionals who have navigated the SAR process successfully.
How can CoachToring.Com help?
Our regulatory experts can guide you through every step of the SAR process:
- Eligibility Assessment: We’ll meticulously evaluate your patient’s case to determine SAR program applicability.
- Application Support: We’ll help you navigate the online portal and compile a comprehensive application package for the HSA.
- Local Partnerships: We can connect you with qualified healthcare providers in Singapore familiar with the SAR process.
- Regulatory Updates: We’ll keep you informed about any changes in Singapore’s regulations that might impact your application.
Contact
CoachToring.Com Regulatory Affairs Service Provider today and let’s explore the possibilities together!
