生物样本库

declaration on rejection, withdrawal, and deferral. Module 2 should contain a qual-ity overall summary, overview, and summaries of both the nonclinical and clinical documents. Module 3 should document the complete quality information of the product, while Module 4 captures all the nonclinical study data. The clinical studies provided in Module 5 should generally be conducted using the CTT product submit-ted in the application and in the appropriate patient population for the proposed indication(s) and/or dosing regimen(s). Risk management plans submitted to the EMA, risk evaluation and mitigation strategies submitted to the USFDA, and/or other relevant documents pertaining to such purposes should be included in Module 5. The need to implement a risk management plan in Singapore would be identifi ed on a case-by-case basis during the review process.

T he screening process will determine the completeness of the dossier for evalua-tion. The target processing timeline for screening is 25 working days before the fi rst communication, in the form of an input request or acceptance/non-acceptance notifi -cation. The target evaluation timeline is 270 working days from the date of acceptance of the dossier to issue a regulatory decision, excluding all stop-clocks. Upon product approval, the licence holder shall be responsible to maintain the product’s quality, effi cacy, and safety throughout the product life cycle. The authority must be notifi ed of any post-approval changes, which shall be subjected to regulatory approval [ 1].

M ore detailed information on product registration can be obtained from the guid-ance document, “Guidance on Medicinal Product Registration in Singapore” [ 1]. 3.2 C linical Trials

T he objectives of clinical trials regulation are:

• T o ensure the safety and quality of the investigational medicinal product admin-istered to clinical trial subjects.

• T o ensure that the scientifi c evidence is adequate to demonstrate product safety and effi cacy.

• T o ensure that the participants’ rights and interests are adequately protected and they are not exposed to undue risk, and that the safety and effi cacy data collected are credible.

I n Singapore, CTT and GT product clinical trials are approved as an individual clinical trial application. Besides ethics approval of clinical trials from the health-care institutional review board, the HSA issues regulatory approval in the form of a CTC. The CTC is issued in the name of principal investigator who is a locally reg-istered medical or dental practitioner. It is specifi c for each study protocol, and for each institution or site involved in the study. The guidelines on CTC application, submission process and documentary requirements are provided on the HSA web-site [ 9]. The target evaluation timeline is 60 working days from the date of a cceptance of a CTC application for evaluation to regulatory recommendation, excluding stop-clocks.