WebNov 23, 2014 · There was a suggestion for HSA to consider allowing registered pharmacists to be Principal Investigators in clinical trials involving solely Pharmacy-only medicines, as pharmacists are trained in the use of such medicines. 29. WebFor clinical trials submitted on the basis of the Regulation, the Implementing Regulation (EU) 2024/556 of 24 March 2024 on detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council will apply.
HSA Clinical trials
WebOverview. In accordance with the FDCAct, 21CFR50, and 21CFR312, the Food & Drug Administration (FDA) has authority over clinical investigations for drug and biological products regulated by the agency. 21CFR312 specifies that the scope of the FDA’s assessment for investigational new drug applications (INDs) includes all clinical trials … WebOct 14, 2024 · HSA, Singapore - Implemented; Date: 1 January 2008; Reference: Reference made to these guidelines can be found in the ASEAN ACTD Part IV: Clinical Document guideline, which is adopted and published on HSA, Singapore Health Canada, Canada - Implemented; Date: 1 June 1995; Reference: Catalogue No. H42-2/67-7-1995E microsoft outlook backup maken
CLINICAL TRIALS GUIDANCE - Health Sciences Authority
WebMay 18, 2011 · implement clinical studies – To ensure efficient review of subsequent NDA by: • Facilitating close consultation between sponsors and FDA prior to Phase 3 and helping design acceptable major trials to support marketing approval – To benefit the consumer by: • Enhancing earlier availability of safe and effective drugs post-NDA WebMar 24, 2024 · Clinical trials have different purposes. What that purpose is helps define the type of trial it is. Behavioral trials evaluate or compare ways to promote behavioral changes designed to improve health.; Diagnostic trials study or compare tests or procedures for diagnosing a particular disease or condition.; Prevention trials look for better ways to … Webauthorised by the Authority, or notified to the Authority and the notification accepted by the Authority, under regulation 8 or 9 of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016); or (b) issued with a certificate under regulation 8 of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016); how to create a record using lwc