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This application is a service of the Singapore Government.

Health Sciences Authority

Target Processing Timelines (CPM)

Target processing timelines – i.e. from the date of acceptance for evaluation to regulatory decision, excluding stop-clock are as follows. 审评时限(即从接受审评至评审结果确定所需要的时间),排除申请在申请方的时间,如下

The timelines stated (in working days) are subject to change. 所列的审评时限(工作日)可能会有变动

Type 类型   

No. of working days 工作日

New application 新申请  60
Amendment 变更申请 60

The Listing Process for New Applications 新申请的审评过程

Processing of new applications occurs in a 3 stage process: 新申请的审评分为三个阶段:

Step 1 Verification – A CPM listing application is submitted to HSA and the Verification Officer (VO) screens the application form and attachments for completeness and basic irregularities.  If irregularities are found, the VO would raise Input Requests to query the applicant for clarification.  If the application is found to be generally complete at this initial stage, the VO would submit it for evaluation.

第一阶段 (核实) : 当中成药产品申请提交至卫生科学局后,核实人员将审核申请表及附属文件的完整性以及准确性。如果发现有误,核实人员将会发出要求申请者更正的要求。如果经核实人员初步审核,此申请符合要求,即送交审评。

Step 2 Evaluation – The Evaluation Officer (EO) reviews the technical aspects of the application, including test reports, substantiation of label claims and manufacturing process. Input Requests may also be raised by the EO, until the final recommendation for approval or rejection of the application is made.

第二阶段 (审评) : 审评员将从技术角度对申请进行全面审评,包括核实检验报告的内容、标签上的宣称及生产工艺等。申请被推荐批准或拒绝前,审评员可能也会发出要求更正及提交更多信息的要求。

Step 3 Regulatory Decision – The Approving Officer (AO) assesses the recommendation by the EO against the information submitted in the application and formally issues the approval/rejection notification to applicants.  The AO could also requests for further clarification by sending the application back to the EO, who would then raise an Input Request to the applicant accordingly.  When the applicant resubmits the application, the process from Steps 2 to 3 is repeated, until the AO issues the final regulatory outcome.

第三阶段 (管理决定) : 批准人员评估审评员的建议及产品的相关信息后,将发出正式批准或拒绝通知书给申请者。批准人员也可能将申请退回给审评员以澄清申请的相关问题,审评员随即会发出相应的要求给申请者。当申请者回复申请后,将重复审评的第二及第三阶段,直到批准人员做出最终决定。

The Listing Process for Amendments 变更申请的审评过程

Processing of amendment applications occurs in a 3 stage process: 变更申请的审评分为三个阶段:

Step 1 Verification – A CPM amendment application is submitted to HSA and the Verification Officer (VO) screens the application form and supporting documents pertaining to the amendments indicated by the applicant. If irregularities are found, the VO would raise Input Requests to query the applicant for clarification.  If the amendment application is found to be generally complete at this initial stage, the VO would submit it for evaluation.

第一阶段 (核实) : 当中成药产品变更申请提交至卫生科学局后,核实人员将审核申请表及由申请者提交的用于修改的附属文件。如果发现有误,核实人员将会发出要求申请者更正的要求。如果经核实人员初步审核,此更正申请符合要求,即送交审评。

Step 2 Evaluation – The Evaluation Officer evaluates the technical and administrative aspects of the amendment application, and raises Input Requests where necessary, before recommending the amendment for approval or rejection.

第二阶段 (审评) : 审评员将从技术及管理角度对更正申请进行全面审评,此更正申请被推荐批准或拒绝前,审评员可能也会发出要求更正及提交更多信息的要求。

Step 3 Regulatory Decision – The Approving Officer (AO) assesses the recommendation by the EO against the information submitted in the application and formally issues the approval/rejection notification to applicants.  The AO could also requests for further clarification by sending the application back to the EO, who would then raise an Input Request to the applicant accordingly.  When the applicant resubmits the application, the process from Step 3 to 4 is repeated, until the AO issues the final regulatory outcome.

第三阶段 (管理决定) : 批准人员评估审评员的建议及产品的相关信息后,将发出正式批准或拒绝通知书给申请者。批准人员也可能将申请退回给审评员以澄清申请的相关问题,审评员随即会发出相应的要求给申请者。当申请者回复申请后,将重复审评的第三及条四阶段,直到批准人员做出最终决定。

HSA shall endeavour to meet the target processing timelines for all submitted applications.  Applicants should ensure that the applications and replies to Input Requests are complete before submission, to prevent unnecessary delays to the processing due to incomplete information and untimely responses.

卫生科学局将尽可能在审评时限内对所有的申请进行审评。申请者在呈交申请及回复询问前,应确保其信息的完整性及准确性,以避免不必要的耽搁。