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Asia Regulatory Roundup: Australia, Canada Add NCE Applications to Regulatory Work-Sharing Agenda

Posted 24 April 2018 | By Nick Paul Taylor 

Asia Regulatory Roundup: Australia, Canada Add NCE Applications to Regulatory Work-Sharing Agenda

The Australian Therapeutic Goods Administration (TGA) has started a new chemical entity (NCE) work-sharing pilot with Canada’s drug regulator. TGA and Health Canada will divide up the task of reviewing NCE filings in an attempt to reduce their workloads and those of applicants. 
 
Australian and Canadian officials are entering into the pilot project as part of the ACSS Consortium they participate in alongside the Singaporean and Swiss drug agencies. The project may expand to include all four agencies down the line but for now it is seeking applications from companies that want to file in Australia and Canada simultaneously.
 
Upon receipt of a common submission, TGA and Health Canada will divide up the work. Each agency will evaluate its respective Module 1 and process Module 5, which covers clinical matters, separately. The division of labor centers on Modules 3 and 4. Health Canada will evaluate the quality-focused Module 3, while TGA will take the lead on the toxicology-skewed Module 4.
 
TGA and Health Canada want applicants to include common information in Modules 2 to 5 but will allow some differences provided they are clearly highlighted prior to submission.
 
The pilot will give the two ACSS members a chance to start figuring out how single assessments will work in practice. Each agency will make the ultimate approval decision for its jurisdiction but the review that supports the ruling will feature contributions from its counterpart as well. As the NCE-focused working group gains confidence in the approach, work sharing will expand to encompass Singapore and Switzerland.
 
ACSS sees the creation and expansion of the NCE work-sharing model yielding multiple benefits. The approach potentially cuts the time and  effort involved for sponsors and agencies to complete the submission and review of approval filings, resulting in drugs reaching patients in medium-sized markets sooner. 
 
News of the NCE pilot comes months after ACSS expanded its generic drug work-sharing agreement. That initiative also went through a pilot test. The application assessed in the pilot took almost twice as long as expected to process. However, with the pilot suggesting ways to improve the process and the review still taking less time than Canada’s and Switzerland's standard regulatory pathways, ACSS is opening up the work-sharing option to more generic companies.
 
TGA Notice
 
India to Make Oxytocin Manufacturers Implement Track-and-Trace Systems
 
India is planning to make producers of oxytocin implement track-and-trace systems. The proposal follows years of partly-successful efforts to curb misuse of the hormone by dairy farmers.
 
If passed, the legislation will require the addition of 2D barcodes to oxytocin primary, secondary and tertiary packaging. These barcodes must encode “unique and universal global product identification code” that follows the 14-digit Global Trade Item Number format. Indian legislators expect all three levels of packaging to convey the batch number, expiry date and unique serial number.
 
These requirements are intended to facilitate the tracking and tracing of oxytocin products. To ensure that happens, manufacturers will have to maintain data across all levels of packaging in the parent-child relationship and upload the information to a government portal before releasing a product. The onus is on manufacturers to ensure the data uploaded are correct, complete and timely.
 
Manufacturers have 45 days to raise objections or submit suggestions related to the proposal, which has already been through a consultation process. The Central Drugs Standard Control Organization (CDSCO) met with oxytocin manufacturers earlier this year and proposed adopting a barcoding system shortly thereafter. CDSCO gave manufacturers 15 days to comment on that proposal.
 
Gazette Notification
 
TGA Highlights Common Errors in GMP Clearance Filings to Prevent Delays
 
TGA has alerted companies to common mistakes they are making in good manufacturing practice (GMP) clearance filings. The publication comes seven months after TGA revised the filing process to tackle the prevalence of incomplete submissions and thereby reduce its workload.
 
This week’s update suggests that effort has only been partly successful. The update highlights three areas of the revised process that applicants are getting wrong, starting with requests for new manufacturing sites. TGA is advising companies to search the list of registered manufacturers before asking for a new producer or site to be added. Companies only need to make a request if the firm or site are not listed on the register.
 
The inability of some companies to follow this process creates problems for TGA and the applicant. Applicants that unnecessarily add manufacturing plants may face delays when they come to request variations and have to update Australian Register of Therapeutic Goods entries down the line. 
 
TGA issued an even stronger warning related to the second type of error it is seeing. The agency has received submissions that select the wrong application type, most commonly by choosing TGA GMP Certificate or Compliance Verification rather than MRA. The MRA option covers manufacturers in countries with which TGA has a mutual recognition agreement. Selecting a different option can lead to “significant delays” and the loss of application processing fees, TGA warned.
 
Applicants that make the third common error discussed by TGA also risk losing their fees. These firms are failing to provide all the required evidence, in many cases by not submitting sponsor-specific evidence to support a letter of access.
 
Collectively, the errors are hindering TGA’s ability to quickly process GMP clearance applications. The number of applications received by TGA has increased by more than 100% since 2010. Prior to the regulatory changes made last year, the agency chased up the 60% of applicants that failed to submit complete filings. TGA has since hardened its approach to incomplete applications as part of the changes designed to ensure companies file all the information first time. 
 
TGA Notice
 
Australia Clarifies Regulatory Status of Medical Devices Containing Poisons
 
TGA has released a guide detailing the regulatory requirements for medical devices that contain poisons. Class III medical devices are generally exempt from the requirements of the drug-focused Poisons Standard but certain types of products fall within its scope.
 
Broadly speaking, the products covered by the Poisons Standard feature non-device components, such as anticoagulants or collagen. However, not all such products are required to comply with the standard. For example, orthopedic bone cements that feature Schedule 4 antibiotics are covered by the exemption for Class III devices.
 
TGA has released the guide to walk companies through when a device is subject to the requirements of the Poisons Standard and what obligations this places on them. The guide uses the examples of a synthetic dermal filler containing lidocaine and hydroxyapatite and a synovial fluid supplementation substance containing hyaluronic acid and gentamicin to explain the rules.
 
The goal is to help manufacturers understand how they can comply with the rules. TGA plans to update the guide over time and is accepting feedback to inform the evolution of its advice.
 
TGA Guidance
 
Other News:
 
TGA has released a tool to help sponsors determine whether the clinical trial notification or exemption scheme (CTN/CTX) is most appropriate for their studies. The tool asks a series of questions, such as ‘does the trial involve a therapeutic good, to help lead sponsors in the right direction. Filings under CTX are evaluated, while CTN is simply a notification scheme. TGA Tool
 
China’s drug agency has issued a notice about recruiting staff. Notice (Chinese)

Categories: Regulatory News

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