Public Consultations
Public Consultation on the Proposed Subsidiary Legislation for the Transfer of Controls of Pharmaceutical Products to the Health Products Act (II)
Audiences
Consumer
Healthcare professional
Industry member
Product type
Medical devices
Therapeutic Products
15 December 2015
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Proposed Health Products (Amendments To The First Schedule) Order 2015
Proposed Health Products (Therapeutic Products) Regulations 2015
Proposed Health Products (Clinical Trials) Regulations 2015
Proposed Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2015
Proposed Health Products (Medical Devices) (Amendment) Regulations 2015
The consultation is now closed.
Introduction
The Health Sciences Authority (HSA), a statutory board of the Ministry of Health, plans to port over the existing regulatory controls of pharmaceutical products from the Medicines Act (Cap. 176) and Poisons Act (Cap. 234) to the Health Products Act (Cap. 122D). This is part of HSA’s ongoing initiative to update and streamline the existing regulatory controls for health products and bring them under a single legislation. It will strengthen the existing legislative framework, enhance regulatory efficiency and provide greater clarity, as stakeholders will only need to refer to a single legislation. This exercise also aims to ensure that the controls remain relevant and adequate to cater for different operational and business models while safeguarding consumer safety.
2 The Health Products Act (HPA) provides the legislative and licensing framework for different categories of health products, which span a wide range from low to high risk products. Medical devices were the first category of health products regulated under the HPA in 2007, followed by cosmetic products in 2008.
3 Pharmaceutical products, conventionally termed as chemical and biologic drugs, will be introduced as a new category of health products in the First Schedule of the HPA using the term “therapeutic products”. Thereafter, the existing controls for pharmaceutical products under the Medicines Act and Poisons Act will be dis-applied.
Proposed Key Legislative Changes
4 This is the second in a series of planned consultations. This consultation covers the proposed definition for “therapeutic product”, its licensing regime and clinical trials controls. The key proposed changes include:
Its proposed definition based on the purpose of the product and its active ingredient(s) to ensure clarity in its scope;
Transition to an activity-based and tiered licensing regime for the registration, manufacture, import and wholesale of therapeutic products in Singapore. To facilitate current business practices, some examples of these changes include the streamlining of licence application processes and the bundling of licence fees;
Form A Poisons Licence will no longer be required for the supply of therapeutic products containing scheduled poisons. However, the current requirement that a Form A Poisons Licence holder for a company dealing in pharmacy-only medicines and prescription-only medicines must be a registered pharmacist or such other persons as approved by HSA, will be transferred to the TP Regulations as a requirement to name a Responsible Person (RP) in the Importer’s Licence and Wholesaler’s Licence.
Enhancing the post-market surveillance of therapeutic products in Singapore, including the implementation of risk management plans and submission of benefit-risk evaluation reports; maintaining of records and reporting of product defects; and refining the reporting timelines for serious adverse reactions;
Introduce a risk-based approach to the regulation of clinical trials and refinements to existing legal provisions in accordance with internationally recognised principles of Good Clinical Practice (GCP), to enhance transparency and to support global clinical development; and
Introduce a regulatory notification system, in place of the existing import approval system, to facilitate access to clinical research materials for use in clinical research.
Feedback Sought
5 HSA welcomes your comments and feedback on the proposed definition for “therapeutic products”, and the five sets of subsidiary legislation which cover its licensing regime and clinical trial controls. This consultation will be held from 15 December 2015 to 15 January 2016.
6 Please provide your name, the organisation you represent, mailing address, contact number and email address to enable us to follow up with you to clarify any issues, if necessary.
7 Where possible, you should highlight the specific regulation in the proposed draft you are providing your comments on.
8 Please note that the contents of any written feedback submitted, and the identity of the source, may be disclosed at the conclusion of this consultation. You may request for the feedback provided to be treated with confidence on grounds that the information is proprietary, confidential or commercially-sensitive. Such requests will be taken into consideration.
9 Please email your feedback using the prescribed template below to hsa_feedback@hsa.gov.sg by 15 January 2016.
1. Proposed Health Products (Amendment of First Schedule) Order [PDF, 110 KB]
2. Proposed Health Products (Therapeutic Products) Regulations [PDF, 1259 KB]
3. Summary of Proposed Changes for 1st Schedule and TP Regs [PDF, 69 KB]
4. Proposed Health Products (Clinical Trials) Regulations [PDF, 346 KB]
5. Summary of Proposed Changes_Clinical Trial Regs [PDF, 66 KB]
6. Proposed Health Products (TPs as Clinical Research Materials) Regulations [PDF, 228 KB]
7. Proposed Health Products (Medical Devices) (Amendment) Regulations [PDF, 113 KB]
8 Summary of Proposed Changes_Clinical Research Materials Regs [PDF, 85 KB]