NEX2US Newsletters

NEX2US FLASH - Issue 05 | April 2018

Audiences

Healthcare professional

Industry member

Product type

Cell, Tissue and Gene Therapy Products

Chinese Proprietary Medicines

Controlled drugs

Cosmetic products

Health supplements

Homeopathic medicines

Medical devices

Psychotropic substances and poisons

Therapeutic Products

Tobacco control

Traditional medicines

3 January 2018

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Supporting Innovation

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APRIL 2018 INNOVATION OFFICE, MEDICAL DEVICES CLUSTER, ADVANCED THERAPY PRODUCTS BRANCH	HSA has set up an Innovation Office as a pilot to support the development of novel and innovative therapeutic products in Singapore. The Office will provide scientific and regulatory advice to researchers, academia, biotech and pharmaceutical companies with an interest in early stage clinical product development, to facilitate the pursuit of product registration in Singapore. For more information, please click here. A Medical Devices Cluster has been established to serve as a one-stop centre to provide for a holistic life cycle approach in the regulation of medical devices. Medical device dealers will now have a single interface through this cluster to perform all their registration, licensing and post marketing activities including change notification, post market information reporting on product defects and product complaints. The Advanced Therapy Products Branch is formed in tandem with the increasing research and development in cell, tissue and gene therapy products. HSA is in the process of putting in place a forward looking regulatory framework to provide clarity and to guide the development and registration of this emerging group of health products.
OCTOBER 2017 MEDICAL DEVICE PRE-MARKET CONSULTATION SCHEME	The medical device Pre-market Consultation scheme was introduced at different stages of the medical device lifecycle, namely, the Product Development stage and Pre-market Submission stage to support product development and registration. This upstream consultation will enable regulatory considerations to be incorporated at the design and conceptual phase which is envisioned to help ensure a smooth and efficient downstream product registration.
AUGUST 2017 TELEHEALTH GUIDANCE	In tandem with the rapid pace of innovations in Telehealth technology and to support Singapore’s Smart Nation initiative, the Telehealth Guidelines was published in 2017 to provide clarity on the types of Telehealth devices that are subjected to HSA’s regulatory control. This is aimed to provide guidance to industry and promote innovation in this area.

APRIL 2018

INNOVATION OFFICE, MEDICAL DEVICES CLUSTER, ADVANCED THERAPY PRODUCTS BRANCH

HSA has set up an Innovation Office as a pilot to support the development of novel and innovative therapeutic products in Singapore. The Office will provide scientific and regulatory advice to researchers, academia, biotech and pharmaceutical companies with an interest in early stage clinical product development, to facilitate the pursuit of product registration in Singapore. For more information, please click here.

A Medical Devices Cluster has been established to serve as a one-stop centre to provide for a holistic life cycle approach in the regulation of medical devices. Medical device dealers will now have a single interface through this cluster to perform all their registration, licensing and post marketing activities including change notification, post market information reporting on product defects and product complaints.

The Advanced Therapy Products Branch is formed in tandem with the increasing research and development in cell, tissue and gene therapy products. HSA is in the process of putting in place a forward looking regulatory framework to provide clarity and to guide the development and registration of this emerging group of health products.

OCTOBER 2017

MEDICAL DEVICE PRE-MARKET CONSULTATION SCHEME

The medical device Pre-market Consultation scheme was introduced at different stages of the medical device lifecycle, namely, the Product Development stage and Pre-market Submission stage to support product development and registration.

This upstream consultation will enable regulatory considerations to be incorporated at the design and conceptual phase which is envisioned to help ensure a smooth and efficient downstream product registration.

AUGUST 2017

TELEHEALTH GUIDANCE

In tandem with the rapid pace of innovations in Telehealth technology and to support Singapore’s Smart Nation initiative, the Telehealth Guidelines was published in 2017 to provide clarity on the types of Telehealth devices that are subjected to HSA’s regulatory control. This is aimed to provide guidance to industry and promote innovation in this area.

