Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Australia and New Zealand Defer Decision on Potential Breast Implant Ban
Regulatory agencies in Australia and New Zealand have held off on deciding whether to ban certain breast implants over a link to a form of cancer. The agencies clarified their positions after their peers in Canada and France prohibited the sale of Allergan’s Biocell.
Authorities in Canada and France think the link between certain textured breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is strong and serious enough to justify stopping the sale of some devices. Other agencies have been more circumspect in their responses, opting to just continue monitoring the situation in the belief that the causal link between BIA-ALCL and the devices is currently too weak to justify a ban.
This week, Australia’s Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) joined the ranks of regulatory agencies that want to see more data before taking action.
TGA convened its breast implant expert working group after learning of the Canadian and French bans. The group “identified gaps in the data currently available to inform an assessment of the true rate of BIA-ALCL in Australia particularly with different grades of texture of the implants.” Coupled with a belief that textured implants have benefits, particularly for reconstructive surgery, the gaps in the data led the working group to defer a decision on whether to ban the devices.
The working group hopes manufacturers can fill in some of the evidence gaps. After meeting, the experts asked all Australian suppliers of textured breast implants to provide samples of their devices and information including how many products they have shipped. The working group plans to use the information to calculate the rates of BIA-ALCL for each type of implant.
TGA may take action, including the suspension or cancellation of particular devices, once it has that product-specific information. In the meantime, TGA has updated its advice to help women assess the benefits and risks of textured breast implants and look for signs and symptoms of BIA-ALCL after they are treated.
New Zealand’s Medsafe will be involved in all future meetings of the TGA working group. The agency has received six reports of BIA-ALCL.
, Medsafe Statement
CDSCO Discusses how to File Clinical Trial Applications Under new Rules
The Central Drugs Standard Control Organization (CDSCO) has discussed how the new Indian rules on clinical trials have affected regulatory filings. CDSCO still expects applicants to use the Sugam portal but has changed the details of what they should submit.
Under the new rules, CDSCO expects applicants that want to run clinical trials, perform bioequivalence studies or engage in certain other regulated activities to use the relevant checklist in Sugam to guide their submissions. Not all the steps can be done online, though. CDSCO wants applicants to fill in paper versions of the appropriate forms, scan them and upload the files to Sugam.
CDSCO has recently put the infrastructure in place for the revised process. The agency included the required forms in a notification about the new clinical trial rules and has made provisions in Sugam to handle the applications.
The new rules have also affected the fees applicants must pay. CDSCO has pointed applicants to the appropriate section of the rules and told anyone who needs further information to contact its IT help desk.
China Clears up Clinical Trial Safety Data Confusion in new FAQ Document
China’s Center for Drug Evaluation (CDE) has sought to clarify its clinical trial adverse event reporting requirements in a frequently asked question (FAQ) document. The text addresses areas of confusion that have arisen since the introduction of guidance on the topic one year ago.
CDE’s FAQ starts out clarifying basic points about the scope of adverse event reporting rules, such as whether the requirements apply to clinical trials of vaccines. Having clarified that sponsors of vaccine clinical trials must comply with the reporting rules, CDE goes on to address more specific questions about the application of the requirements to certain circumstances.
Specific questions include how companies that are yet to create pharmacovigilance systems capable of submitting reports in either of the requested formats can comply with the requirements. CDE is advising companies in this situation to outsource the work.
Another section of the FAQ deals with the division of responsibilities when reporting is outsourced to a contract research organization (CRO). The CRO can help with the submission of case reports, but the sponsor retains ultimate responsibility.
CDE plans to update the document as new issues arise.
India Again Calls for FDC Manufacturers to File Study Protocols or Data
CDSCO has again asked manufacturers of certain fixed-dose combinations (FDCs) to generate more data on the safety and efficacy of their products. The request affects 66 FDCs that came to market despite a lack of data showing they are rational, safe or effective.
Authorities have spent more than a decade working to resolve the status of hundreds of FDCs that came to market without the approval of the Drug Controller General of India (DCGI). In December, CDSCO sought to move the process forward by asking the manufacturers of 66 FDCs to submit clinical trial protocols or data by late February or early April, depending on the drug.
Both deadlines have now come and gone, but CDSCO has only received a “few” responses. The failure of the manufacturers to comply with the request has led CDSCO to send a reminder. Manufacturers have until the end of June to provide the requested materials.
CDSCO is threatening to rule on whether to permit the sale of the FDCs on the basis of the available information if the manufacturers fail to comply with the request. In the past, CDSCO’s threats have failed to have the desired effect, resulting in the FDC investigation and other regulatory initiatives taking longer than anticipated to complete.
DCGI Eswara Reddy sent the request to trade groups and state drug controllers on the same day as he issued a notice about the effect of the new clinical trial rules on the 83 FDCs deemed to be rational. Manufacturers of the FDCs must submit the fees specified in the new rules.
has registered a second drug under the Australia-Canada-Singapore-Switzerland Consortium’s work sharing initiative. The Australian agency and its Canadian counterpart independently approved Eli Lilly
’s cancer drug Verzenio after sharing responsibility for leading assessment of different parts of the application. TGA Notice
is seeking feedback on its response to the proliferation of different dosage forms based on Sanofi
’s off-patent cancer drug Eloxatin
. The branded product is sold as a freeze-dried powder, but Chinese companies have developed versions that do not require reconstituting, leading CDE to look into questions regarding dosage form selection and sterilization. CDE Notice
is probing a possible link between fluoroquinolone antibiotics and cases of aortic aneurysm. The agency is yet to receive reports of patients suffering aortic aneurysms in Australia as a result of taking one of the three fluoroquinolones sold in the country. Other countries have seen cases, though, prompting TGA to work with its international peers to formulate a local response. TGA Notice