Asia-Pacific Roundup: TGA seeks feedback on drug shortages

RoundupsRoundups | 30 March 2021 |  By 

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on proposals to empower the agency to reduce the risk of medicine shortages and mitigate the impact when they do occur.
Information about shortages has improved since January 2019, when it became mandatory for sponsors to inform TGA of supply disruptions for reportable medicines, but ongoing problems with the availability of some products have spurred calls for further changes.
TGA set out several suggestions for how to better manage supply in a consultation document issued 29 March. The proposals include the prioritization of the evaluation and registration process for “certain important generic prescription medicines.” The agency also wants feedback on ways to encourage the registration of more generic versions of medicines known to be affected by shortages. By increasing the number of manufacturers providing products in areas prone to supply disruption, TGA could help to mitigate the impact of shortages of any one product.
The agency also proposes to support a more reliable supply of overseas-registered medicines as substitutes “when the Australian medicine is in longstanding or repeated shortage.” TGA now may approve the import of medicines not on the Australian Register of Therapeutic Goods in response to a shortage. However, the process provides time-limited clearances to import drugs on a case-by-case basis. When faced with a longstanding or repeated shortage, TGA may benefit from new powers.
TGA is accepting feedback until 17 May.
TGA Notice

PMDA releases real-world data guidelines to encourage use in regulatory filings

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has released two guidelines to drive greater use of real-world data (RWD) in regulatory submissions. The guidelines address the use of registry data in regulatory filings and points to consider about data reliability.
The agency has some experience of using RWD to evaluate the risks and benefits of medicines, according to PMDA chief executive Fujiwara Yasuhiro. For example, in 2013 PMDA approved tacrolimus for use in interstitial pneumonia associated with polymyositis after reviewing RWD. PMDA now wants to move beyond its current case-by-case approach to RWD. 
“By understanding the characteristics, advantages and limitations of RWD, we will plan to bolster RWD utilization in every stage of the medical product life cycle from the preapproval development to the post-marketing phase, towards enhancement for early patient access,” Yasuhiro said.
One guideline discusses the patient population, endpoints, statistical analysis methodology and other factors developers need to take into account when planning to use registry data in regulatory submissions. The other describes the points developers need to consider to ensure the reliability of RWD. Specifically, the guideline addresses quality assurance of data collection, the storage of records and other topics including ethics and privacy. Yasuhiro said English-language versions of the texts will “be available shortly.”
PMDA Statement

TGA defers switch to new serialization standard based on industry feedback

TGA has given the medicines industry more time to comply with the TGO 106 standard for serialization and data matrix codes. It now will take effect on 1 January 2023.
Through TGO 106, TGA is seeking to align its approach to serialization and data matrix codes with the global standards to provide consistency for manufacturers that serve multiple markets and ensure interoperability. TGO 106 does not mandate the use of serialization and data matrix codes but does set out requirements for companies that choose to use the technologies.
After reviewing 43 responses to a consultation held last year, TGA has delayed the commencement of the standard until 2023 “to allow sufficient time for medicine manufacturers and sponsors already serialising medicines or using data matrix codes to comply” with the new requirements.
The consultation also led TGA to allow sponsors “to use data matrix codes to identify medicines without a serial number where serialization is not required.” The change means a medicine that is not serialized will not need to include additional elements in the data matrix. TGA said the revised approach will help to maintain the “benefits for scanning in health care settings where appropriate technology exists” and support the gradual implementation of data matrix codes.
Other revisions include the restructuring of the standard to clarify the requirements for medicines that are serialized and those that are not serialized but “have a data matrix code that contains a GS1 Global Trade Item Number.” TGA has also sought to clarify the requirements for the primary pack.
TGA Notice, Consultation Feedback

New Zealand finalizes new warnings on paracetamol, delays implementation

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has finalized warnings on non-prescription products containing paracetamol. Medsafe changed its original proposals and delayed the implementation date after receiving pushback from some groups.
Officials proposed changing the warnings after a case of acute liver failure in a young girl. In a bid to prevent further adverse events, Medsafe proposed creating different warnings for liquid products, modified-release medicines and all other dosage forms. Respondents supported the creation of new conditions for different dosage forms but criticized other proposals.
The proposed paracetamol dosing table was a source of contention. Medsafe has acted on some of the criticisms, for example by including two dose volume rounding options. The implementation date for the changes to liquid dose forms is now 1 April 2023, six months after the original target and the deadline for the other types of paracetamol products.
Medsafe delayed the liquid dose implementation date after receiving feedback from organizations including Consumer Healthcare Products Australia, which argued the proposed 18-month transition “may not be adequate” given the extent of the required changes.
“Multiple steps are needed before new labelling can be implemented, including preparing label copy, internal company approvals and sign off, submission and approval by Medsafe, production planning and production, which may pose additional challenges given the lower New Zealand only volumes,” the industry organization wrote.
Medsafe Notice

Philippine FDA sets minimum performance requirements for COVID-19 tests

The Philippine Food and Drug Administration (FDA) has established minimum performance standards for different types of COVID-19 test. The standards are based on work by FDA and the World Health Organization (WHO).
FDA has set different requirements for PCR tests, antibody kits and antigen tests. The requirements for PCR and antibody tests are based on the work of Philippine agencies to determine acceptable performance. For PCR, FDA is requiring sensitivity of 95% and specificity of 99%. FDA is using WHO’s 80% sensitivity and 97% specificity benchmarks for antigen tests.
The Philippine regulatory agency said a “product profile indicating the specificity and sensitivity of the COVID-19 test kit shall be an additional requirement prior to the issuance” of clearance to sell a product under emergency COVID-19 measures. Clearances last six months. Companies with products already on the market will need to meet the new standards to retain their authorizations.
FDA Notice


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