Web1. Class 2 Cell, Tissue or Gene Therapy Products are required to be registered with the Health Sciences Authority before they can be supplied in Singapore. All applicants must … WebProduct Regulation. Medical devices; Therapeutic products; Health supplements; Traditions medicines; Chinese proprietary drug; Cosmetic products; Tobacco regulation; CTGTP; Additional Regulations. Clinical trials Controlled drugs and psychotropic substance; Poisons; Homoeopathic medicines ; Medicated olive also balms; Newest antiseptics
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Web29 jan. 2024 · Since CTGTPs cannot be terminally sterilized, they must be aseptically processed as stipulated under national and international CTGTP guidelines, including … Web1 apr. 2024 · All clinical trials of medicinal products must receive a Clinical Trial Certificate (CTC) from the HSA and an ethics approval from the relevant Institutional Review Board … rob brown real estate
Singapore: Public consultation on Proposed Regulations of ... - …
Web20 nov. 2024 · The HSA has noted that the CTGTP regulations are reportedly intended to facilitate patient access to therapies that meet appropriate safety, efficacy and quality … WebCASSS WebHSA CTGTP Home Cell, tissue and gene therapy products Check requirements now Regulatory overview Class 1 CTGTP notification Register a Class 2 CTGTP Variation applications Dealer's notice Dealer's licensing and certification Report adverse events … Overview of dealer's licences Understand the licensing requirements before you … 60 working days for Class 2 CTGTP trials. 5 working days. All clinical trials must be … Conducted as a result of requests, complaints or reports to us on suspected … Prepare the supporting document(s) and submit via CD/DVD or email to … Regulatory overview Understand the regulatory framework of clinical trials … Supporting innovation and timely access . As part of our aim to facilitate the … Registration overview Understand the cell, tissue or gene therapy product … Responsible Person . A "Responsible Person" (RP) needs to be named in the … rob brown realtor vernon bc