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Asia Regulatory Roundup: China Releases UDI Rules as Pilot Progresses

Posted 03 September 2019 | By Nick Paul Taylor 

Asia Regulatory Roundup: China Releases UDI Rules as Pilot Progresses

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
TGA Seeks Feedback on Plan to List Excipients in Drug Products Online
 
Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on plans to list the excipients in medicines online. TGA is considering enforcing the change to give consumers access to information about the products they consume.
 
Today, the public version of the Australian Register for Therapeutic Goods (ARTG) displays the name of the active pharmaceutical ingredients in a medicine but lacks details of the excipients. TGA thinks this could cause problems for some consumers. Excipients have traditionally been defined as inactive ingredients, but there is now strong evidence showing they cause reactions in some patients. These reactions range from mild rashes to life-threatening side effects.
 
In light of the rising prevalence of allergies, TGA wants to equip consumers to review the ingredient lists of medicines, both to prevent side effects and to identify the possible allergens after an adverse reaction. That will require changes to the ARTG.
 
TGA proposes three paths forward in its draft consultation. Two of the paths mandate different levels of disclosure. One option is to publish the names of all excipients, except those used in proprietary flavor or fragrance ingredient mixes. The ARTG would display flavor and fragrance mixes by either their proprietary name and number, such as “PI1234 lemon flavor,” or by their purpose. None of the ingredients that make up the mixes would be named.
 
That option is in line with practices in Canada and New Zealand, plus the existing Australian approach to foods and cosmetics. However, TGA is also considering a second option that would extend the protection of proprietary mixes beyond flavors and fragrances. Under that option, “any combination of ingredients referred to as a proprietary ingredient mix” would be listed by their proprietary name or purpose. Other types of proprietary mixes include colors, printing inks and coating solutions.
 
In presenting that option, TGA notes that it would result in ongoing “significant gaps in publicly available information” and “continued misalignment with the approaches for food and cosmetics.” The approach may be more popular with industry than the full-disclosure option, though.
 
The third option presented by TGA is to retain the current system. However, as TGA notes, this option fails to address the concerns relating to allergic reactions that led the agency to propose the changes.
 
To guide its decision, TGA wants interested parties to say which option they prefer and why. TGA is also hoping to gather feedback on the risks and benefits of each option and gauge whether groups are interested in collaborating to help get excipient information to consumers.
 
TGA is accepting feedback until 10 October.
 
TGA Consultation
 
China Releases UDI Rules as Pilot Progresses
 
China’s National Medical Products Administration (NMPA) has published unique device identification (UDI) rules. The rules set out China’s approach to UDIs ahead of the implementation of the medical device system at the start of October.
 
UDIs issued in China will carry information about devices and their production. The identifiers must comply with the standards of a company’s chosen code agency and be uploaded to NMPA’s medical device registration system and a Chinese UDI database. Companies must update the information on the databases when their circumstances change.
 
The rules are intended to support the creation of a standardized UDI system. NMPA thinks putting such a system in place will strengthen medical device lifecycle management, improve the accuracy of information about products and ultimately benefit patient safety.
 
NMPA published details of the rules the day before sharing a report on its UDI pilot program. The report discussed the recent creation of a UDI working group to coordinate work on the pilot system. NMPA has begun training the more than 100 companies involved in the pilot.
 
NMPA Notice, More (both Chinese)
 
India’s NPPA Clarifies Knee Implant Price Caps Amid Market Confusion
 
India’s National Pharmaceutical Pricing Authority (NPPA) has clarified that hospitals and other health centers can add a trade margin to the price of orthopedic knee implants. NPPA issued a statement on the topic after learning that some third-party administrators (TPAs) are not allowing trade margins.
 
Knee implants came under price control in India two years ago. NPPA reviewed the situation in August 2018 and again earlier this month but largely retained the system it put in place in 2017. Despite that, the cost watchdog has learned that some TPAs, which serve as intermediaries between insurance providers and patients, are misinterpreting the rules.
 
NPPA learned of TPAs that are prohibiting hospitals from adding trade margins to the price of knee implants. The prices set in 2017 significantly restricted the margins hospitals could add to the prices of knee implants, which had run to more than 300% before NPPA acted, but still permitted facilities to charge more than they pay manufacturers for the products.
 
The latest notice from NPPA reiterates the situation in light of the reports of the TPA actions.
 
NPPA Notice
 
China Publishes Flurry of Vaccine and Drug Traceability Documents
 
Chinese authorities have released a flurry of documents relating to vaccine and drug traceability. The three documents detail the standards for traceability systems and data exchange.
 
Work on the traceability system began last year, but some of the key building blocks remained absent in the months after the initiative got underway. NMPA closed some of those gaps with the release of the three documents, which complement existing texts that provided guidelines on constructing a drug traceability system and the associated encoding requirements.
 
Shortly after the NMPA publication, China’s Center for Drug Evaluation (CDE) issued a draft text on another aspect of vaccine regulation. The draft covers post-approval changes to the production of vaccines. CDE is accepting feedback on the draft for one month.
 
NMPA Notice, CDE Notice (both Chinese)
 
TGA Details Response to Feedback From 2018 Stakeholder Surveys
 
TGA has published details of how it responded to the findings of stakeholder surveys it ran last year. The surveys identified six areas for improvement that TGA has used to inform its recent activities.
 
One theme to emerge from the survey was the need for TGA to provide faster, more helpful replies to enquiries. In response, TGA has adopted technology to help it track its customer service performance and compare it to its standards.
 
Acting on other pieces of feedback, TGA has reviewed its approach to prioritizing noncompliance cases, begun publishing medicines safety updates as they arrive and held face-to-face events and webinars.
 
TGA Statement
 
Other News:
 
CDSCO has deferred another fixed-dose combination (FDC) deadline. The latest delay pushes back the date on which manufacturers of 49 FDCs need to file clinical trial protocols. The delay also affects manufacturers of 17 FDCs that are supported by inadequate data. CDSCO originally asked companies to submit the requested materials by either the end of February or start of April, depending on the nature of the demand. The deadline, which was delayed once in April, has now been moved back to the end of September. CDSCO Notice
 
China’s CDE has responded to questions about submitting information relating to drug registration and inspection on CD-ROMs. The responses address 20 questions based on CDE’s interactions with the industry following the publication of the original guidance. CDE Notice (Chinese)
 
CDSCO has reminded companies of their obligations under an Indian apprenticeship law. CDSCO Notice
 

Tags: CDSCO, China, NPPA, TGA

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