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Health supplements

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Traditional medicines

Regulatory overview
Voluntary Notification of HS and TM
List of Notified HS and TM
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Report adverse events
Traditional medicinal materials
International collaboration

Chinese proprietary medicines

Regulatory overview
Product listing
Dealer's licensing and certification
Free Sale Certificate
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Report adverse events
Traditional medicinal materials
International collaboration
Fees and Turnaround time of Chinese Proprietary Medicines

Cosmetic products

Regulatory overview
Cosmetic product notification
ASEAN Cosmetic Directive
Good Manufacturing Practice certification for cosmetic products
Report adverse events
Fees and turnaround time

Tobacco regulation

Overview of tobacco control
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Report tobacco-related offences
Fees and turnaround time
Tobacco retailer educational video and quiz

CTGTP

Regulatory overview
Class 1 CTGTP notification
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Variation applications
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Report or recall defective products
Clinical trials
Product consultation
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Certificate of a Pharmaceutical Product
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Fees and turnaround time
Register of Class 2 CTGTP
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Bringing personal medications into Singapore

Regulations for bringing in personal medications
Check medication requirements
Apply for approval

Clinical trials

Regulatory overview
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Submit a CRM notification
Good Clinical Practice Inspections
Report adverse events
Innovation Office
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Guidance documents
Clinical Trials Register
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Controlled drugs and psychotropic substances

Controlled drugs
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Restricted substances
Fees and turnaround time

Poisons

Overview of Form A Poisons Licence
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Fees and turnaround time

Topical antiseptics

Regulatory overview
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Guidance for suppliers of hand sanitisers

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Register your device

Registration overview
Is it a medical device Tool
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Risk classification tool Tool
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Medical device grouping tool Tool
Grouping medical devices
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Priority Review Scheme
Special Access Routes

Dealer's licence

Apply for a licence
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Renew or cancel a licence
Good Distribution Practice for Medical Devices

Field Safety Corrective Action reporting

When to report
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Risk management

International collaboration

IMDRF
AMDC

Register your product

Registration overview
Registration guides for therapeutic products
Summary Reports of Benefit-Risk Assessment
Special Access Routes (SAR)
GMP conformity assessment of overseas manufacturers
Lot release for imported vaccines
Pre-submission Consultation Mechanisms

Apply for post-approval variation

Overview of variation application types
Major variation (MAV-1) application
Major variation (MAV-2) application
Minor variation (MIV) application
Minor variation (MIV) self-guided tool

Reclassify your product

Apply for reclassification
Preparations allowed as General Sale List
List of reclassified medicines

Dealer's licensing and certification

Overview of dealer's licences
Apply for a licence
Amend a licence
Renew or cancel a licence
Good Manufacturing Practice and Good Distribution Practice Standards
Certification of local dealers
Handling of Applications and Conduct of Inspections During COVID-19

Retail pharmacy licensing

Overview of retail pharmacy licence
Apply for a retail pharmacy licence
Amend a retail pharmacy licence
Renew or cancel a retail pharmacy licence
Compounding of therapeutic products
Supply GSLs via vending machines
Supply of registered therapeutic products through e-pharmacy

Clinical trials

Regulatory overview
New CTA or CTN submission
Subsequent submissions
Good Clinical Practice Inspections
Report adverse events
Product consultation
Conducting clinical trials
Clinical Trials Register
Clinical trials statistics

CPP and SLS

Certificate of a Pharmaceutical Product
Statement of Licensing Status

International collaboration

Access Consortium
ICH
ICMRA
NPRA
ASEAN Joint Assessment Procedure

Medicines quality and compliance monitoring

Nitrosamine impurities in medicines
Product Quality Surveillance for therapeutic products

Product listing

Apply for new product listing
Amend or cancel product listing
Transfer product listing
Responsibilities of a CPM dealer

Dealer's licensing and certification

Overview of dealer's licences
Apply for a Chinese Proprietary Medicine dealer's licence
Amend a Chinese Proprietary Medicine dealer's licence
Renew or cancel a licence
Good Manufacturing Practice and Good Distribution Practice
Certification of local dealers
Import for re-export of Chinese Proprietary Medicines
Handling of Applications and Conduct of Inspections During COVID-19

Cosmetic product notification

Submit notification and re-notification
Update or cancel notification

Tobacco licences

Tobacco retail licence
Tobacco import and wholesale licence

Register a Class 2 CTGTP

Registration overview
Registration guides for Class 2 CTGTP
Special Access Routes (SAR)
GMP conformity assessment of overseas manufacturers

