Regulatory Focus™ > News Articles > 2022 > 2 > Asia-Pacific Roundup: New Zealand seeks feedback on harm warning on opioid labels

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Posted 22 February 2022 | By Nick Paul Taylor 

Asia-Pacific Roundup: New Zealand seeks feedback on harm warning on opioid labels

3007 The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is seeking feedback on its plans to add a warning about risks of overdose and dependence to the labels of opioid medicines.
 
New Zealand already requires an addiction warning on codeine-containing medicines. Now, the Medicines Adverse Reactions Committee is recommending  a similar warning and advisory statement for all opioid medicines. The committee noted that warnings included in the Label Statements Database (LSD) are lost when drugs are repackaged into dispensing packs, but still concluded the warnings have value.
 
Medsafe now is seeking feedback on three warnings it is considering for opioid labels. The warnings are: [this medicine] is an addictive substance; use of this medicine has the risks of overdose and dependence; or contains opioid.
 
The selected warning could apply to all opioids, extending the labeling requirement to cover molecules including fentanyl, methadone, morphine and oxycodone. The plan is to apply the warning to “all classifications, including prescription, and all uses” and give companies 12 months from when the LSD is updated to comply with the requirement.
 
Medsafe wants feedback on whether the package labeling for opioids should include a warning and advisory statement relating to the harm of abuse, misuse and dependence. If respondents agree that a warning is needed, Medsafe wants to know which of its three proposals they prefer, or if they have their own suggestions, and whether they agree with applying the requirement to “all classifications, including prescription, and all uses.” Medsafe is also seeking feedback on the planned 12-month transition period.
 
The consultation, which closes on 4 April, began one day after Medsafe posted an update on its review of the risks and benefits of dihydrocodeine. After holding a consultation in August, Medsafe presented a risk-benefit review of the opioid at the December meeting of the Medicines Adverse Reactions Committee. The committee agreed there is insufficient evidence to recommend revoking consent of the approved medicines but called for New Zealand to align with Australian warning statements for modified-release opioid products.
 
Medsafe Consultation, More
 
TGA provisionally approves Spikevax for children 6 years and up
 
Moderna has received provisional approval for Spikevax, it’s COVID-19 vaccine, for use in children aged six years and up in Australia. The Therapeutic Goods Administration (TGA) provisional approval follows the authorization of the vaccine for use in people aged 12 years and older in September.
 
 
The provisional approval follows a North American clinical trial that tested the vaccine in children aged six to 11 years. TGA said the immune response in that population was similar to that seen in older age groups.
 
The safety profile in children also was similar to that seen in adults, with short-term adverse events such as injection site pain, redness, swelling and fatigue among the most common side effects reported in the pediatric study.
 
As with other provisional approvals, TGA’s pediatric Spikevax decision is valid for two years and subject to certain conditions, including a requirement for Moderna to continue giving the agency long-term safety and efficacy data from ongoing clinical trials and postmarket assessments.
 
TGA granted provisional approval to Pfizer’s Comirnaty in a similar population – children aged five years and older – in late 2021.
 
TGA Notice
 
Japan’s PMDA updates breast implant safety info after new cancer cases
 
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared updated information on breast implant safety after professional bodies announced two new cases of a rare cancer linked to the devices.
 
In the past, PMDA has worked with regional officials to share information on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) prepared by professional bodies. Late last week, the agency again called for the commissioners of cities with health centers to help disseminate updated information about the risk of BIA-ALCL.
 
The update comes after reports of the third and fourth reported cases of the blood cancer in Japan. Both patients had received “an unapproved gel-filled breast implant,” according to PMDA.
 
PMDA wants to disseminate the update to reach people in Japan who have undergone, or are considering undergoing, breast reconstruction with a gel-filled breast implant. The materials encourage regular medical examination and self-examination to enable the detection of the disease.
 
PMDA Notice
 
Pakistan updates law to specify lot release certificates are a condition of vaccine sales
 
Manufacturers of human vaccines and certain other products now must provide  lot release certificates to sell their products in Pakistan.
 
Following the update, the Drug Regulatory Authority of Pakistan Act, 2012 now states: No human vaccines, blood products (plasma derivatives medicinal products) and anti-sera (antivenoms and anti-rabies) shall be sold and used until a “Lot Release Certificate” from the Federal Government Analyst of the National Control Laboratory for Biologicals, Islamabad has been obtained.
 
The previous version of the law said the certificates are needed for human biological drugs. The Drug Regulatory Authority of Pakistan (DRAP) revised the wording to specify the types of products that require the certificates, based on the recommendation of its Policy Board.
 
DRAP Notice
 
India’s NPPA cancels study of drug pricing policies
 
India’s National Pharmaceutical Pricing Authority (NPPA) has withdrawn its request for proposals for a study of global drug pricing policies because of “administrative exigencies.”
 
NPPA invited tenders for the study last month. At that time, NPPA planned to ask the winner of the tender to look at “operational implementation” of drug pricing policies in several countries and regions, including Brazil, China, the EU and the US. The goal was to understand global drug pricing methodologies and what India can learn from them.
 
However, NPPA, on the day it was due to stop accepting bids for the project, has canceled the request for proposal. NPPA attributed the cancellation to “administrative exigencies,” a word that means “an urgent need or demand.” The pricing authority asked bidders to collect the documents they submitted in person from its office.
 
NPPA Notice
 
Other news:
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published a guide to uploading bioequivalence study reports to its Quest 3+ online portal. The guide explains the requirements that uploaded documents must meet and sets out the materials NPRA will accept to support different elements of the submission process. The guide is the latest in a series of NPRA documents related to the Quest 3+ process for Section P9, which covers interchangeability and equivalence. NPRA Guide
 
DRAP has published draft guidelines on adverse event reporting by healthcare professionals. The draft is intended to increase the participation of healthcare professionals in reporting adverse events, for example by explaining what to report and when. DRAP published a similar document focused on adverse event reporting by patients and their relatives earlier this month. Draft Guidelines

 

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