Asia Regulatory Roundup: CFDA Expands Trial Data Quality Monitoring Drive to Cover Medical Devices (11 July 2017)

Regulatory NewsRegulatory News | 11 July 2017 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Boehringer, J&J Pressure TGA to Bring ‘Out of Date’ Advertising Framework into Digital era

Boehringer Ingelheim and Johnson & Johnson have called for the Australian regulator to bring its advertising framework into the digital era. The Therapeutic Goods Administration (TGA) stands accused of operating an out-of-date framework that has failed to adapt to the rise of advertising on digital media and devices.

J&J and Boehringer shared their critiques of the current framework as part of a consultation on changes to how drug advertising is regulated in Australia. The consultation did not refer directly to the change in how companies advertise therapeutics, but Boehringer and J&J both used the call for comment as an opportunity to express their concerns with the modernity of the framework.

“We are of the opinion that the current advertising framework ... is now out of date and requires revision to incorporate more specific considerations of advertising medicines using emerging types of digital media and devices,” J&J wrote in its feedback.

J&J wants TGA to bring the framework in line with modern advertising practices and then update it every two to three years to ensure it keeps pace with changes in the industry it regulates. Adopting that review timeline would mark a major shift from historic practices. TGA last conducted a major review of its practices 20 years ago.  Since then, Boehringer has seen little in the way of initiatives to bring practices up to date.

“While there have been some business reforms within the TGA, there have not been any notable changes,” the German drugmaker said.

Some of the changes TGA has made have created confusion. J&J brought up TGA’s use of terms not common in the industry such as “internet marketing” as one problem. The company wants TGA to align its terms and definitions to those used by the industry as part of a push to ensure the rules are less open for interpretation. J&J is also calling for the publication of a guideline to further clarify TGA’s meanings and intentions.

Other companies joined Boehringer and J&J in pressing for more clarity and the adaptation of the framework to modern practices. Medtronic called for TGA to clarify its definition of advertisement in light of the shift away from broadcast and print promotion. Today, people look for healthcare information online and approach companies directly on social media. Medtronic thinks problems could arise from the perceived failure of the TGA framework to address this change.

“In the absence of regulated, compliant and comprehensive local information, there is a risk that Australian consumers will access information from international sites which at best may not be compliant with the Australian approved usage, and at worst, may be deliberately misleading and potentially dangerous,” Medtronic wrote.

Boehringer and J&J were two of about 50 people and organizations to provide feedback. TGA sought the feedback to shape how it handles complaints about advertising and implements other related reforms triggered by the Expert Review of Medicines and Medical Devices Regulation. One outcome of the process is TGA will take responsibility for handling complaints from 1 July 2018.

Boehringer, J&J, Medtronic, More Feedback, Regulatory Focus

CFDA Expands Clinical Trial Data Quality Monitoring Drive to Cover Medical Devices

China Food and Drug Administration (CFDA) has expanded its clinical trial data monitoring push to cover medical devices. The expansion will see CFDA form a team to perform on-site inspections of medical device clinical trial sites later this month.

CFDA has previously used regulatory documents to indicate its intent to step up on-site oversight of medical device trials. Now, the agency is preparing to put those plans into action. The formation of an inspection team is penciled in for late July, beyond which CFDA will start informing clinical trial institutions in writing of its plans to assess their operations.

The agency wants to run inspections to assess the traceability and authenticity of data generated to support the approval of medical devices. Just as when CFDA sought to reduce its backlog of drug approval applications, the agency is giving medical device companies the chance to pull filings if they think their data is inauthentic or their trials suffered from other serious compliance failings.

CFDA’s push to ensure the quality of data used to support medical device filings builds on two of its top priorities of recent years. Over that period, CFDA has sought to raise the standard of generic drugs sold in China by weeding out applicants seeking approval on the basis of compromised data. In parallel, CFDA has published a raft of documents to overhaul the regulation of how medical devices are developed and manufactured in China.

CFDA Notice (Chinese)

TGA Switches from wet ink to Electronic Signatures for Certificates of GMP Compliance

TGA has switched from wet ink to electronic signatures on all its licenses and certificates of compliance with good manufacturing practices (GMPs). The change means the Australian regulator has stopped issuing hard copy documents and including signature blocks on its certificates.

Officials will instead send PDF copies of licenses, certificates and covering decision letters via email. Licenses and certificates will no longer feature a signature block. The block remains on covering decision letters but will only show the name of the delegate or authorizing officer.

TGA made the change following the removal of its exemption from Australian legislation on electronic transactions. That removal prompted TGA to review whether any legislation requires it to provide wet ink signatures on licenses and certificates. Having concluded no such requirement exists, TGA has switched to electronic signatures for certificates and licenses.

This brings practices related to the documents in line with those already in place for decision letters, conformity assessment certificates and certificates of analysis. The switch also positions TGA to transition to an online self-service model in the future.

TGA is advising companies to check their email addresses are up to date to ensure they receive the PDFs via email.

TGA Notice

India Ends Emergency Action Forcing Manufacturers to Increase Output of Rare Disease Drug

India’s Department of Pharmaceuticals (DoP) has ended the emergency action it took to end the shortage of a rare disease drug. The decision not to continue forcing manufacturers to increase their production of the Wilson’s disease drug follows the improvement of levels of supply.

DoP originally imposed the requirements on manufacturers in December and renewed the action three months later. The invocation of the legislative power forced companies that manufacture the active pharmaceutical ingredient (API) penicillamine and finished products containing the API to report their production plans, capacity and sales to Indian regulators.

The burdens imposed by DoP included the requirement for API manufacturers to submit a weekly report of API delivery and production plan for the coming week to the National Pharmaceutical Pricing Authority. After six months, DoP has lifted this and other requirements.   

DoP Letter

Other News:

TGA has published an overview of the rules of its special access scheme. The scheme enables the import and supply of unapproved therapeutics needed by individual patients on a case-by-case basis. TGA Page

The New Zealand Medicines and Medical Devices Safety Authority has released an alert about the use of tramadol during breastfeeding. Medsafe Statement


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