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Singapore: HSA revises Guidance on Therapeutic Product Registration in Singapore

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In brief

The Therapeutic Products Branch and the Health Products Regulation Group of the Health Sciences Authority (HSA) recently revised its Guidance on Therapeutic Product Registration in Singapore (“TP Guidance“), which took effect on 29 April 2022. 

Key takeaways

  • The HSA releases guidance documents to help companies meet the regulatory requirements governing their therapeutic product dealings. Such documents are updated from time to time in order to improve regulatory efficiency and enhance clarity in the regulatory requirements and processes adopted by the HSA. 
  • The updated TP Guidance may therefore be viewed as a welcome change to prospective and current therapeutic product registrants. The revisions to the post-approval minor variations offer helpful additional guidance to assist registrants in streamlining their product lifecycle management efforts. Furthermore, amendments to Sections 14.3, 24.1 and Chapter E of the TP Guidance may enable prospective biological products and biosimilar registrants to enjoy cost and time savings in respect of their therapeutic product registration(s).    

Background

The Therapeutic Products Branch and the Health Products Regulation Group of the Health Sciences Authority (HSA) recently revised its Guidance on Therapeutic Product Registration (“TP Guidance“), which took effect on 29 April 2022. 

First, the HSA made four main revisions to the post-approval minor variations checklists (MIV-1 and MIV-2):

Nature of revisionIn greater detail
Recategorization of several chemical, manufacturing and controls variations from MIV-2 Notification to MIV-2 Do-And-TellDrug substance:Change in batch size of drug substance (DS) within 10‐fold of currently approved batch sizeTightening of DS specification limits or in-process tests of limits (IPC) of DSMinor change of test procedure of DSRevision of Certificate of Suitability (CEP) of DSSubmission of CEP for an approved DS manufacturerDrug product and excipients:Minor change in the manufacturing process for drug product (DP)Tightening of DP specification limits or IPC of DPMinor change of test procedure for excipientChange in source of empty hard capsule (non-animal derived material)Change of outer carton pack sizes of the DP
Releasing new checklists under MIV-2 Do-And-TellThe ‘Change of release shelf-life specification to comply with latest compendium’ checklist has been expanded into three separate checklists: Change of specification of DS to comply with latest compendiumChange of specification of DP to comply with latest compendiumChange of specification of excipient or DS starting material to comply with latest compendiumIntroduction of the ‘Change in the specification parameters and/or limits or test procedure of primary packaging material’ checklistIntroduction of the ‘Change in name and/or address of product registrant on product labelling’ checklist 
Releasing new checklists under MIV-1Introduction of the ‘Widening of specification limits of IPC or deletion of test parameters and limits of IPC of DP’ checklistIntroduction of the ‘Widening of specification limits and deletion of significant test parameter of excipients’ checklist
Other changesExpansion of scope of product labelling change under Do-And-TellInclusion of requirements for submission of electronic format of drug master file (DMF) prior to the submission of MIV-1 applications supported by DMFStreamlining of submission requirementsClarification of conditions and/or documentation requirements

Next, Sections 14.3 and 24.1 of the TP Guidance have been amended to extend the verification evaluation route to biological products and biosimilar products. This is intended to enable a greater leveraging of reference agencies’ assessments and minimize the duplication of effort. 

Finally, along with making minor and editorial amendments to several key appendices, the guidance initially set out in the now obsolete Appendix 15 has been consolidated under Chapter E of the updated TP Guidance to provide a centralized information source on the registration of biosimilar products.     

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Andy Leck is the head of the Intellectual Property and Technology (IPTech) Practice Group and a member of the Dispute Resolution Practice Group in Singapore. He is a core member of Baker McKenzie's regional IP practice and also leads the Myanmar IP Practice Group. Andy is recognised by reputable global industry and legal publications as a leader in his field. He was named on "The A-List: Singapore's Top 100 lawyers" by Asia Business Law Journal 2018. In addition, Chambers Asia Pacific notes that Andy is "a well-known IP practitioner who is highlighted for his record of handling major trade mark litigation, as well as commercial exploitation of IP rights in the media and technology sectors. He's been in the industry for a long time and has always been held in high regard. He is known to be very fair and is someone you would like to be in the trenches with you during negotiations." Furthermore, Asian Legal Business acknowledges Andy as a leading practitioner in his field and notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice.” Andy was appointed by the Intellectual Property Office of Singapore (IPOS) as an IP Adjudicator to hear disputes at IPOS for a two-year term from April 2021. He has been an appointed member of the Singapore Copyright Tribunal since May 2010 and a mediator with the WIPO Arbitration and Mediation Center. He is also appointed as a Notary Public & Commissioner for Oaths in Singapore. He previously served on the International Trademark Association’s Board of Directors and was a member of the executive committee.

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Ren Jun Lim is a principal with Baker McKenzie Wong & Leow. He represents local and international clients in both contentious and non-contentious intellectual property matters. He also advises on a full range of healthcare, as well as consumer goods-related legal and regulatory issues. Ren Jun co-leads Baker McKenzie Wong & Leow's Healthcare as well as Consumer Goods & Retail industry groups. He sits on the Law Society of Singapore IP Committee and on the Executive Committee of the Association of Information Security Professionals. He is also a member of the Vaccines Working Group, Singapore Association of Pharmaceutical Industries, a member of the International Trademark Association, as well as a member of the Regulatory Affairs Professionals Association. Ren Jun is ranked in the Silver tier for Individuals: Enforcement and Litigation and Individuals: Prosecution and Strategy, and a recommended lawyer for Individuals: Transactions by WTR 1000, 2020. He is also listed in Asia IP's Best 50 IP Expert, 2020, recognised as a Rising Star by Managing IP: IP Stars, 2019 and one of Singapore's 70 most influential lawyers aged 40 and under by Singapore Business Review, 2016. Ren Jun was acknowledged by WTR 1000 as a "trademark connoisseur who boasts supplementary knowledge of regulatory issues in the consumer products industry." He was also commended by clients for being "very responsive to enquiries and with a keen eye for detail, he is extremely hands-on. His meticulous and in-depth approach to strategising is key to the excellent outcomes we enjoy."

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