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- The Health Sciences Authority (HSA) provides guidance documents to help meet the regulatory requirements for dealing in therapeutic products1. All therapeutic products must be evaluated and approved by HSA before they can be sold in Singapore2. To supply a therapeutic product in Singapore, a company must make an application to HSA and submit scientific data to demonstrate that the product meets the required standards of quality, safety and efficacy2. The guidance documents cover product registration and post approval variation, dealer's licensing and certification, retail pharmacy licensing, safety monitoring and product recall1.Learn more:✕This summary was generated using AI based on multiple online sources. To view the original source information, use the "Learn more" links.Guidance documents for therapeutic products Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products. Product registration and post approval variation Dealer's licensing and certification Retail pharmacy licensing Safety monitoring and product recallwww.hsa.gov.sg/therapeutic-products/guidance-do…All therapeutic products must be evaluated and approved by HSA before they can be sold in Singapore. Any company that wishes to supply a therapeutic product in Singapore must make an application to HSA and submit scientific data to demonstrate that the product meets the required standards of quality, safety and efficacy.www.hsa.gov.sg/consumer-safety/articles/therapeu…
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HSA | Guidance documents for therapeutic products
WEBMay 15, 2024 · Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products. Product registration and post approval variation. Dealer's licensing and certification. Retail …
See results only from hsa.gov.sgGuidance documents for c…
Here is a list of regulatory guidances to help you understand the regulatory …
Register of Therapeutic Pro…
This search enables you to get a listing of all registered Therapeutic Products in …
Regulatory overview
We regulate therapeutic products in Singapore under the Health Products …
Therapeutic Products
You will need to register your therapeutic products and apply for a licence before …
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HSA | Therapeutic products
WEBYou will need to register your therapeutic products and apply for a licence before you import, manufacture or wholesale them in Singapore. Find out what are the requirements.
WEBINTRODUCTION. This guidance outlines the special access route under regulation 5(1)(b)(i) and 51 of the Health Products (Therapeutic Products) Regulations for the …
HSA | Guidance documents for clinical trials
WEBMar 28, 2024 · Here is a list of regulatory guidances to help you understand the regulatory requirements for conducting clinical trials. Conduct of clinical trials during COVID-19. …
Search by Product - Therapeutic Products - HSA
WEBOct 16, 2019 · This search enables you to get a listing of all registered Therapeutic Products in Singapore and their current approved Package Inserts. (PIs)/Patient …
Health Products (Therapeutic Products) Regulations 2016
WEB(CHAPTER 122D) Health Products (Therapeutic Products) Regulations 2016. In exercise of the powers conferred by sections 71 and 72 of the Health Products Act, the Health …
Singapore HSA Updates Guidance on Therapeutic Product …
WEBThe Health Sciences Authority (HSA) Singapore has published the updated guidance document on the regulatory processes and requirements for therapeutic product …
Singapore's HSA: Regulatory Updates for Therapeutic Product …
WEBJul 1, 2023 · On 30th June 2023, Singapore's Health Sciences Authority (HSA) released updated guidance on " Regulatory Updates for Therapeutic Product Registration" which …
Singapore: HSA revises Guidance on Therapeutic Product
WEBJun 5, 2022 · The Therapeutic Products Branch and the Health Products Regulation Group of the Health Sciences Authority (HSA) recently revised its Guidance on …
Singapore: Finalized guidance on e-labeling of …
WEBJun 7, 2021 · On 30 April 2021, the HSA Therapeutic Products Branch published its finalised guidance on the e-labelling of TPs in Singapore. The new guidance is effective from 30 April 2021. The documents, namely …
Singapore: HSA revises Guidance on Therapeutic Product …
WEBJun 5, 2022 · The Therapeutic Products Branch and the Health Products Regulation Group of the Health Sciences Authority (HSA) recently revised its Guidance on Therapeutic …
Singapore: Finalized guidance on e-labeling of therapeutic …
WEBJun 7, 2021 · On 30 April 2021, the HSA Therapeutic Products Branch published its finalised guidance on the e-labelling of TPs in Singapore. The new guidance is …
WEBunregistered therapeutic product to HSA. Any defects representing a serious threat to persons or public health must be reported to HSA within 48 hours of becoming aware of …
Guidance documents for Therapeutic Products - Regulatory Affairs
WEBJun 13, 2022 · This guidance document outlines the regulatory processes and requirements for Therapeutic Product registration. The Health Products Act (HPA) …
HSA | Regulatory overview of therapeutic products
WEBWe regulate therapeutic products in Singapore under the Health Products Act (HPA) and its regulations, including the Health Products (Therapeutic Products) Regulations 2016.
Singapore HSA Updates Unregistered Therapeutic Product …
WEBSingapore HSA Updates Guidance TPB-GN-004-005 regarding the Import and Supply of an Unregistered Therapeutic Product For Patients’ Use. In addition, the guidance also …
HSA releases New Initiatives for Registration of Therapeutic …
WEBSep 8, 2021 · the HSA has introduced an online self-guided tool for post-approval minor variations application and a DMF acknowledgment email and guidance on deficiency …
HSA | Guidance documents for CTGTP
WEBMay 7, 2024 · Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in cell, tissue and gene therapy …
HSA Therapeutic Product Defect Risk Classification Tool
WEBThe product defect risk classification tool is a query tool to help you identify the risk classification of a product defect. It is designed in accordance with the Guidance on the …
WEBHealth Product (Therapeutic Products) Regulations 2016. The Health Products Act (HPA) provides for the legislative basis for regulating the manufacture, import, supply, …
Singapore - HSA Makes Amendments To Guidance On …
WEBFeb 19, 2019 · The Health Sciences Authority ("HSA") has revised the Guidance on Therapeutic Product Registration in Singapore (the "Guidance"). The revised …
WEBJan 2, 2024 · Type of product: Licence information required to be entered in section 3: Registered Therapeutic Product 3.1 Therapeutic Products Importer’s Licence No. 3.4 …
Hsa - Guidance On Secondary Packaging of Therapeutic and
WEBThis document provides guidance for manufacturers conducting secondary packaging of therapeutic and medicinal products in Singapore. It outlines the regulatory …
Singapore: Finalized guidance on e-labelling of therapeutic …
WEBMay 5, 2021 · On 30 April 2021, the HSA Therapeutic Products Branch published its finalised guidance on the e-labelling of TPs in Singapore. The new guidance is …
OTP Interact Meeting for CBER-Regulated Products | FDA
WEBJun 12, 2024 · OTP Interact Meeting for CBER-Regulated Products. INTERACT or an IN itial T argeted E ngagement for R egulatory A dvice on C BER/CDER Produc T s is a …
E. coli advice issued amid rise in cases - GOV.UK
WEBJun 14, 2024 · Guidance and regulation. Detailed guidance, regulations and rules. Research and statistics. Reports, analysis and official statistics. Policy papers and …
FDA alerts drug manufacturers to the risk of benzene contamination
WEBDec 27, 2023 · The guidance notes that if benzene use is unavoidable to produce a drug product with a significant therapeutic advance, then its levels should be restricted to 2 …
Evaluating the Therapeutic Properties of Natural Products in ...
WEB2 days ago · The use of natural products as alternatives to traditional pharmacological treatments in orthodontics is gaining interest due to their anti-inflammatory, antibacterial, …
FDA Roundup: June 18, 2024 | FDA
WEB2 days ago · June 18, 2024. Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a …
Health Technology Assessment: two new guidance documents …
WEBJun 13, 2024 · In addition, an information document is made available online to clarify the scientific specifications of ‘new active substance’ and ‘therapeutic indication of …
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