Asia Regulatory Roundup: TGA Signs up for Pilot Project to Harmonize Medical Device Submissions (29 September 2015)

Regulatory NewsRegulatory News | 29 September 2015 |  By 

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

TGA Signs up for Pilot Project to Harmonize Medical Device Submissions

Australia's Therapeutic Goods Administration (TGA) has joined a pilot project to harmonize the electronic submission format for the premarket evaluation of medical devices. TGA's participation in the pilot means companies can now use the Table of Contents (ToC) structure for supporting data when filing applications for conformity assessment with the Australian regulator.

The idea behind the pilot project, which is being run by the International Medical Device Regulators Forum (IMDRF), is to assess how the ToC structure handles real submissions. IMDRF has spent more than four years working on structures for in-vitro diagnostics and other classes of medical devices, but to date has only applied the model to historical submissions. The utility of the tests was limited by a lack of submissions covering multiple regulatory jurisdictions and their historical focus.

A 12-month pilot project is intended to overcome these limitations. IMDRF is encouraging medical device manufacturers to file submissions using the ToC structure to multiple regulators that are part of the pilot project. TGA is now in line to start receiving such applications. The regulator is still working on Australia-specific guidance for applicants, but is already inviting companies to use the ToC structure in their filings.

TGA and its collaborators see the structure as a way to make submissions less burdensome for the industry through harmonization, while also simplifying their own processes. The Australian regulator is viewing the uniform structure as a way to make its own operation more efficient. Whether the ToC structure can meet these expectations in its current form — and if not, what changes are needed —  should start to become clearer as companies use the model for active, real-world regulatory filings.

IMDRF plans to survey industry and regulatory participants in the pilot project. The main objectives of the industry survey are to ascertain how companies found the process of using the ToC headings and classification matrices and how easy it is to adapt content for filings to multiple regulators. From regulators, IMDRF wants to learn whether companies submitted complete applications or made any changes to the ToC structure and organization.

TGA Notice, IMDRF Pilot Plan

CFDA Joins Collaborative Crackdown on Performance-Enhancing Drugs

China Food and Drug Administration (CFDA) has committed resources to a collaboration to stop the spread of performance-enhancing drugs (PEDs). The alliance is a response to rising recognition of the central role China plays in the production and proliferation of PEDs.

The participation of CFDA in an attempt to improve the situation is the result of a Memorandum of Understanding between the World Anti-Doping Agency (WADA) and the General Administration of Sport of China (GASC). With neither WADA nor GASC having the power to stop the spread of PEDs, the partners are setting up a project team that will bring together officials from CFDA with members of the police force, customs operation and the Chinese Anti-Doping Agency (CHINADA).

To David Howman, director general of WADA, the value of CFDA's involvement is clear. "There is tremendous potential in sharing information and investigating the trafficking of doping substances — with organizations that have the power to reduce and eliminate the illegal manufacture and supply of PEDs and raw materials that result in PEDs — in a country that faces a problem with the illegal sale and exportation of banned substances," Howman said.

Howman envisions information flowing into and out of China. WADA and Interpol will share details of PED operations in China with CFDA and local law enforcement officials to enable them to stop supplies at the source. Officials at WADA have gleaned such information from the US Drug Enforcement Administration (DEA)'s Operation Cyber Juice and other initiatives, which have identified Chinese manufacturers that sell PEDs, and raw materials used in their production, online.

WADA is also looking to CFDA and other units of the Chinese government to provide information on PED supplies. The expectation is that the spread of this information will enable officials in other parts of the world to investigate and arrest buyers of PEDs. Operation Cyber Juice hinted at the scale of the investigations that could follow. The five-month DEA probe resulted in raids on 16 labs, 90 arrests across 20 states and the seizure of 1,400 pounds of steroid powder. 

Press Release, Reuters

Malaysia Floats Plan to Simplify Medical Device GDP Certification Process

The Malaysian Medical Device Authority (MDA) is planning to change the regulatory requirements covering good distribution practices (GDPs) for medical devices to simplify the information covered by certificates.

If the proposal is unchanged following the brief public consultation held by MDA, the table used in GDP certification to list the medical devices handled by an establishment will change. Currently, the table covers eight pieces of information about each device, such as the product's name, Global Medical Device Nomenclature (GMDN) code and manufacturer. The revised table only covers five pieces of information about each device.

MDA plans to eliminate the need to provide details of each medical device's name, manufacturer code and registration number. Members of MDA's medical device GDP task force have already approved the amendment to the original regulatory document from 2013 but the industry could still object. The proposed change, while small in scope, has triggered the need for a short comment period, which ends on 1 October.

MDA Notice, Proposed Change, Scrip Regulatory Affairs

Other News:

The Indian government has set up a six-person panel to probe the case against GVK Biosciences. Members of the panel toured GVK's facility this week as part of an investigation that will give an opinion on the validity of the accusations and punishments faced by the testing lab. "The panel wants to find out whether the allegations are true or not," a politician said. The Times of India

Members of the All India Organisation of Chemists and Druggists (AIOCD) are planning to strike in protest against moves to allow the sale of prescription drugs online. AIOCD has 750,000 members. The plan is to have all of the retail and wholesale pharmacies represented by AIOCD remain closed on 14 October. AIOCD is lobbying through political channels against online sales, too. PharmaBiz

The Indian Pharmacopoeia (IPC) is holding a one-day workshop in October to discuss the quality and regulation of medicines. IPC officials will give talks on the effective use of working and impurity standards, while representatives of the Central Drugs Testing Laboratory and Central Drugs Standard Control Organization will discuss regulatory matters and IPC's role in drug quality. Workshop Agenda

Japan's Ministry of Health, Labour and Welfare (MHLW) has trimmed the list of applications that may be eligible for its accelerated review process down to 50 candidates. The fast-track pathway, dubbed "sakigate," will halve the time taken for clinical trial consultation and review. To qualify, the product must be due to come to market in Japan before it does so elsewhere. FiercePharmaAsia

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has posted a safety alert about the use of sodium valproate in pregnancy. Use of sodium valproate, which is sold under the brand name Epilim, while pregnant is associated with a greater risk of congenital malformation. Medsafe is advising against the use of Epilim in women of childbearing age. Medsafe Alert


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy