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This application is a service of the Singapore Government.

Health Sciences Authority

Target Processing Timelines

target_processing_timelines

HPRG aims to approve licence applications and permits submitted through our e-services in a timely manner. You may access the following links to find out more about our target processing timelines.

*All timelines stated (in working days) are subject to change

Applications for Therapeutic Products

Screening timeline 25 working days before the first communication, in the form of an Input Request or acceptance/non-acceptance notification, is issued

Evaluation timeline

Dossier type

NDA

GDA

MAV-1

MAV-2

MIV-1

Full

270

 

270

   

Abridged

180

240

180

180

120

Verification

60

120

60

   

Verification – CECA

 

90

     

MIV-2 applications

Applicant can implement the proposed change(s) if HSA does not raise any objection within 40 working days from the date of submission of the complete dataset for the application.

For more information please refer to Appendix 5: Target Processing Timelines of the Guidance on Medicinal Product Registration.

 

Applications for Medical Devices

Risk Classification TAT for Registration (in working days)
Class A 30
Risk Classification TAT for Registration Routes (in working days)
  Immediate Expedited Abridged Full
Class B Immediate Registration upon Submission 60 100 160
Class C   120 160 220
Class D   180 220 310
Class D, devices incorporating registrable medicinal products     220 310

For more info, please refer to GN-15-R5 Guidance on Medical Device Product Registration (Updated on Dec 2012), page 43
 

Applications for Chinese Proprietary Medicines

Type 类型 No. of working days 工作日
New application 新申请 60
Amendment 变更申请 60

Click here for more information.
 

Applications for Clinical Trials

Application Type New Application Substantial Amendments Non-substantial Amendments
Clinical Trial Certificate (CTC)

30 working days

Note: 60 working days for cell and tissue products

15 working days 5 working days
Clinical Trial Authorisation (CTA)

30 working days

Note: 15 working days for some Phase 1 studies

15 working days 5 working days
Clinical Trial Notification (CTN) 5 working days 5 working days 5 working days
Clinical Research Materials Notification (CRM) Immediate Immediate

With effect from 1 November 2016

Click here for more information.
 

Certification/Licensing of Manufacturers and Dealers

Type of application Target Processing Timeline (excluding stop-clock time incurred by the applicant)
Good Distribution Practice (GDP) Certificate 10 working days from date of audit close out
Good Manufacturing Practice (GMP) Certificate 10 working days from date of audit close out
Free Sales Certificate (FSC) 10 working days
Statement of Licensing Status (SLS) 10 working days
Certificate of Pharmaceutical Product (CPP) 10 working days
Import Licence for Chinese Proprietary Medicines and Medicinal products 10 working days from date of audit close out
Wholesale dealers licence for Chinese Proprietary Medicines and Medicinal products 10 working days from date of audit close out
Manufacturer licence for Chinese Proprietary Medicines and Medicinal products 10 working days from date of audit close out
Form A Poisons Licence 10 working days from date of audit close out
Medical device dealers licences (including manufacturer, importer and wholesaler licences) 10 working days
Evaluation of medical device dealers licences with QMS-CAD submission 10 working days from date of audit close out


Retail Pharmacy Licence

Type of Application Target Processing Timeline
(working days, excluding stop-clock time)
Retail Pharmacy Licence 10 working days from date of audit close out

Click here for more information.
 

Psychotropics and Controlled Drugs

Type of Application Target Processing Timeline
(working days, excluding stop-clock time)
Export Licence for Psychotropic Substances 10 working days
Authorisation to import Psychotropic / Restricted Substances 10 working days
Licence to sell controlled drugs by wholesale 10 working days from date of audit close out
Licence to manufacture controlled drugs 10 working days from date of audit close out
Licence to import/export controlled drugs 20 working days

Click here for more information.

Applications for Medical Advertisement and Sales Promotion Permit

Type of Application Target Processing Timeline
(working days, excluding stop-clock time)
Application for Medical Advertisement and Sales Promotion Permit 14
Amendment for Medical Advertisement and Sales Promotion Permit 14

Click here for more information.