2024 Singapore Drug Registration Update

Singapore is an important drug market in Asia. Not because of the market size which is rather small, but because it is the second best overall healthcare market in Asia, after Japan. Getting drug approval and being successful in the Singapore market often leads to success in other Asian markets – especially in ASEAN.

The Health Science Authority (HSA) is in charge of registering drugs in Singapore. Applicants need to submit either a full, abridged, or verification evaluation dossier to the HSA. Over the last year or so, the HSA has outlined new drug registration requirements that have gone into effect or will do so soon.

First, in the fourth quarter of this year, Singapore plans to implement eCTD drug submissions. The use of eCTD submissions will be phased in over time and utilize ICH eCTD version 3.2.2. Singapore will publish more information on eCTD requirements over the next few months. The goal is to streamline the registration process using appropriate software.

Second, starting in October, drug companies submitting applications in Singapore need to include drug GMP compliance evidence. Three things can be evidence of GMP compliance in Singapore including a GMP inspection report, GMP certificate, or a letter from the PIC/S body. Drug applicants that do not have one of the three GMP documents outlined above will be rejected starting in the Fall.

Third, for a drug to be registered in Singapore, the applicant needs to determine if a patent declaration must be made. The HSA feels that this regulation is too old and unclear. Thus, going forward, only drug companies making an API, formulation of a drug, or companies that use the API for diagnostic and therapeutic purposes need to declare their patent. Singapore hopes this regulatory change will expedite future drug registrations and is asking industry for its feedback on this issue now.

Finally, Singapore plans to upgrade its API regulations. A new regulation is being planned called the Health Products Act. Under this act, API importers and wholesalers will now be further regulated via on-site inspections and also need to meet with Singapore’s Good Distribution Practices, GMP regulations, or PIC/S GMP regulations. The goal is to improve the API business in Singapore and bring their standards more closely aligned with international API standards.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

Source used in the article: https://www.bakermckenzie.com/-/media/files/insight/publications/2020/01/healthcare-reads-singapore/bmwl–therapeutic-products.pdf?la=en#:~:text=Under%20the%20HPA%2C%20all%20therapeutic,out%20such%20activities%20in%20Singapore.