Asia-Pacific Roundup: Singapore’s HSA gives industry a year to comply with new drug substance evidence requirements

Companies must be fully compliant with new requirements for evidence that chemical drug substances comply with good manufacturing practices (GMPs) from Singapore’s Health Sciences Authority (HSA) for by 1 October 2024.

After a consultation held in July and August showed “support for the initiative,” HSA has provided a detailed plan covering what companies need to do and by when. As well as providing a timeline for implementation, HSA has clarified the evidence that companies can submit to show compliance with GMPs.

The revised evidence requirements will apply prospectively to new or generic drug applications and minor variation applications for the addition of new drug substance. Companies can file one of three types of evidence to show GMP compliance when making those submissions. The evidence must cover the target drug substance:

A valid GMP certificate issued by any authority in the Pharmaceutical Inspection Co-operation Scheme (PIC/S);
A GMP inspection report and associated close-out letter are acceptable if a PIC/S authority does not issue GMP certificates; or
A manufacturing license and other evidence of GMP compliance from an accepted authority.

Officials have provided two additional options. Applicants can use a valid active pharmaceutical ingredient registration certificate listed on EUDRAGMP, or a valid Certificate of Suitability to the monographs of the European Pharmacopoeia issued by European Directorate for the Quality of Medicines and HealthCare. Again, the evidence must cover the drug substance of interest.

From 1 October 2024, HSA will reject applications that are submitted without the required evidence. During the transition period, HSA is “strongly” encouraging applicants to provide GMP compliance evidence if it is available to help “ensure a smooth transition when the requirement takes effect.”

The authority published an FAQ along with the detailed plan, clarifying that the GMP requirements do not apply retrospectively to products that are already registered, that intermediate manufacturers are outside of the scope of the rules and that companies can seek approval for a new drug before a GMP certificate is available.

HSA Notice, HSA FAQ

India launches pharma-medtech R&D policy, with a focus on how regulation facilitates innovation

The Indian government has launched the National Policy on Research and Development and Innovation in Pharma-MedTech Sector in India. Creating a regulatory environment that facilitates innovation and research in product development is a key part of the plan.

Details of the plan emerged in August when the Department of Pharmaceuticals outlined how changes to the regulatory framework could help address concerns about “the relatively low pace of development of biologics, biosimilars and other emerging products/trends” and improve the availability of “new age therapeutics” in India (RELATED: Asia-Pacific Roundup, Regulatory Focus, 22 August 2023).

Politicians launched the policy and discussed their objectives at an event last week. The goal is to turn the currently “cost-based” pharma and medtech sectors into “value-based and innovation-based” industries. Mansukh Mandaviya, minister of chemical and fertilizer, outlined how India wants to achieve self-reliance by strengthening its R&D infrastructure.

“We need to make policies, new products and new research according to the needs of our country and the world, in consultation with industries and academia. We should become so independent that we should not be dependent on anyone for our critical needs,” Mandaviya said in a statement.

The statement reaffirmed the focus on creating a “regulatory environment that facilitates innovation and research in product development, expanding the traditional regulatory objectives of safety and quality” but lacked additional details about the specific changes India will implement. The earlier statement outlined regulatory changes such as shorter review timelines that are intended to favor innovation.

Press Release

Pakistan posts alert as patients go blind after receiving repacked versions of Roche’s Avastin

The Drug Regulatory Authority of Pakistan (DRAP) has posted a recall alert after recipients of a repacked version of Roche’s Avastin (bevacizumab) went blind. DRAP outlined how actions unrelated to Roche affected the safety of the cancer drug and caused problems when it was used off-label to treat diabetic retinopathy.

Off-label use of Avastin in eye diseases is well established, with some healthcare systems using the drug rather than the more expensive anti-VEGF therapy Lucentis (ranibizumab). The dose is different for systemic use in the treatment of tumors than for intravitreal administration to treat eye conditions. The UK’s National Institute for Health Care and Excellent (NICE) said the suggested intravitreal dose is 1.25 mg monthly versus at least 5 mg per kilogram in cancer.

Adapting the Avastin dose for intravitreal use appears to have caused problems in Pakistan. The product is sold in 100 mg/4 ml and 400 mg/16 ml preparations in Pakistan for use in the treatment of colorectal and other metastatic carcinomas. DRAP outlined the impact of adapting the dose for off-label use.

“Since this drug was being dispensed/diluted/repacked in 1.25 mg/0.05 ml dose under unhygienic conditions and in an unapproved manner, therefore, its safety cannot be ascertained which may lead to damage and loss of vision in the patients,” DRAP wrote in its recall notice.

DRAP linked the products to “incidents of loss of vision in diabetic patients,” adding that the cases are tied to the “alteration/dispensing/dilution and sale of Avastin” and that the injections were administered “under unhygienic/non-sterile conditions illegally.”

Reuters provided additional information, explaining that 12 diabetic patients injected with the drug went blind. Authorities are questioning individuals believed to be involved in the distribution of the drug. Roche said it “strongly condemns this criminal act of counterfeiting” in a statement to Reuters.

DRAP Notice, Reuters

TGA seeks feedback on educating Australian healthcare about unique device identification

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on its draft plan for educating the healthcare system about unique device identification (UDI).

TGA was aiming to achieve voluntary compliance with UDI requirements by July but deferred the date because of a legislative hold-up. The regulator is yet to set new timeframes for voluntary or mandatory compliance but with UDI requirements planned in Australia and in place overseas, it expects healthcare providers to start seeing medical devices that carry the identifiers.

To prepare the sector, TGA is drafting a document intended to educate healthcare providers about the key concepts of UDI and highlight the importance of adopting the identifiers within their organizations. TGA released version 0.3 of the draft document for consultation last week.

The draft includes an overview of what UDIs are and how they will affect healthcare, as well as a closer look at the Australian system. TGA is accepting feedback on the draft until 31 October.

TGA Notice

Other news:

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has set a timeline for the reclassification of naproxen and liquid paracetamol to ensure a smooth transition to the new rules. Noting the need to give sponsors time “to make regulatory changes to affected products, and to enable manufacturing lead-in,” Medsafe set the implementation dates for both changes for 1 October 2024. Medsafe Notice, More

Asia-Pacific Roundup: Singapore’s HSA gives industry a year to comply with new drug substance evidence requirements

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