Facilitating Access to Health Products

Table caption

UPCOMING IN 2018 ENHANCING ACCESS TO SAFE AND EFFECTIVE MEDICAL DEVICES THROUGH SIMPLICFICATION OF PRODUCT APPLICATIONS	HSA will be simplifying the following registrations to further enhance access of low to moderate risk medical devices: All Class A medical devices (including sterile) will be exempted from product registration; Immediate route for Class B medical devices with relevant approvals from reference regulatory agencies and safe marketing history. Both measures are targeted for implementation on 1 June 2018 and will benefit the stakeholders in expediting market access. Post-market compliance monitoring will be strengthened to maintain the safety and quality of these lower risk medical devices.
APRIL 2017 IMPLEMENTATION OF OVERALL SCREENING TURNAROUND TIME (TAT) FOR THERAPEUTIC PRODUCTS	To improve predictability of screening time for applications, an overall screening TAT of 50 working days was introduced for the following application types: New drug applications (NDA) Generic drug applications (GDA) Major variation applications (MAV) The TAT starts from the date of receipt of the application dossier and ends on the date of acceptance or non-acceptance/withdrawal of the application, excluding stop-clock.
DECEMBER 2017 IMPLEMENTATION OF VERIFICATION ROUTE FOR MINOR VARIATION TYPE 1 (MIV-1) APPLICATION FOR THERAPEUTIC PRODUCTS	This route was implemented to provide a shorter processing timeline of 90 working days as compared to the abridged route with a timeline of 120 working days. This enhancement further improves process efficiency through leveraging assessments done by HSA’s reference agencies, thereby minimising the duplication of efforts.
AUGUST 2017 PRIORITY REVIEW SCHEME FOR MEDICAL DEVICES TO FACILITATE INNOVATION AND TECHNOLOGY DEVELOPMENT	The Priority Review Scheme was launched to facilitate faster access to innovative medical devices, particularly the devices for unmet clinical needs. With this initiative, there will be up to 25% reduction in TAT for medical device applications under priority review. This further strengthens Singapore role as a preferred launch pad for new and innovative devices.
APRIL 2017 SIMPLIFICATION OF COSMETIC PRODUCTS NOTIFICATION FORM	With effect from 25 April 2017, the online notification form for cosmetics products has been simplified. Information needed for product traceability will still be required for the notification, while other information relating to product supply, safety and technical aspects are to be submitted only upon request by HSA.

UPCOMING IN 2018

ENHANCING ACCESS TO SAFE AND EFFECTIVE MEDICAL DEVICES THROUGH SIMPLICFICATION OF PRODUCT APPLICATIONS

HSA will be simplifying the following registrations to further enhance access of low to moderate risk medical devices:

All Class A medical devices (including sterile) will be exempted from product registration;
Immediate route for Class B medical devices with relevant approvals from reference regulatory agencies and safe marketing history.

Both measures are targeted for implementation on 1 June 2018 and will benefit the stakeholders in expediting market access.

Post-market compliance monitoring will be strengthened to maintain the safety and quality of these lower risk medical devices.

APRIL 2017

IMPLEMENTATION OF OVERALL SCREENING TURNAROUND TIME (TAT) FOR THERAPEUTIC PRODUCTS

To improve predictability of screening time for applications, an overall screening TAT of 50 working days was introduced for the following application types:

New drug applications (NDA)
Generic drug applications (GDA)
Major variation applications (MAV)

The TAT starts from the date of receipt of the application dossier and ends on the date of acceptance or non-acceptance/withdrawal of the application, excluding stop-clock.

DECEMBER 2017

IMPLEMENTATION OF VERIFICATION ROUTE FOR MINOR VARIATION TYPE 1 (MIV-1) APPLICATION FOR THERAPEUTIC PRODUCTS

This route was implemented to provide a shorter processing timeline of 90 working days as compared to the abridged route with a timeline of 120 working days. This enhancement further improves process efficiency through leveraging assessments done by HSA’s reference agencies, thereby minimising the duplication of efforts.

AUGUST 2017

PRIORITY REVIEW SCHEME FOR MEDICAL DEVICES TO FACILITATE INNOVATION AND TECHNOLOGY DEVELOPMENT

The Priority Review Scheme was launched to facilitate faster access to innovative medical devices, particularly the devices for unmet clinical needs.

With this initiative, there will be up to 25% reduction in TAT for medical device applications under priority review. This further strengthens Singapore role as a preferred launch pad for new and innovative devices.

APRIL 2017

SIMPLIFICATION OF COSMETIC PRODUCTS NOTIFICATION FORM

With effect from 25 April 2017, the online notification form for cosmetics products has been simplified. Information needed for product traceability will still be required for the notification, while other information relating to product supply, safety and technical aspects are to be submitted only upon request by HSA.

Government officials will never ask you to transfer money or disclose bank log-in details over a phone call.

NEX2US FLASH - Issue 05 | April 2018

Supporting Innovation

Facilitating Access to Health Products

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