Asia-Pacific Roundup: Australia’s TGA seeks feedback on paper leaflets for injectable medicines

Australia’s Therapeutic Goods Administration (TGA) is running a consultation into the value of providing paper copies of product information (PI) documents in the packaging of injectable medicines.

PIs are summaries of the scientific information about the safe and effective use of prescription drugs that are prepared for HCPs. Typically running 10 to 35 pages, the documents cover the approved usage, dosage, and administrative instructions, contraindications, precautions, and adverse events information.

TGA decided to remove the PI from injectables administered by healthcare professionals in 2023. At that time, the agency continued to require companies to provide hard copies of the PI with injectables that are administered by patients and carers. Now, TGA is seeking input about whether the PI is valuable to patients and carers who administer injections.

The agency is asking patients and caregivers what medicine they inject and whether they find the hard copy of the PI useful. TGA wants to know when people read the PI and whether they read sections other than the instructions for injecting.

Other questions cover the impact of removing the PI. TGA is seeking feedback on whether people would be confident using other paper-based or electronic information about an injection if the PI was removed. Officials also want to know whether patients and carers are concerned that the PI may not contain the most up-to-date safety information and how much they value the environmental benefits of PI removal.

Another set of questions addresses the impact of PI provision on industry. TGA has asked if companies have any insights or data on the financial or environmental impact of the 2023 decision to remove the PI requirement for injectables given by healthcare professionals. The agency also wants to know whether companies see any downsides to removing the PI from consumer-administered injectables.

TGA is accepting feedback until 7 November. After reviewing the responses, officials will provide options for the Australian government to consider.

TGA Consultation

India’s CDSCO starts consultation into providing information to visually impaired people

The Central Drugs Standard Control Organization (CDSCO) is seeking feedback on providing information to blind or visually impaired people on drug product packaging.

Officials have received requests to look at the topic in light of the difficulties people face when trying to access information on medicine strips. CDSCO said blind and visually impaired people often rely on other people to learn the name and expiration date. The Drugs Consultative Committee looked at the topic in 2020, leading to the formation of a subcommittee to generate recommendations.

As a first step, the subcommittee recommended the voluntary implementation of additional labeling in Braille on drugs supplied in “mono carton pack size.” The subcommittee said manufacturers of products likely to be used by visually impaired people such as certain eye drops should pay particular attention to its advice. Products dispensed by healthcare professionals are exempt from the recommendation.

The subcommittee said Braille artwork should be validated by an agency such as the National Institute for the Empowerment of Persons with Intellectual Disabilities and be supported by text that complies with the European Commission’s guideline on the readability of drug labels. The subcommittee also said marketing authorization holders should make information available in Braille on request.

The main committee considered the recommendations in June and made further suggestions. Secondary packaging that contains 10 or more units of medicines may include Braille cards for giving to patients as needed, the committee said. The committee also suggested including a QR code that links to voice assistance.

CDSCO Consultation

TGA adopts ICH and EMA guidelines on clinical trials, devices, and pharmacovigilance

TGA has added documents from the European Medicines Agency (EMA) and International Council for Harmonisation (ICH) to the list of scientific guidelines that apply in Australia.

Australian officials adopt certain international scientific guidelines to provide advice to industry and help companies meet legislative requirements. The latest set of adopted guidelines features three texts, two from EMA and one from ICH.

The EMA guidelines cover the quality documentation for medicinal products when used with a medical device, as well as pharmacovigilance systems and their quality systems. EMA brought the medical device text into effect in 2022 to provide advice on what information to include in the quality part of a marketing authorization filing when seeking approval for a medicine that is used with a medical device.

The EMA pharmacovigilance guideline dates back to 2012. TGA said a section of the guideline on overall pharmacovigilance responsibilities within the EU regulatory network is not applicable in Australia. The agency asked industry to refer to local documents such as the Australian Privacy Principles when reading some other sections of the EMA guideline.

The ICH document is an addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials. ICH adopted the text in 2020 to inform the formulation of clinical trial objectives, design, conduct, analysis, and interpretation.

TGA Notice

Malaysia’s MDA updates guidance on medical device conformity assessment process

Malaysia’s Medical Device Authority (MDA) has updated two guidance documents about assessing the conformity of medical devices through the verification process.

Conformity assessments show medical devices are safe, perform as the manufacturer intends, and meet the essential principles. As MDA notes in the guidance documents, the process is “time consuming.” Because most medical devices have launched overseas before coming to Malaysia, MDA has identified a verification process as a way to shorten conformity assessments.

MDA published guidance on the verification process in March. Last week, the agency updated a guide for conformity assessment bodies and guidance on submitting a medical device for the verification process.

The agency removed “has been marketed for at least one year in the respective agencies’ jurisdictions” from the list of eligibility criteria for the verification process. MDA has also added health agencies in Singapore and Thailand to the list of recognized regulatory authorities and notified bodies.

Other changes include a reduction in the postmarket surveillance and vigilance reporting requirement. The original documents required companies to include a summary of reportable adverse events and field corrective actions, including recalls, for the past three to five years. MDA now only requires reports to go back three years.

MDA Guidance, More

Other News:

India’s CDSCO said it has no objection to the use of stickers to revise the maximum retail price in light of a recent reduction in the tax rate. Importers and manufacturers of class C and D medical devices can use stickers to provide the revised price for three months. The Drugs Controller General (India) told officials to expedite the clarification of the position on stickering. CDSCO Notice

Health leaders from China and Hong Kong met to discuss cooperation on drug regulation. Li Li, commissioner of China’s National Medical Products Administration (NMPA), outlined plans to provide talent and technical support for drug regulation in Hong Kong. Li also vowed to implement initiatives including the Cooperation Agreement on Pharmaceutical Regulation. NMPA Notice, More

The Philippine Food and Drug Administration (FDA) has extended the suspension of fees and charges by another 60 days. FDA originally suspended the fee revisions after a change of leadership at the agency. Officials extended the suspension to give FDA more time to finalize changes to its processes and ensure the full and effective implementation of the fees. FDA Notice

Asia-Pacific Roundup: Australia’s TGA seeks feedback on paper leaflets for injectable medicines

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