Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Proposes Fining Individuals $15,000 for Drug Shortage Reporting Failings
Australia’s Therapeutic Goods Administration (TGA) will hit individuals who fail to comply with its new drug shortage reporting rules with fines of up to AU$21,000 ($15,000). TGA may fine companies that breach the rules 10 times as much in a bid to ensure compliance with the requirements.
Previous efforts to curb the rising frequency and severity of drug shortages in Australia floundered due to the slow and incomplete reporting of supply disruptions by manufacturers. At the start of the year, Australia responded to the problem by introducing mandatory reporting requirements. The new requirements could ensure TGA, healthcare professionals and the public have up-to-date information on drug shortages, provided manufacturers comply with the rules.
To encourage and facilitate compliance, TGA has published details of the requirements, disclosed punishments for offenders and shared guidance on how to manage and communicate drug shortages and discontinuations.
The documents state TGA will impose civil penalties on manufacturers that fail to report shortages or discontinuations on time. The maximum punishment for individuals and businesses is 100 and 1,000 penalty points, respectively. One penalty point equals AU$210.
While that means individuals and companies can face significant financial punishments, TGA will only impose civil penalties against “extreme” offenders, such as groups that make a "conscious decision to be non-compliant" and thereby create public health concerns. Organizations deemed by TGA to pose a lower compliance risk will face less punitive responses, ranging from the provision of educational materials up to the issuance of formal warning letters.
TGA shared details of its responses to noncompliance alongside guidance intended to help people meet the requirements. The guidance sets out how companies should respond to shortages, from the timelines for sending initial notifications through to the ongoing coordination of the situation.
Medicines Australia Pushes Politicians to Harmonize Clinical Trials as Election Nears
Medicines Australia has called for politicians to prioritize the harmonization of clinical trials. Writing in the run up to the 2019 Australian federal election, the trade group argued the next government should formulate a complete proposal within 12 months of taking office.
In its election policy wishlist, the trade group states it “seeks commitment to take a complete proposal, supported by relevant stakeholders, for clinical trial harmonization to [the Council of Australian Governments (COAG)]” within the first year of the new government. COAG is an intergovernmental forum made of groups including the federal government and the governments of the six states and two mainland territories.
Currently, clinical research programs run in Australia must comply with national rules, such as TGA’s “Note for guidance on good clinical practice,” and certain state-level requirements. Harmonization of the requirements could make it easier for sponsors to set up and run compliant trials in Australia.
The call for harmonization was one of five requests Medicines Australia made in its policy document. Medicines Australia also wants the next government to review the National Medicines Policy and cut the time it takes for new drugs to reach patients in Australia.
China Reviews Supervision of Cell and Gene Therapies Through Regulatory Action Plan
China’s National Medical Products Administration (NMPA) has put oversight of cell and gene therapies at the center of its drug regulatory science action plan. NMPA has adopted the plan to foster development of new regulatory tools, systems and processes and drive scientific projects.
The first batch of action plan projects picked by NMPA include the aforementioned effort to improve the technical evaluation and supervision of cell and gene therapies, plus initiatives focused on the safety and quality of nano drugs and the clinical assessment of traditional Chinese medicines. NMPA will add more projects to the action plan in the future.
Universities and scientific research institutions will support the action plan by carrying out some of the assessments and helping to develop new tools, standards and methods. NMPA also hopes the initiative will promote the advancement of regulatory science and training of people in the field.
TGA Starts Analysis of Surface Topography of Breast Implants
TGA has begun laboratory assessments of the surface topography of breast implants to inform its response to cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Engineers and scientists will take more than 2,000 sets of measurements from around 150 sample devices.
Australian officials revealed they had requested samples from manufacturers last month following news that their peers in Canada and France had banned certain devices. An expert working group set up by TGA declined to follow the Canadian and French lead because of gaps in the data, leading to a request for additional information and the samples.
The analysis of the samples will advance in parallel to the review of the additional information shared by manufacturers. TGA hopes that analyzing when devices came to market and their sales figures will provide a more accurate picture of the risks associated with each type of implant.
TGA expects to complete the analysis and decide whether to take action against any of the devices in mid-June. The agency is talking to agencies in North America and Europe and sharing information with them to support global efforts to understand the link between implants and BIA-ALCL.
Philippines FDA Posts Alert About Sales of Unregistered Roche Medical Device
The Philippines Food and Drug Administration (FDA) has posted an alert about purchases and use of an unregistered Roche device, cobas PCR Swab.
FDA’s post-marketing surveillance activities have shown that the device, which is used to collect samples for analysis on Roche’s cobas machines, has not been through the registration process used to validate the quality and safety of products sold in the Philippines.
In response, FDA issued an alert advising the public not to buy the devices and telling “all concerned establishments and/or entities” not to distribute the products until they go through the regulatory clearance process. FDA will impose regulatory actions and sanctions against organizations that carry on distributing the devices.
To enforce the rule, FDA has asked local government units and law enforcement agencies to make sure that the devices are not sold in their jurisdictions.
The Chinese Center for Drug Evaluation
(CDE) has issued a notice about the submission of materials related to applications for approval of branded and generic medicines. CDE is giving companies affected by the request 10 days to send the requested information on CD-ROMs. The notice includes details about how companies should organize and label the CD-ROMs. CDE Notice
Authorities have arrested two Samsung Bioepis
employees for allegedly falsifying and destroying evidence. The employees, one of whom is an executive, are the first people to be arrested as part of an investigation into whether Samsung violated accounting rules to artificially inflate the value of its Bioepis unit. Investigators are trying to learn if the employees acted independently. Financial Times
’s Department of Pharmaceuticals
(DoP) has rejected Biocon
's review petitions against the ceiling prices set for Blistro Trio 1 and Blistro Trio 2, metformin-based diabetes drugs. Biocon argued the National Pharmaceutical Pricing Authority
did not follow the appropriate procedure. However, DoP found Biocon’s arguments were without merit, leading it to reject the petitions. Pharmabiz