In October 2024, the Health Sciences Authority (HSA) updated its Guidance on the Implementation of Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers (“Guidance”).
This is a timely amendment to the Guidance as the requirement for chemical DS manufacturers to provide evidence of GMP compliance became mandatory with effect from 1 October 2024, after a one-year grace period.

The Medical Devices Cluster of the Health Sciences Authority has released a draft guidance on the Change Management Program for Software as a Medical Device. Change Management Program is the new optional regulatory pathway that aims to streamline the SaMD regulatory framework and facilitate timely implementation of software changes for registered SaMDs in Singapore.

In brief
The regulations relating to patent linkage in the Health Products (Therapeutic Products) Regulations (“Regulations”) were recently amended through the Health Products (Therapeutic Products) (Amendment) Regulations 2024. The amendments came into force on 1 August 2024.

The changes aim to clarify for stakeholders which patents need to be considered when applying to register a therapeutic product and which patents fall under the patent declaration regulations. Additionally, they seek to reduce the potential for indiscriminate use of the patent declaration process.

Key takeaways
The amended patent declaration requirements aim to reduce potential patent disputes before the Health Sciences Authority (“HSA”) grants registration for therapeutic products. To achieve this, HSA will notify patent owners about the registration of products covered by a patent during its term without their consent or agreement. In particular, it is now clear that process patents do not fall within Regulation 23 of the Regulations.
Anyone who makes a false patent declaration when applying to register a therapeutic product, such as: (a) by making any statement or furnishing any document which the person knows or has reason to believe is false in a material particular; or (b) by intentionally suppressing any material fact, and furnishing information that is misleading, shall be guilty of an offense and liable on conviction to a fine of up to SGD 20,000 (approx. USD 15,500) and/or imprisonment for up to 12 months.
In more detail
Under Regulation 23 of the Regulations, the HSA is required to consider whether a patent is in force in respect of a therapeutic product that is sought to be registered. Therapeutic product applicants must, at the time of their application, furnish to HSA a patent declaration stating whether any patent is in force in respect of the relevant product and whether the applicant is the proprietor of the patent. Where the applicant is not the proprietor of the patent, the applicant must declare that:

the patentee has consented to or has acquiesced in the grant of the registration;
the patent is invalid; or
the patent will not be infringed by acts relating to the therapeutic product.
Following feedback received that the existing regulations lack clarity and create uncertainty as to the requirements for patent declarations, and following a public consultation held from 1 to 31 March 2024, HSA’s amendments to the Regulations specify that the following patent declarations must be furnished to HSA during registration of therapeutic products (see our previous client alert here):

A patent containing a claim for an active ingredient of that therapeutic product
A patent containing a claim for a formulation or composition of that therapeutic product
A patent containing a claim for the use of an active ingredient in the manufacture of that therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use
The amendments also clarified that the patent declaration requirement does not apply to the following patents:

A process patent, other than a process patent that contains a claim for the use of an active ingredient in the manufacture of a therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use
A patent that contains only claims relating to packaging
A patent that contains only claims relating to metabolites
A patent that contains only claims relating to intermediates
HSA further clarified that the types of patents that are subject to the requirements under Regulation 23 include the following:

A patent that contains a mixture of claims specified in Regulation 23(1)(a) and claims specified in Regulation 23(11), e.g., a patent containing claims for both an active ingredient of that therapeutic product and its metabolites
A patent containing a claim for the same polymorphic form of an active ingredient of that therapeutic product
Applicants must declare any subsisting restraining patent in relation to the therapeutic product for which registration is sought at the time of application and as required by HSA. HSA will then process registration applications based on the declared application category in the patent declaration form.

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On 31 July 2024, the Health Sciences Authority released updates to the registration of therapeutic products as part of its continued efforts to improve regulatory efficiency and enhance clarity in the regulatory requirements and processes.

In June 2024, the Health Sciences Authority (HSA) issued an alert to members of the public not to purchase or consume three products. The HSA’s analysis of these products revealed that they contained banned or potent ingredients.