Singapore’s Medical Device Regulations For medical device registrations, the Registrant is required to obtain a dealer’s license from the HSA, as only licensed medical device dealers are allowed to manufacture, import, or sell medical devices in Singapore. 9 Requirements for advertisement of unregistered therapeutic products 1 Citation and commencement Singapore Medical Device Regulatory Webcast.
Available product/disease specific guidelines should be followed when appropriate and relevant international guidelines should be referred to in the design of an appropriate clinical study programme for biosimilar products.The reference comparator product must be a Singapore Reference Biological Product (SRBP).
A final determination regarding the adequacy of the scientific justification and bridging data will be made during the evaluation of the application.The prices of therapeutic products (which include biological and biosimilar products) and medical devices are generally not regulated by the Singapore government. news and reports from all over the world. Health Products (Advertisement of Therapeutic Products) Regulations 2016 221) of Singapore (“Patents Act”).The biosimilar medicine is subject to the same regulatory framework as all other therapeutic products in Singapore, i.e. For more info AS PUBLISHED The administrative requirements are as per those required for an NDA via the abridged evaluation route. 12 Reference and trade advertisements
2 Definitions However, if the original biologics drug contains a new biological entity, an application under NDA-1 is required, while a biosimilar, which contains no new biological entity from its reference product, can apply as either NDA-2 or NDA-3.
structural and functional data) that compare all three products (the proposed biosimilar product, the SRBP and the RBP), and may also include clinical pharmacokinetics (“PK”) and/or pharmacodynamics (“PD”) bridging studies data for all three products. The four tiers of healthcare funding are direct subsidies from the government, Medisave, Medishield Life and Medifund.The government also administers a number of other subsidy schemes, such as the Community Health Assist Scheme, the Interim Disability Assistance Programme for the Elderly and the Medication Assistance Fund. Overseas manufacturers must comply with Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP standard and can submit a valid GMP certificate or other evidence of GMP compliance from a PIC/S member authority. The licence holder is also required to update HSA on the stability data of the batch of product selected each year to be part of the stability study program for the drug product.
They are not eligible for a generic drug application (GDA) for which only therapeutic products that contain one or more chemical entities and is essentially the same as a current registered product (Singapore Reference Product) in terms of its qualitative and quantitative composition of active ingredients.Yes, subject to requirements for patentability under the Patents Act (Cap. Acts All traders who are involved […]
The type of bridging data needed will typically include data from analytical studies (e.g.