Variation applications

Overview of variation applications
MAV -1 application
MIV-1 and MIV-2 applications

Dealer's licensing and certification

Overview of dealer's licences
Apply for a licence
Amend a licence
Renew or cancel a licence
Good Manufacturing Practice and Good Distribution Practice Standards
Certification of local dealers

Clinical trials

Regulatory overview
New CTA or CTN submission
Subsequent submissions
Good Clinical Practice Inspections
Report adverse events
Product consultation
Conducting clinical trials
Clinical Trials Register
Clinical trials statistics

CTA, CTN or CTC submissions

New CTA or CTN submission
New CTC submission
Subsequent submissions

Conducting clinical trials

Study staff
Sponsor
Informed consent
Investigational and auxiliary products
Investigator Site File
Template forms

Controlled drugs

Apply for a controlled drugs licence
Amend licence to wholesale or manufacture controlled drugs
Renew or cancel a licence

Therapeutic products

Access
ICH
ICMRA
NPRA
ASEAN Joint Assessment Procedure

Medical devices

IMDRF
AMDC

Complementary health products

Access
ASEAN TMHS

Articles

Details

Articles

Details

Grouping medical devices

Dental Grouping Terms (DGT)
Hearing aids
Immunohistochemistry (IHC) IVD reagents
Fluorescence in situ hybridisation (FISH) probes IVD
IVD analysers
In vitro fertilisation (IVF) media
Family
System
Group
Single
IVD Test Kit
IVD cluster

Registration guides

Class B full registration
Class B abridged registration
Class B immediate registration
Class C full registration
Class C abridged registration
Class C expedited registration
Class C immediate registration
Class D full registration
Class D abridged registration
Class D expedited registration
Class D with a registrable drug in a secondary role full registration
Class D with registrable drug in secondary role abridged registration

Special Access Routes

Import for re-export of unregistered devices
Unregistered devices for non-clinical purposes
Registered medical devices on consignment basis
Unregistered devices requested by qualified practitioners
Unregistered devices requested by licensed PHMC
Custom-made medical devices
Import of unregistered medical devices for exhibition
Import of unregistered pre-owned devices from maintenance/repair
PSAR for Supply of Emergency Medical Devices

Registration overview

Registration overview
Application types
Evaluation Routes
Screening and evaluation stages
Application dossier
Retain, cancel or transfer registrations

Registration guides for therapeutic products

New drug application
Generic drug application
Biosimilar product application
Submission of Drug Master File
Submission of Plasma Master File

Special Access Routes (SAR)

Import and supply of unregistered TP for patient's use
Import and supply of registered drug on consignment basis
Special consignment by a product registrant
Pandemic Special Access Route for Supply of Emergency TP
Special Access Route for Unauthorised COVID-19 Vaccines

Major variation (MAV-1) application

Overview of MAV-1 application
Full evaluation route for MAV-1 application
Abridged evaluation route for MAV-1 application
Verification evaluation route for MAV-1 application

Minor variation (MIV) application

Overview
Submit MIV applications

Certification of local dealers

Good Manufacturing Practice certificate for local manufacturers
Good Distribution Practice certificate for local dealers

Nitrosamine impurities in medicines

Nitrosamine impurities in medicines- List of medicines impacted

Certification of local dealers

Good Manufacturing Practice certificate for local manufacturers
Good Distribution Practice certificate for local dealers

Tobacco retail licence

Apply for a tobacco retail licence
Amend tobacco retail licence
Renew tobacco retail licence
Cancel tobacco retail licence

Tobacco import and wholesale licence

Apply for tobacco import and wholesale licence
Amend tobacco import and wholesale licence
Renew tobacco import and wholesale licence
Cancel tobacco import and wholesale licence

Registration overview

Registration process
Pre-submission consultation
Application submission and screening
Evaluation and regulatory decision
Retain, cancel or transfer registrations

Registration guides for Class 2 CTGTP

Full evaluation route
Abridged evaluation route

Special Access Routes (SAR)

Import and supply of unregistered Class 2 CTGTP
Import and supply of CTGTP on consignment basis

MAV -1 application

Full evaluation route
Abridged evaluation route

Certification of local dealers

Good Manufacturing Practice certificate for local manufacturers
Good Distribution Practice certificate for local dealers

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Consumer safety

How adverse event reporting can enhance the safety of medicines

7 Nov 2022

Consumer, Therapeutic Products, General safety, Therapeutic products (medicines)

How adverse event reporting can enhance the safety of medicines

Health Sciences Authority

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Last Updated 03 Sep 2019