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Health Sciences Authority
NEX2US Newsletters

NEX2US FLASH - Issue 03 | March 2017

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

1 March 2017

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INFO-BYTE 1

JANUARY 2017
CHANGE IN LEADERSHIP
The Health Products Regulation Group (HPRG) wishes to announce the appointment of Assoc Prof Chan Cheng Leng as Group Director, HPRG with effect from 01 January 2017.

INFO-BYTE 2

NOVEMBER 2016
REVISED REGISTRATION REQUIREMENTS FOR GENERICS
The Therapeutic Product Branch has revised the requirements supporting the registration of generic drugs, namely:

  1. Test products used in bioequivalence (BE) studies that are manufactured by different drug substance and/or drug product manufacturers can be accepted if supporting documentation are available to demonstrate comparability to the generic products that are to be marketed in Singapore.

  2. Companies are no longer required to conduct comparative dissolution studies (CDS) between test and reference products used in BE studies in three different pH media. CDS conducted in one pH medium will be sufficient.

  3. Companies are no longer required to conduct comparative dissolution studies (CDS) between the generic product proposed for registration and the corresponding strength of the Singapore reference product to support applications for product strengths other than the strength tested in the BE study.


These changes are effective from 01 November 2016 and aim to help stakeholders reduce the cost burden and turnaround time for their applications.

You may refer to our guidance for more information.

READ MORE



INFO-BYTE 3

MAY 2017
TRANSFER OF LISTED CHINESE PROPRIETARY MEDICINES (CPM) OWNERSHIP
The Complementary Health Products Branch will be introducing a streamlined process to facilitate the transfer of listed CPM ownership from one licensed dealer to another dealer when no change of manufacturer is involved. Under the new initiative, dealers could provide HSA with the list of products to be transferred instead of having to submit a new listing application for each affected product.

This change will be effected from May 2017 and more information will be available on the HSA website nearer the date of implementation.

INFO-BYTE 4

MAY 2017
HEALTH PRODUCTS REGULATORY CONFERENCE (HPRC) 2017
HSA is co-organising HPRC 2017 with the Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School from 18 – 19 May 2017. The theme of the conference is “Enabling Innovations Through Collaborations in Advancing Healthcare”, and aims to provide regulatory updates for various health products and a platform to discuss the impact of healthcare innovation.

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