Asia-Pacific Roundup: Singapore’s HSA seeks feedback on draft active pharmaceutical ingredient legislation

Singapore’s Health Sciences Authority (HSA) has released draft legislation on the regulation of active pharmaceutical ingredients (APIs) for consultation. The legislation is intended to create “a fit-for-purpose and risk-based licensing framework” that is aligned with international standards.

Currently, Singapore regulates APIs under the Poisons Act 1938 and Medicines Act 1975. The legislation requires licensing of importers and wholesalers under the Poisons Act and encourages manufacturers to apply for voluntary good manufacturing practice (GMP) certification under the Medicines Act. HSA said it has identified a need for a new approach.

“With the increasing complexity in the manufacturing and supply chain of active ingredients, streamlined and risk-based regulatory controls will ensure that active ingredients consistently meet the appropriate quality standards. To achieve this, HSA will be consolidating and enhancing the regulatory controls for active ingredients under one single Act – the Health Products Act (HPA),” the authority wrote.

HSA has three objectives for the HPA regulations: to safeguard public health by ensuring that APIs are consistently manufactured, stored and distributed; to provide a fit-for-purpose and risk-based licensing framework that aligns with international standards and enhances mutual confidence with its overseas counterparts; and to provide greater clarity on the legal requirements and regulatory controls.

The proposed law will apply to ingredients that are “usable as pharmacologically active constituents in the manufacture” of therapeutics, cell tissue or gene therapies “that are not a result of only minimal manipulation of cell or tissue” and medical devices.

HSA is proposing to apply risk-based controls to products that meet those criteria. The authority plans to apply Inspection and licensing controls to all manufacturers, importers and wholesalers of APIs “used in health products for local clinical use.” HSA will conduct inspections in line with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide or HSA good distribution practice standard.

The authority will apply “less stringent” requirements to importers and wholesalers that handle APIs that will be used in non-clinical activities such as studies in animals. HSA wants to reserve the right to inspect facilities that are subject to the less stringent requirements. The changes will free licensed importers and wholesalers of APIs from the need to hold a separate license under the Poisons Act.

HSA is seeking feedback on the proposals until 17 August. In parallel, the authority is seeking feedback on the lead times companies will need to prepare for full implementation of the submission requirement for evidence of GMP compliance for chemical drug substance (DS) manufacturers. The requirement will apply to new or generic drug applications and minor variation applications for new DS manufacturers.

A valid GMP certificate issued by any PIC/S authority is acceptable compliance evidence. Alternatively, HSA will accept a valid Certificate of Suitability to the monographs of the European Pharmacopoeia or an API registration certificate listed on EUDRAGMP. HSA is accepting feedback on the lead times for the transition until 14 August.

HSA Notice, More

Philippine FDA starts consultation on rules and regulations on registration applications

The Philippine Food and Drug Administration (FDA) is seeking feedback on the rules and regulations on registration applications for authorizations and certifications of drug products and drug substances.

An administrative order issued in 1989 currently provides guidelines on the registration of products with the FDA. Citing “the fast-changing technologies and regulatory landscape in pharmaceutical regulations,” the administration has identified a need “to develop responsive policy guidelines for the authorization of drugs by providing scientific evidence on the quality, safety, and efficacy of the products being applied.”

The draft guidelines are intended to address that need while also “institutionalizing regulatory reliance ... to avoid redundancy in regulation, particularly products that are already authorized in other countries that passed the stringent regulatory review process.”

Through the new administrative order, the FDA is providing updated guidelines for: the identification of registrable drug products and drug substances; types of registration applications for drug authorization; regulatory review implemented by the FDA on the applications and the applicable evaluation routes; and regulatory decisions on the applications.

The administrative order will apply to authorizations to market and export all drug products and drug substances for human use, as well as to clearances for foreign donations and DOH-use authorizations. To inform those activities, FDA has created a document that defines tens of terms and covers the general guidelines for drug registration, including the process for filing and post-registration applications.

FDA is accepting feedback until 31 July.

FDA Notice

TGA relaxes rules on mifepristone and misoprostol prescriptions, imposes new warning

Australia’s Therapeutic Goods Administration (TGA) has relaxed the restrictions on the prescription of mifepristone and misoprostol, a pair of drugs used for the medical termination of pregnancy.

Under the prior restrictions, doctors needed to be certified to prescribe the drug combination, which is sold in Australia as MS-2 Step, and only registered pharmacists could dispense the medicine. MS Health applied to change the restrictions on the use of MS-2 Step to terminate pregnancies up to 63 days of gestation.

TGA approved the application. The revised rules end the need for certification, meaning any healthcare practitioner with appropriate qualifications and training can prescribe the medicine. Similarly, TGA has lifted the restrictions on dispensing of the medicine.

In conjunction with the changes, TGA has added a warning to the product information. The warning describes the circumstances in which a patient should be referred to a medical practitioner. TGA sees the new rules “addressing important access issues for patients who require this medication.” Professor Danielle Mazza, Monash University General Practice Chair, shared an example of such an issue.

“Say you’re a community pharmacist in a rural town, and you’re the only pharmacy there, if that particular pharmacist was sick that day, or went on maternity leave, or was on holiday, that pharmacy wouldn’t be able to dispense the medication,” Mazza told newsGP. The new rules will prevent that problem from occurring.

TGA Notice, newsGP

Pakistan’s DRAP warns of ‘suspected increase’ in availability of falsified GLP-1 agonists

The Drug Regulatory Authority of Pakistan (DRAP) has warned of a “suspected increase” in the availability of falsified versions of glucagon-like peptide-1 (GLP-1) receptor agonists such as Novo Nordisk’s Ozempic.

DRAP reported “a surge of online information” promoting the use of the class of medicines for weight loss. Pakistan is yet to approve a GLP-1 drug for the treatment of overweight or obesity, unlike some other countries, and DRAP thinks the surge in online information is “encouraging risky procurement behaviors” by consumers.

“Numerous online sources offer GLP-1 RA products for sale without requiring a prescription. The quality and safety of these medical products manufactured and distributed in poorly controlled environments (such as the internet) cannot be assured,” DRAP wrote. “It is possible that several versions of falsified GLP-1 RA – regardless of the brand name – are in circulation and available online.”

DRAP’s warning follows other reports that producers of falsified medicines are seizing the opportunities that have been created as demand for GLP-1 receptor agonists has exceeded demand and constrained the supply of Novo’s Ozempic and its sister medication Wegovy. The Swiss regulator recently warned patients were hospitalized after taking falsified products and DRAP said the World Health Organization has received reports of increased availability of falsified GLP-1 drugs over the past six months.

DRAP Notice

Asia-Pacific Roundup: Singapore’s HSA seeks feedback on draft active pharmaceutical ingredient legislation

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