To learn more about how PBM can help you register your drug products in Singapore, please contact us.
Introduction
An island nation of 5.4 million people, Singapore is considered one of the most developed pharmaceutical hubs in Asia. With its current market size of about $13 billion, the Singapore pharmaceutical market is expected to grow by 6.8% through 2028. The pharmaceutical sector in Singapore has experienced significant growth due to its sophisticated pharmaceutical infrastructure, highly-skilled workforce, and supportive government initiatives.
Health Authority
The Health Sciences Authority (HSA) is Singapore’s primary regulatory body overseeing medical products. Established on 1 April 2001, it resulted from the integration of five specialized agencies: the Centre for Drug Evaluation, the National Pharmaceutical Administration, the Product Regulation Department, the Institute of Science and Forensic Medicine, and the Singapore Blood Transfusion Service.
The HSA’s main responsibility is enforcing the Health Products Act (HPA), which governs Western medicines (therapeutic products) in Singapore.
Classification
In Singapore, pharmaceutical drugs are categorized into three primary classifications:
- Prescription-only medicines (POMs): These medications can only be acquired with a prescription from a doctor or dentist. A pharmacist can dispense them upon receiving a prescription from a doctor or dentist. POMs are used for diseases that require diagnosis and treatment by a qualified healthcare professional due to potentially serious side effects that may need to be monitored by the doctor.
- Pharmacy-only medicines (P): These medicines are available from retail pharmacies. Typically, patients with self-recovering conditions (conditions that be resolved without treatment) can seek these medications, and pharmacists working at these pharmacies are qualified to assess whether the medicines are appropriate for use. To make sure the medicines are used appropriately, pharmacists are required to maintain records of the sale of P medicines over the counter
- General sale list (GSL): these drugs can be purchased freely without any restrictions from any retailer since they are deemed safe for use by the general public and do not require medical monitoring for their use.
Registration application
Before registering your therapeutic drug product, it is essential to consider the following:
- Identify the appropriate application type:
– New drug application (NDA) options: NDA-1, NDA-2, NDA-3.
– Generic drug application (GDA) options: GDA-1, GDA-2.
- Decide on the evaluation route:
– Full evaluation (for NDA only).
– Abridged evaluation.
– Verification evaluation.
- Choose an application dossier format. You may select one of the following formats:
– International Council for Harmonization Common Technical Document (ICH CTD).
– ASEAN Common Technical Document (ACTD).
Summary of the Registration Process
The registration process entails several crucial preparatory steps. Adhering to the relevant guidelines is critical because the application fees are non-refundable if the dossier is rejected because of deficiencies. To ensure compliance, applicants are encouraged to seek consultation with the HSA.
Step 1: Pre-Submission Preparations:
Compile all necessary documents for the application dossier and consider seeking guidance from the HSA by submitting inquiries or attending consultation sessions.
Step 2: Application Submission:
Complete the application form on the Pharmaceutical Regulatory and Information System (PRISM) online platform and submit the complete dossier to the HSA within 2 business days of the submission of the PRISM application form.
Step 3: Application Screening:
The HSA will screen the application to see if all required documents have been provided, and the applicant must respond to any information requests from the HSA within 20 business days. Failure to do so will lead to the rejection of the application.
Step 4: Application Evaluation and Decision:
Once the application is considered complete, and requests for information are fulfilled, the HSA will evaluate the application and make a decision.
Timelines
The processing timelines for the HSA’s decision vary depending on the type of evaluation dossier:
– 270 working days for full evaluation dossiers
– 120-240 working days for abridged evaluation dossiers
– 60-120 working days for verification evaluation dossiers
However, these timelines may be longer if the HSA requires additional information from the applicant.
If the application is for an urgently-needed drug product for the treatment of life-threatening diseases, the timelines above will be reduced thanks to the priority review route.
To learn more about how PBM can help you register your drug products in Singapore, please contact us.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.hsa.gov.sg/