Asia-Pacific Roundup: TGA starts 5-year transition to new Australian medicine labeling standards
Australia’s Therapeutic Goods Administration (TGA) has adopted two new medicine labeling standards, starting a five-year countdown to mandatory compliance with the updated requirements.
The old standards, TGO 91 and TGO 92, were revoked automatically on 1 October. TGA used the sunsetting of the standards to update and improve Australia’s labeling requirements. The agency brought the new standards, TGO 115 and TGO 116, into effect when the old documents were sunsetted. However, TGA deferred enforcement to give sponsors time to interpret the requirements and update their labels.
For the next five years, manufacturers of prescription medicines can comply with either TGO 91 or TGO 115, and manufacturers of non-prescription medicines can comply with either TGO 92 or TGO 116. TGA set a 1 October 2031 deadline for full compliance with the new standards.
Sponsors can adopt certain provisions of TGO 115 and TGO 116 before transitioning to the full standards. The provisions, which are outlined in the new standards, are intended to provide additional flexibility during the transition period and reflect alternative labeling practices to those outlined in TGO 91 and TGO 92.
TGA plans to publish guidance “as soon as practicable” to support interpretation and implementation of the new standards. The agency will consider further updates to the guidance “over the coming months and throughout the transition, as required.” TGA intends to work with stakeholders over the first few months of the transition “to ensure there are no unintended drafting errors.”
TGO 115 and TGO 116 were informed by a consultation that TGA started late last year. The agency used the consultation to collect feedback on changes to the substances and warnings that must be declared on medicine labels, rule clarifications, consumer-focused changes to label information, and attempts to modernize the standards.
TGA also sought feedback on aligning the requirements with accepted labeling practices to reduce exemptions. Some drugs are exempt from specific TGO 91 and TGO 92 requirements. The new standards include alternative provisions intended to reduce the need for some “consents” for exemptions.
China’s NMPA and UK’s MHRA agree to ‘gradually enhance mutual trust’
Regulatory officials in China and the UK have agreed to “gradually enhance mutual trust by continuously deepening mutual understanding.”
China’s National Medical Products Administration (NMPA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) made the commitment in a letter of intent. The two sides signed the letter after a delegation led by NMPA Commissioner Huang Guo visited the UK.
Huang met with Anthony Harnden and Lawrence Tallon, the chair and chief executive, respectively, of MHRA. The leaders discussed medicine clinical trials and inspections, pharmacovigilance, and AI-enabled medical device regulation. Both sides agreed to cooperate to address challenges and help develop the pharmaceutical industry, leading to the letter of intent.
The NMPA delegation also met with representatives of the British life sciences industry. NMPA used the interactions to present China’s regulatory policy and collect industry opinions and suggestions about its rules.
Chinese officials traveled to the UK after meeting Tallon in Beijing. Regulatory leaders from Brazil and Indonesia attended the Beijing meeting, where the four parties agreed to deepen regulatory exchanges.
The meeting was part of a busy end to September for NMPA, which also met with a delegation from the Egyptian Drug Authority (EDA) in Beijing. EDA expressed hopes of strengthening cooperation in areas such as regulatory reliance and innovative drugs, NMPA said.
Press Release, EDA Notice, More
Philippine FDA posts draft guidance on on-site, remote, and hybrid inspections
The Philippine Food and Drug Administration (FDA) is seeking feedback on its proposed method for deciding whether to perform an on-site, remote, or hybrid inspection.
FDA set out its method in draft guidance that is open for comment until 27 October. Regulatory officials will consider “the intrinsic risk associated with the product, the manufacturing, distribution, and trade processes of the establishment, environmental factors, and resource availability,” to determine which “mode” of inspection is appropriate.
Inspectors will visit sites in person for all initial and major variation applications, as well as for renewal applications exempt from automatic processing. FDA also plans to perform on-site assessments “when there is a need to conduct verificatory inspection due to potential risks posed by health products to consumers.” On-site inspections will be mandatory in investigation or special assignments cases.
FDA is proposing to largely restrict remote inspections to assessments that would be hard or dangerous to perform in person. The agency will perform remote inspections when an area is hostile, for example because of an armed conflict. In certain circumstances, FDA may perform remote pre-licensing inspections of facilities in geographically isolated and disadvantaged areas.
The agency proposed different types of hybrid assessments. Inspectors may virtually verify documents or corrective actions after on-site assessments. In other cases, the virtual component of the inspection may happen before or during the on-site assessment.
Malaysia’s MDA makes changes to product classification application system
Malaysia’s Medical Device Authority (MDA) has updated its product classification application system (PCAS).
Companies use PCAS to apply for letters indicating whether MDA classifies their products as a medical device. MDA has enhanced the system “to improve the overall application experience, streamline the product classification submission and evaluation process, enhance service efficiency, and provide a clearer and more consistent process for applicants.”
The agency disclosed the changes alongside revisions to the application form and the implementation of a five-year validity period for newly issued product classification letters. MDA will automatically grant a three-year extension to letters that it issued previously with a two-year validity period.
Companies with product classification letters that have exceeded five years have one year to submit a renewal application. The renewal pathway applies when all information in the previously issued product classification letter remains unchanged. If information has changed, the company must file for a new letter. MDA will annul letters that are not renewed by the deadline.
The agency’s other key update establishes a 90-working-day deadline for responding to its requests for additional information. MDA will withdraw applications from companies that fail to respond to requests within 90 working days.
Singapore’s HSA revises guidance on PRISM submission after reviewing feedback
The Health Sciences Authority (HSA) has updated guidance on applying to register a therapeutic good in Singapore using the PRISM system. The changes took effect on 30 September.
PRISM supports a range of transactions between HSA and industry. HSA’s updated therapeutic good PRISM guidance defines “packaging configuration.” The newly defined term describes how a product is supplied, including its container closure system and the quantity of the medicine in the pack.
HSA explained how to determine if a product should be submitted as an individual registration or submitted as multiple packaging configurations under a single product registration.
“Each product registration application must correspond to one specific dosage form and strength. Where a therapeutic product is available in different dosage forms or strengths, separate applications must be submitted for each product,” the agency said.
HSA disclosed the changes alongside news that it is reviewing and updating the minor variation checklist. The agency plans to publish the checklist for consultation from mid-November to mid-December.
Other News:
TGA published a regulatory notice on listed medicines that contain whole live microorganisms as an active ingredient. TGA Notice
