Public Consultation on the Proposed Subsidiary Legislation for the Transfer of Controls of Pharmaceutical Products to Health Products Act
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. This will provide greater clarity to the stakeholders as they would 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.
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 device was the first category of health products regulated under the HPA, with phased implementation from 2007 to full implementation in 2012. Over the same period, cosmetic product controls under were also implemented in phases from 2008 to 2011.
3 Pharmaceutical products will be introduced as a new category of health products in the First Schedule of the HPA as “therapeutic products”. The proposed scope of “therapeutic products” is mapped against what is conventionally regarded as pharmaceuticals, i.e., chemical and biologic drugs. This will bring the existing legislative controls for pharmaceutical products, which currently spread out across the Medicines Act and Poisons Act, to the HPA and the existing laws will be dis-applied.
Proposed Key Legislative Changes
4 The fundamental controls for pharmaceutical products under the existing laws which remain sound and relevant will be retained and transferred to the HPA. In transferring the controls, four sets of subsidiary legislation are proposed to be promulgated simultaneously under the HPA to cover the key regulatory aspects for pharmaceutical products, including manufacture, product registration, import, supply, clinical trials, presentation, advertisement, adverse event reporting and enforcement.
5 The major changes introduced are to enable a more effective and flexible regulation which include:
- Streamlining the licensing regime and the modular controls by allowing combined licence applications for dealer’s licences. This approach will enable streamlining and titration of regulatory requirements, which will translate into saving of regulatory costs for the industry;
- Moving away from pre-approval system for advertisement controls to industry self-regulation. In this age of the Internet and social media, information is easily available to the public and it is therefore no longer effective to rely on a permit system to curtail information flow. In line with international best practices, the regulations moving forward will allow industry to self-regulate based on a set of rules and guiding principles. This will empower the industry to produce health product-related information that enables public to make informed choices, while preserving adequate regulatory oversight by HSA;
- Refining the clinical trials framework to allow for the implementation of a risk-based approach. This move aims to enhance system efficiency and thereby promotes research and innovation in the local biomedical scene.
Period of Consultation
6 A series of public consultation for the proposed subsidiary legislation will be carried out in stages from 27 October 2014, starting with advertisement controls and retail pharmacy licensing, followed by the proposed definition for “therapeutic product”, its licensing regime and clinical trials controls.
7 The first in a series of public consultations are the 2 sets of subsidiary legislation, which cover the controls on advertisements and retail pharmacies licensing of TP. The key proposed changes include:
- Removal of the existing permit system for advertisements of TP. Instead, advertisers will self-regulate based on broad principles and requirements prescribed in the Regulations while HSA will strengthen its post-market controls.
- All direct-to-consumers advertisements of Pharmacy Only Medicines will carry advisories/ warnings as required by HSA.
- Inclusion of provisions on telepharmacy by licensed retail pharmacies into the HPA for better clarity
8 The public consultation for the other 2 sets of subsidiary legislation on the licensing regime of therapeutic products and its dealers, as well as that of clinical trial controls, will be conducted in the month of November.
9 HSA welcomes your comments and feedback on the first 2 sets of subsidiary legislation on the controls on advertisements and retail pharmacies licensing of therapeutic products. This first series of consultation will be held from 27 October 2014 to 23 November 2014.
10 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.
11 Where possible, you should highlight the provisions in the proposed draft for which you are providing your comments on.
12 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.
13 Please use the prescribed feedback template provided below to submit your feedback to us.
14 The feedback template may be submitted via:
a. Email – firstname.lastname@example.org ; or
b. Fax – 6478 9076
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