Asia-Pacific Roundup: TGA publishes guidance on advertising prescription medicines
The Therapeutic Goods Administration (TGA) has shared guidance on the restrictions imposed on people and companies advertising prescription medicines in Australia.
Australian law prohibits advertising prescription drugs to the public outside of limited circumstances. TGA has worked to clarify the rules and strengthen enforcement in recent years, naming unlawful ads as a priority, updating its guidance on testimonials, rewriting guidance on advertising medicinal cannabis, tightening oversight of the medical aesthetic sector, and revising its advice on social media.
The latest guidance lists the legislation that governs prescription drug ads, explains how companies can avoid unlawfully advertising medicines, describes the limited exceptions to the rules, and provides examples of noncompliant activities. TGA created the guidance by building on its existing resources, for example, by referencing an older document on determining if content is advertising in the section about avoiding unlawful ads.
Companies should remove all references to prescription medicines from their materials, TGA said. The agency clarified that the prohibition on references to prescription drugs goes beyond the use of trade names such as Botox and chemical names such as semaglutide.
Promotional materials that use abbreviations, indirect references, colloquial terms, and images may break the rules. The restrictions on direct and indirect references prohibit the use of terms such as CBD or weight-loss injections, as well as images to represent prescription medicines.
TGA’s examples of materials and activities likely to be considered advertising for prescription medicines include business names and logos that reference treatments, even if indirectly. A men’s health company logo featuring a stylized image of a blue pill may break the rules, TGA said. Pfizer’s Viagra (sildenafil) is provided as a blue pill.
Exceptions to the rules are limited. Australian law permits advertising directed to health professionals. Companies cannot benefit from the exemption by adding a disclaimer that consumers should speak to a healthcare professional about their treatment. Information healthcare professionals give patients is also exempt from the advertising ban, as are activities authorized or required by the government.
Philippine FDA seeks feedback on planned support for locally made drugs
The Philippine Food and Drug Administration (FDA) is conducting a consultation on plans to offer enhanced regulatory support and priority processing lanes for locally manufactured pharmaceutical products.
Philippine officials prioritized promoting self-sufficiency through local production in their medicine policy for 2022 to 2030. However, the FDA said it lacks “concrete regulatory tools” to support the goal, noting that its existing frameworks typically apply the same requirements to imported and locally made products. The frameworks fail to account for the structural disadvantages faced by domestic producers, FDA said.
FDA has identified a need for enhanced regulatory support. Priority processing lanes for establishment licensing and product registration of locally produced pharmaceutical products are among the agency’s ideas. The lanes will “ensure faster and more predictable turnaround times for licensing and registration applications through a dedicated pathway and assigned review unit,” FDA said.
To be eligible for the lanes, a product must have undergone at least one “substantive” pharmaceutical manufacturing operation in the Philippines. Formulation, processing, filling, and other critical production steps are examples of substantive operations. Secondary activities such as packing, repacking, altering, ornamenting, finishing, labeling, or quality control and release testing are insufficient for eligibility.
The agency plans to review initial license to operate applications and post-approval changes classified as major variations within 20 working days. FDA has allocated 10 working days for reviewing license renewal applications and minor variations.
Applicants who meet the eligibility criteria for the product registration fast track will receive decisions on initial, renewal, and post-approval change applications for prescription drugs within 90 working days. The agency has proposed a 65-day turnaround time for applications for other pharmaceutical products.
Other proposals include pre-registration meetings for novel pharmaceutical products. The meetings will allow local drugmakers to receive guidance, strengthening their competitiveness and encouraging entry into higher-value market segments, FDA said.
FDA is accepting feedback on the proposals until 17 July.
NMPA and Novo Nordisk leaders meet in China ahead of oral Wegovy filing
The deputy commissioner of China’s National Medical Products Administration (NMPA) has met with Novo Nordisk’s chair, Lars Rebien Sørensen, in Beijing.
Sørensen was joined by Denmark’s ambassador to China at the meeting with NMPA’s Yang Sheng. The two sides “exchanged views on deepening bilateral communication and collaboration, improving regulatory oversight and service delivery, and advancing the development of high-quality pharmaceutical products” in China and Denmark, NMPA said.
The meeting preceded Novo’s planned filing for NMPA approval of the oral formulation of its blockbuster obesity drug, Wegovy. While Novo beat Eli Lilly to the oral weight-loss market in the US, the Danish drugmaker looks set to trail its rival in China. Lilly filed for NMPA approval of orforglipron, the oral GLP-1 drug it markets in the US as Foundayo, late last year.
WHO posts alert after falsified copies of Novartis’ Jakavi found in Iran
The World Health Organization (WHO) has published an alert about falsified copies of Novartis’ cancer drug Jakavi that were found in countries including Iran.
Falsified versions of the JAK inhibitor were illicitly sold via online platforms and, in at least one instance, supplied to patients from a pharmacy. WHO has received reports of the falsified products in Iran, Russia, and Türkiye. Novartis confirmed that the batch numbers are not genuine and found that a product sold in Türkiye contained none of the active ingredient, ruxolitinib.
Visual discrepancies in the packaging, such as the lack of a batch number on blister strips, show that the products are falsified. WHO advises increased surveillance and monitoring of the supply chain, especially online platforms and other unregulated markets, in countries and regions likely to be affected by the falsified products.
People who receive falsified Jakavi, a drug used in patients who are particularly vulnerable to ineffective medicines, may deteriorate rapidly or have severe clinical outcomes, WHO said. The public health body is encouraging healthcare professionals to report any unusual adverse events.
Other news
India’s Central Drugs Standard Control Organisation (CDSCO) formed a committee to provide guidance on the disclosure of information. The panel will review CDSCO’s compliance with rules on proactive information sharing, identify records the agency should publish, and recommend ways to make the agency more transparent and its materials more accessible. CDSCO Notice
The Indian Pharmacopoeia Commission (IPC) participated in the 16th International Meeting of World Pharmacopoeias in Brazil. Discussions at the meeting reaffirmed that Indian standards are comparable with leading international pharmacopoeias, IPC said. IPC joined American, European, and Japanese authorities on the Pharmacopeial Discussion Group in 2023. Press Release
The Philippine FDA temporarily suspended its calibration services for radiotherapy dosimeters because of problems with its Cobalt-60 machine. FDA will accept requests for intercomparison output calibration of radiotherapy dosimeters with its available field dosimeters as alternative evidence of compliance. The temporary alternative will remain in effect until the end of 2027. FDA Notice
