Asia-Pacific Roundup: Australia to clear barriers to drug imports

Australia’s Therapeutic Goods Administration (TGA) is planning legal changes to support the importation of overseas substitutes for pharmaceutical products that are no longer on the local market. TGA set out the plan after receiving general support in a consultation last year.
 
The survey sought feedback on four potential ways to manage or mitigate drug shortages. One option would grant annual charge waivers to enable the import of overseas substitutes for discontinued medicines. Some respondents raised concerns the proposal would shift the waived annual charge onto other sponsors. Others were concerned that the proposal would create confusion because more discontinued products would be in the Australian Register of Therapeutic Goods (ARTG).
 
Medicines Australia was among the respondents to raise concerns about the subsidization of the waiver by other sponsors. The trade group saw “some value” in the proposal, noting that it “may enable the use of the s19A approach for products that have otherwise been removed from the ARTG due to the cost of ongoing fees.”
 
Based on the feedback, TGA plans to initiate amendments to the Therapeutic Goods Act 1989 to allow the importation of substitutes for discontinued or canceled medicines.
 
“Currently, the Australian medicine must be registered to allow the import of a substitute from overseas. This change would ensure continued supply of substitutes for discontinued medicines without the additional regulatory burden of requiring registration or an annual charge waiver for a medicine that has been discontinued,” TGA wrote.
 
The feedback on two proposals for incentivizing the registration of medicines with repeat or longstanding supply problems was mixed, with respondents questioning the approach’s effectiveness. TGA characterized the support for its other proposal as poor. The agency proposed prioritizing the registration of new generic medicines, but respondents cited concerns that the products may displace incumbents, thereby failing to make supply more robust.
 
TGA still plans to prioritize the evaluation of some applications. “We will prioritize the start of evaluation for registration applications that are identified to prevent or address a medicine shortage if it is in the interest of public health. Prioritization will occur following application lodgment on a case-by-case basis, within constraints of existing processes and resources,” TGA wrote. The agency also plans to create a web-based information hub to address barriers to registration.
 
The TGA initiatives will run alongside other strategies enacted since it ran the consultation in March 2021, including the Medicine Supply Guarantee, through which drugmakers have committed to holding at least four to six months of supply of some products. Australia also introduced Serious Scarcity Substitution Instruments to enable pharmacy-level substitution last year.
 
TGA Notice, Consultation Response
 
Malaysia posts pharmacovigilance inspection guidance to inform voluntary program
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published guidance on voluntary good pharmacovigilance practice (GVP) inspections ahead of the start of the new program in January 2023.
 
The goal of the new program is to help product registration holders to build and strengthen their pharmacovigilance systems and practices before the start of a full, mandatory GVP inspection program in the future.
 
The guidance explains that the program aims to identify compliance challenges and assess the feasibility of remote inspections, before providing information about what it will mean for affected companies in practice. NPRA will review the Pharmacovigilance System Summaries submitted by companies interested in participating and use a risk-based approach to select which to inspect.
 
Selected companies will undergo either a remote, hybrid or on-site inspection. NPRA will carry out remote assessments by reviewing documents and conducting a virtual inspection using streaming video and screen sharing technologies. Whatever the method, the process will entail the signing of a declaration by the company and the formation of an inspection plan.
 
NPRA will notify companies of its intent to inspect them 90 days in advance and send materials including the inspection plan 30 days before its assessment. The agency will request more information in advance ahead of remote inspections. After the inspection, NPRA will prepare a report that details its findings and share it with the company within 30 days. 
 
During the voluntary phase of the program, inspected companies will need to prepare corrective and preventive action (CAPA) reports within 30 days of receiving their reports but will not face regulatory action related to the findings. NPRA may request additional actions if the CAPA report fails to address the findings, with inspectors continuing to follow up until the plan is complete.
 
NPRA Notice, GVP Guidance
 
India proposes waiving BSE certificates if materials come from negligible risk countries
 
India has proposed changing its Medical Device Rules, 2017 to waive the need for companies to share certain transmissible disease certificates when sourcing animal products from negligible-risk countries.
 
Medical devices that use tissues or derivatives from animals that can carry transmissible spongiform encephalopathies (TSE) or bovine spongiform encephalopathy (BSE) pose a potential risk to humans. That risk has led regulators around the world to impose safeguards since the risk came to light. India is now proposing to selectively lift one of its safeguards.
 
The proposed addition to the rules states: “Provided that the requirement of TSEs or BSE Certificates shall not be necessary if the source is from animal species from a country of origin recognized as having negligible Bovine Spongiform Encephalopathy risk in accordance with the recommendations of the World Organisation for Animal Health.”
 
Most of Europe and countries including the US, Australia, Canada and New Zealand are on the list of countries with negligible risk. Exceptions include China, France and the UK.
 
Gazette Notification
 
TGA updates medicinal cannabis quality rules
 
TGA has updated its guidance on quality requirements for medicinal cannabis products to reflect recent revisions to the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017.
 
TGO 93 underwent changes last month to require imports of medicinal cannabis to meet good manufacturing practices, mandate child-resistant closures on high-risk goods and to clarify the requirements for microbiological testing. The update to the guidance, the first version of which dates back to 2017, brings the document in line with the latest iteration of TGO 93.
 
Some of the changes are subject to a transition period. The updated guidance clarifies that companies have until 1 July 2023 to comply with the sections on manufacturing quality, child-resistant packaging, labels, and microbiological attributes. All medicinal cannabis products released from that date need to comply with the requirements of TGO 93.
 
TGA Guidance
 
Other news:
 
TGA has published its performance report for the second half of 2021. The report shows median approval times for prescription medicine submissions remained well below the legislated timeframes, although there were steep rises in the time spent on minor variations. TGA Report