Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Expands Medical Device Registration Pilot to Cover Multiple Regions
China’s National Medical Products Administration (NMPA) has expanded a medical device registration pilot project. The pilot project, which began in a free trade zone, will now cover 21 provinces to help NMPA accrue more experience of the medical device registration system.
NMPA is running the program as part of its efforts to establish an advanced medical device industry in China. The expectation is that the pilot will improve the use of resources in the device industry by facilitating effective outsourcing, while increasing the use of quality management systems.
To participate in the pilot, a medical device company must have operations in one of the provinces and possess certain capabilities. NMPA wants applicants to have full-time staff experienced in fields such as regulatory affairs and post-marketing oversight, a quality management system and ability to take responsibility for the quality and safety of medical devices.
These capabilities are required as participants in the pilot are expected to strengthen oversight of the facilities that manufacture their devices and increase their monitoring of adverse events. Ultimately, NMPA wants the whole device lifecycle, from R&D to materiovigilance, to be traced and monitored.
TGA’s Mooted Reforms to Generic Medicine Authorization Get Mixed Response
The medicine industry has provided a mixed response to plans to change the rules on generic drug authorizations in Australia, in part because of divergent feedback from manufacturers of branded and off-patent products.
Manufacturers submitted the feedback in response to a consultation initiated by the Therapeutic Goods Administration (TGA) in June. The consultation proposed reforms including new changes to the requirements to show that Australian and overseas reference products are identical. TGA hoped the proposed changes would reduce barriers for applicants seeking to register new generic drugs.
The Generic and Biosimilar Medicines Association (GBMA) welcomes the proposal, noting that the current requirement for generic medicines to be shown to be bioequivalent to the Australian reference product “sometimes results in products not being available for Australian patients.” GBMA’s branded drug equivalent, Medicines Australia, agrees that the change would reduce barriers for generic drugmakers but warns of unintended consequences including a reduction in quality and safety standards and the erection of barriers for other manufacturers.
“Concern has been expressed to Medicines Australia that reducing barriers to generic medicine market entry could make it commercially unviable for small innovator companies to register and launch in Australia and potentially deter them from entering the Australian market,” Medicines Australia writes in feedback to TGA.
TGA is seeking to find a middle ground. In response to the feedback, the agency is drafting regulatory changes that would loosen the bioequivalence requirements on lower-risk medicines under certain conditions. The requirements for higher-risk products will remain the same.
Divergent feedback on another proposal deterred TGA from the idea altogether. TGA proposed offering a fast track to the first generic version of a product or creating incentives to get multiple manufacturers to enter a market, thereby reducing the likelihood of shortages. GBMA says such incentives “have the potential to encourage activity that promotes a robust supply of medicines in Australia” but Medicines Australia is down on the idea.
“Medicines Australia cautions that providing incentives to increase the number of generic medicines in Australia may not solve issues around a robust supply of medicines in Australia, and may in fact lead to unintended consequences by further creating an unlevel playing field with regard to medicines registration and exacerbating the impact of existing pricing policies,” the trade group writes.
Faced with those responses, TGA has dropped plans to offer incentives, at least for now. Instead, TGA plans to “reduce Australian-specific requirements and create more efficient processes.”
CDSCO Registers 2 More Notified Bodies Under Medical Device Rules
India’s Central Drugs Standard Control Organization (CDSCO) has registered two more notified bodies under its Medical Device Rules 2017. The addition brings the number of notified bodies authorized to assess medical device operations under the rules up to six.
Through the rules that came into force last year, Indian state and central regulators assign notified bodies to perform certain tasks, such as confirming a company has a compliant quality management system and inspecting facilities that manufacture Class C and D medical devices. Around one year ago, CDSCO revealed it had designated four notified bodies to perform these tasks.
The latest update adds BSI Group India and BSCIC Certifications to the list of notified bodies. BSI is a multinational organization that became the first notified body to be designated
against the EU's medical device regulation earlier this year. BSCIC, which has its head office in Delhi, is the first Indian business designated under India's Medical Device Rules.
In the months after the rules came into force, there were reports that notified bodies felt the compensation offered by the government was insufficient. The reports raised concerns that the fee structure would deter notified bodies from signing up to handle the medical device work.
Australia Adopts Revised Therapeutic Goods Advertising Code
Australia has adopted an amendment to the Therapeutic Goods Advertising Code. The clarifications exempt advertisements that are part of public health campaigns from the requirements of the code and updates the health warning definition to ensure patients know the risks of using a product.
The potential overlap between adverts and public health campaigns has been a topic of debate over the recent rounds of revision to the code. Last year, Medicines Australia objected to plans to prohibit disease awareness campaigns from naming a “specific therapeutic good or sponsor either expressly or by implication,” leading to a change to the text.
Now, Australian legislators have added a line stating that the code does not apply to an advert that is “part of, or otherwise comprises, a public health campaign.” The exemption joins adverts directed exclusively to health professionals on the list of promotions outside of the scope of the code.
Other changes include the adoption of a new definition of the term health warning. The previous definition was brief, defining a health warning as a required statement on product labels about the risk of death, hospitalization or outcomes that require the involvement of a medical practitioner.
The new definition features new subsections, including a statement about needing to alert patients to circumstances in which they should not use the product, such as pregnancy. Legislators think the changes will help to protect patients from harm.
“The purpose of these clarifications is to ensure that this important information about the potential impact on a person’s health from using or taking these kinds of goods will be available for consumers to inform their selection of these goods,” the government writes in an explanatory statement.
Another change to the code deals specifically with pregnancy. Due to changes in the way “a serious form of a disease, condition, ailment or defect” is defined in the new code, pregnancy was captured by that term. That would have made pregnancy a restricted representation, requiring companies to get TGA approval before claiming that a product achieve outcomes such as preventing pregnancy.
The government felt that would be “an unnecessary regulatory burden and inconsistent with the objectives of the restricted representation requirements,” leading it to make other changes to the code to clarify its intentions.
, Legislative Changes
, Explanatory Statement