NEX2US FLASH - Issue 06 | February 2019

January 2019

HSA has further streamlined our application processes and requirements to facilitate filing of applications. The key enhancements which are implemented from 15 January 2019 are highlighted below:

• Introduction of ‘Do-and-Tell’ initiative for minor variation MIV-2 application which allows companies to implement minor administrative changes without prior approval. Companies may bundle all changes effected and notify HSA via a single MIV-2 application within 6 months of implementation.
• Re-categorisation from major variation application MAV-1 to minor variation MIV-1 for post-approval inclusion of clinical information on the concomitant administration of vaccines in the product label.
• Re-categorisation from minor variation MIV-1 to MIV-2 for other variations, such as addition or amendment to the “Drug Interactions” and “Overdose” sections of the package inserts that strengthens safety information or restriction of use.
• The MIV checklist has also been enhanced for further clarity in submission requirements.

Details on the enhancements are available at this link.

January 2018

The CHP Classification Tool was developed to provide guidance and quick access to information for dealers to determine the classification of typical CHP based on product ingredients and intended purposes. This tool has been introduced on our website in November 2018.

Click here for more information.

September 2019

HSA will be revising the heavy metal limits for CHP. The revised limits will be implemented on 1 September 2019 for new products, and on 1 September 2020 for existing products in the market.

With the revision, Singapore’s limits will be aligned with those set by the World Health Organisation (WHO) and ASEAN. This enhances consumer protection, and at the same time facilitate companies’ entry into other markets through compliance with international standards.

Click here for more information

November 2018

HSA has lifted the ban on Corydalis yanhusuo (延胡索) herb and THP-containing herbs following an extensive review. The ban was implemented in 1995 following overseas reports that THP could cause liver toxicity when consumed.

From 1 June 2018, the import and sale of Corydalis yanhusuo herb and CPM containing the naturally occurring substance THP are allowed in Singapore.

Appropriate safeguards have been introduced to ensure the safety of these products. This includes reviewing the safety and quality of CPM containing these herbs before they are placed in the local market, limiting the daily intake of THP at a low level of 19 mg, and additional labelling requirements to include cautionary statements for such products.

Companies may now introduce these CPM in their original formula without the need to reformulate specifically for the Singapore market. It would also facilitate access to more treatment options for our local Traditional Chinese Medicine (TCM) practitioners and patients.

Click here for more information.

January 2018 - January 2019

From 1 January 2019, Switzerland's SwissMedic has recognised HSA as having a comparable control system for medicinal products. Australia's TGA has also listed HSA as a Comparable Overseas Regulator (COR) for prescription medicines since 2 January 2018.

With these listing, companies that are interested in entering the Swiss and Australian markets can potentially benefit from shorter processing timelines if their medicinal products had already been registered in Singapore.

Click on the links to access SwissMedic and TGA websites.

HSA is part of the ACSS consortium, in collaboration with TGA, Health Canada and SwissMedic.

The Consortium is actively pursuing innovative work sharing models to enhance efficiencies in the registration process and to promote regulatory convergence of technical data requirements. The work sharing pilot is available for the following types of applications that have been filed with at least two ACSS agencies:

• Chemical or biological entity
• Generic medicines

We would like to encourage applicants who are interested in the work sharing pilot to get in touch with us.

Click here for more information.

July - October 2018

UMC was established since 1978 to support WHO Programme for International Drug Monitoring. Its mission is to promote patient safety through effective and global pharmacovigilance practice.

As part of their 40th anniversary celebrations, UMC has produced a documentary film on global medicines safety titled “Going Further Together”. Singapore was one of the five countries featured. In the film, HSA shared on new innovations that help strengthen patient safety. We were also featured in the UMC’s 40th anniversary publication of their Uppsala report under the section on “The Future of Pharmacovigilance”.

Click on the links to view the publication.

4th WHO-UMC-HSA Inter-Regional Pharmacovigilance Training Workshop

HSA partnered WHO and UMC to co-organise the 4th Inter-Regional Pharmacovigilance Training Workshop with Duke-NUS Centre of Regulatory Excellence (CoRE) in August 2018. With the theme “Partnerships to Protect Public Health”, this workshop was extended to industry participants for the first time. This provided an opportunity for regulators and industry to explore further collaboration that strengthens drug safety and enhance pharmacovigilance capabilities in the region.

June 2018

HSA was elected as a member of the ICH’s Management Committee (MC) in June 2018, shortly after becoming a Regulatory Member in November 2017. This enables HSA to take on a more active role in the development of ICH guidelines and to vote on all matters raised at the ICH meetings.

ICH Guidelines for Consultation

A portal is available on HSA’s website to provide latest updates on the proposed guidelines and FAQs which are open for consultation by ICH. We would like to encourage stakeholders to provide feedback, as your comments are integral to the implementation of ICH guidelines in Singapore

Click here for more information

January 2018

PIC/S is a co-operative arrangement in the field of Good Manufacturing Practice (GMP) for medicinal products, which now comprises 52 Participating Authorities. HSA was the first Asian Regulatory Authority to be elected as the Chair of PIC/S from 2018 to 2019. HSA was also the first Asian Regulatory Authority to join PIC/S in 2000, followed by eight other Authorities from Asia. This reflects the growing contribution by Asian Regulatory Authorities to the harmonisation work of PIC/S.

Click here for more information

April 2019

As announced in July 2018, HSA is revising the regulatory fees for health products. The fee increase averaging 3% will be implemented from 2 April 2019.