Asia-Pacific Roundup: Medsafe considers potency information to corticosteroid labels

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is running a consultation on plans to add potency information to the labels of topical corticosteroids.

Topical corticosteroids treat inflammatory skin conditions such as eczema, dermatitis, and psoriasis. They occasionally cause serious side effects related to the amount, potency, and duration of use.

New Zealand’s Medicines Adverse Reactions Committee (MARC) reviewed the risk of topical steroid withdrawal reactions in March and found inappropriate overuse of the products. In the UK, officials have moved to mitigate the risks by adding potency information to the product labels. MARC said adopting a similar policy would be helpful for consumers in New Zealand.

Medsafe seeks feedback on plans to add the statement, “Contains [mildly potent, moderately potent, potent, very potent] corticosteroid” to product labels. The statement would apply to prescription and over-the-counter medicines. Plain corticosteroids and products that combine the steroids with other active ingredients, such as antifungals, antibiotics, antivirals, or calcipotriol, would be affected.

The agency considers hydrocortisone a mild corticosteroid. Clobetasone and triamcinolone are classified as moderate corticosteroids. Betamethasone valerate, betamethasone dipropionate, hydrocortisone butyrate, mometasone furoate, and methylprednisolone aceponate are considered potent corticosteroids. Clobetasol propionate and betamethasone dipropionate, in an optimized vehicle, are classified as very potent.

Hydrocortisone, clobetasone, and alclometasone must carry warning and advisory statements on their labels. However, none of the statements concern the potency of the corticosteroid. Companies would need to adopt the new statement within 18 months of the Label Statements Database being updated.

Medsafe said the proposed statement will help consumers recognize that the product is a topical corticosteroid, which the agency said is important when different skin products are prescribed.

The agency said labeling may prevent accidental use of more potent corticosteroids on more delicate areas of the body when consumers are prescribed multiple topical corticosteroids of different potencies. Medsafe sees the labeling requirement enhancing consumer knowledge and encouraging engagement in managing skin conditions.

Officials are conducting the consultation to determine whether the potency rule is supported and to gather views on the conditions that apply to the statement and its implementation date. Medsafe is also collecting feedback on the terms that should be used to describe the potency and the grouping of the different corticosteroids.

The consultation closes on 28 July.

Medsafe Consultation

DRAP finalizes guidance on Pakistan’s EUA framework

The Drug Regulatory Authority of Pakistan (DRAP) has finalized guidance on its framework for granting emergency use authorization (EUA) to medicinal products during public health emergencies.

DRAP sought feedback on a draft version of the guidance in May. The finalized guidance published last week is identical to the draft version. Finalizing the document gives Pakistan a framework for granting EUAs for the first time.

The guidance covers the authorization of medicinal products when there is “a heightened risk of attack on the general public’s life, health, safety, or a significant potential to affect national security.” Under such circumstances, “public health authorities may be willing to tolerate less certainty about the efficacy and safety of products,” DRAP said, because of the threat to health and lack of ways to mitigate the risks.

DRAP will require applicants to show that the known and potential benefits outweigh the known and potential risks, comply with good manufacturing practices, and agree to complete development. The remaining clinical trials and other testing needed to complete development and seek full approval must already be underway at the time of the EUA application.

The guidance lacks a targeted turnaround time for processing EUA applications. DRAP said the length of time required for action will vary, but it is likely that EUAs “will be acted upon with highest priority” if a public health emergency is active or imminent.

DRAP Guidance

NMPA shares next steps for China’s vaccine, pharmaceutical manufacturing QMSs

The National Medical Products Administration (NMPA) has provided an update on China’s vaccine regulation and pharmaceutical manufacturing inspection quality management system (QMSs).

NMPA established the systems to meet the assessment requirements of the World Health Organization’s national regulatory authority for vaccines and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Chinese regulator also sees the systems as an enhancement to its vaccine regulation and pharmaceutical manufacturing inspection capabilities.

Earlier this month, NMPA held its annual review of the systems. NMPA said the systems are appropriate, adequate, effective, and used in whole-lifecycle monitoring, evaluation, and inspection. The meeting also “highlighted identified problems and follow-up rectifications, and offered suggestions for system improvement,” NMPA said.

NMPA Commissioner Li Li, who chaired the meeting, identified a need for enhanced nationwide coordination and cooperation in establishing and operating QMS standards. Li called for promoting “robust drug regulatory capabilities based on sound QMS in line with international standards, so as to contribute to the high-quality development of China's pharmaceutical industry.”

NMPA Notice

Hong Kong prepares for 1-on-1 pre-NDA meetings to improve application quality

Hong Kong’s Department of Health is preparing to offer one-to-one meetings with applicants seeking approval under its “1+” mechanism.

The mechanism allows companies to use an approval from one reference drug regulatory authority to support requests for authorization in Hong Kong. Last week, the health department ran its first workshop to provide guidance and share good practices and real-life experiences on submitting applications under the mechanism. Officials used the event to provide an update on plans to offer one-to-one meetings.

“As the trade gains a better understanding of the application process through the briefing seminars and workshops, the pre-NDA meetings will greatly improve the quality of the application documents and hence the processing efficiency,” the Department of Health said.

Officials aim to start offering the meeting service in the fourth quarter. The health department plans to share more details of its initiative and the arrangements for the meeting closer to the scheme's launch.

Press Release

Other news

Researchers at the Pharmaceuticals and Medical Devices Agency (PMDA) have found that the publication of a bioequivalence guideline greatly influenced the methods used to study topical generic drugs in Japan. The researchers said Japan may consider a biowaiver approach based on Q1/Q2 and Q3 similarity and in vitro test equivalence, echoing US and European approaches. PMDA Paper

PMDA has discussed changes to the precautions for domperidone and Iodixanol. The update to the label for domperidone lifts contraindications to stop women from becoming anxious when they learn they are pregnant. The benefits may outweigh the risks in some women. PMDA said anxiety about the effects of the drug could cause women to choose to undergo an unnecessary elective abortion. PMDA Report

Malaysia’s Medical Device Authority (MDA) is running a customer satisfaction survey. MDA said it will use the survey responses to improve the quality of its services further in the future. The survey, which MDA said takes less than five minutes to complete, is open until 10 July. MDA Notice

Asia-Pacific Roundup: Medsafe considers potency information to corticosteroid labels

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