Asia-Pacific Roundup: TGA posts guidance on manufacturing, advertising compounded medicines
Australia’s Therapeutic Goods Administration (TGA) has released guidance on manufacturing, supplying, and advertising compounded medicines to support compliance with its regulatory requirements.
TGA encourages physicians to use medicines included in the Australian Register of Therapeutic Goods (ARTG). However, Australia’s legislative framework allows compounding in certain circumstances to meet an individual patient’s clinical needs. TGA explains those circumstances and the rules on compounding in the guidance.
Medicines are exempt from inclusion in the ARTG when “they are dispensed or extemporaneously compounded, for a particular person for therapeutic application to that person,” TGA said. The patient must request the medicine before the pharmacist or health practitioner compounds the medicine.
The exemption does not apply to medicines that are used for gene therapy, medicinal cannabis products, or medicines that contain GLP-1 receptor agonist analogs. TGA removed GLP-1 receptor agonists, a class of medicine that was widely compounded amid shortages of drugs such as Novo Nordisk’s Ozempic, from the list of products eligible for pharmacist extemporaneous compounding in 2024.
Medicines compounded in hospitals may also be exempt from inclusion in the ARTG. The exemption applies if the hospital’s drug and therapeutic committee considers compounding appropriate and the drug is prepared in anticipation of being used by the site’s patients. The exemption is intended to ensure the availability of a medicine when shortages or delays could pose a significant risk to health and safety.
Sites compounding medicines need a TGA manufacturing license authorizing the activity or must qualify for an exemption. Under certain circumstances, medical practitioners, dentists, and other healthcare workers, pharmacists, biomedical engineers, radiochemists, and pharmacists in public hospitals, and herbalists, nutritionists, and naturopaths may be exempt from the requirement to hold a license.
Regulatory requirements on the consistency of product quality apply to compounded drugs. Ingredients and finished products are subject to the relevant monographs of the British, European, and US pharmacopeias.
Advertising restrictions apply to compounded medicines. Ads directed exclusively at health professionals are permitted, but promoting compounded medicines to the public is banned unless authorized or required by the government. Companies can advertise compounding services. However, TGA is advising companies to avoid references to specific products to avoid breaking the rules on advertising medicines.
China and Singapore agree to strengthen convergence of health product regulations
The medicine regulatory agencies of China and Singapore have signed a memorandum of understanding (MoU) to expand the scope of their collaboration.
China’s National Medical Products Administration (NMPA) and Singapore's Health Sciences Authority (HSA) signed the MoU in Beijing last week. The agreement expands the scope of the agencies’ existing cooperative activities to accelerate access to health products in both countries.
NMPA and HSA signed their first MoU in 2003 and strengthened the alliance through subsequent agreements. The previous agreement, which NMPA and HSA signed in 2021, covered chemical drugs, active pharmaceutical ingredients, biological products, traditional Chinese medicines, medical devices, and cosmetics. The new MoU also includes cell, tissue, and gene therapy products.
HSA plans to explore facilitative regulatory pathways, pilot innovative schemes, capacity building, and staff exchanges with NMPA. The agencies see scope to strengthen regulatory convergence and enhance opportunities for industry engagement to enhance their capabilities and responsiveness.
Activities supported under the previous MOU will continue. HSA said the agencies will keep collaborating on “the exchange of regulations, information and best practices, and potential joint efforts to combat counterfeit, falsified, and substandard health products, including collaboration on inspections of manufacturing facilities and testing.”
While HSA named cell, tissue, and gene therapy products as the new additions to the agreement, NMPA said the agencies held in-depth talks on a wider range of topics, including artificial intelligence-based products.
Japan’s PMDA shares advice on running pivotal trials in small patient populations
The Pharmaceuticals and Medical Devices Agency (PMDA) has published points to consider for sponsors planning to run “small clinical trials” in Japan.
PMDA defines a small clinical trial as a study intended to provide the primary safety and efficacy data for a drug but that has a sample size too small to ensure adequate statistical power for hypothesis testing in the primary analysis. The trials are designed to support applications for marketing approval but lack the scale, and by extension the statistical power, typically associated with pivotal studies.
The new regulatory advice document outlines the considerations for planning small clinical trials and the explanations needed to justify the appropriateness of the designs in meetings with PMDA. Sponsors should select the trial design and statistical methods in light of information including the characteristics of the target disease and the clinical pharmacological background of the drug candidate, PMDA said.
Companies should consult with PMDA to inform the planning of a small clinical trial and the composition of the clinical data package to demonstrate evidence of efficacy and safety for marketing approval.
Malaysia’s NPRA publishes guideline on good laboratory practice compliance program
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published guidance on its good laboratory practice (GLP) compliance program.
NPRA created the guidance to outline its role in overseeing GLP compliance, describe the mechanism for recognizing test facilities, and define the procedures for inspecting test facilities. Other objectives include establishing the requirements for reporting the outcomes of inspections, facilitating the exchange of information with other agencies, and enhancing the quality of nonclinical studies.
The document is the first edition of the guidance, but it is built on earlier documents. NPRA published the first version of its GLP Compliance Programme Manual in 2009, setting out its role as the compliance monitoring authority for the Organisation for Economic Co-operation and Development’s GLP principles. The new document is a revised and rebranded version of the fifth edition of the compliance manual.
MDA creates guidance on change management for registered devices in Malaysia
Malaysia’s Medical Device Authority (MDA) has shared guidance on change management for registered medical devices.
The document outlines key considerations for manufacturers that change or modify registered medical devices, as well as for companies handling updates triggered by post-market issues and revisions to their documents in preparation for re-registration. MDA has provided a risk-based approach for categorizing and reporting changes, plus alternative pathways for managing revisions to registered devices.
MDA created the document to replace existing guidance on change notifications for registered medical devices. However, while MDA has finalized the text, the new guidance will only take effect after the official launch of MedCAST 3.0, Malaysia’s upgraded digital regulatory system. The change notification guidance will remain in effect until the launch. MDA wants the industry to prepare for the new rules.
Other News:
The Indian Pharmacopoeia Commission (IPC) has partnered with three state pharmacy councils to support the creation of monitoring centers for adverse drug reactions. The agreements are intended to reinforce medicine safety surveillance systems and encourage the active participation of pharmacists and healthcare professionals in pharmacovigilance activities. IPC Notice
NPRA updated its frequently asked questions about implementing e-labeling for medicines in Malaysia. The update reflects a 7 May meeting of the Drug Control Authority, where officials agreed to end the use of certain printed materials for products with e-labels. No requests for printed materials were submitted during the voluntary implementation period, which began in May 2023. NPRA Notice
