Asia Regulatory Roundup: TGA Proposes Fee Changes to Offset Increase in Costs

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
TGA Proposes Fee Changes to Offset Increase in Costs
 
Australia’s Therapeutics Goods Administration (TGA) is planning to raise its fees and charges to offset a forecast AU$7 million ($4.8 million) spending increase. TGA’s preferred option is to increase all fees by 1.95%, an indexation factor calculated by looking at changes in wages and consumer prices.
 
In the 2020 to 2021 financial year, TGA expects spending on staff and contractors to grow by AU$3.8 million. Other non-discretionary costs linked to software installed in response to the Medicines and Medical Devices Regulation Review and corporate charge back are set to further add to expenditures, bringing the projected growth in TGA spending up to AU$7 million.
 
TGA is unlikely to be able to rely on increased volumes to drive the increase in revenue necessitated by the growth in spending. After years of steady growth in the number of products on the Australian Register of Therapeutic Goods (ARTG), the trend reversed in the 2018 to 2019 financial year.
 
“While this decline was a result of rationalization of medical devices and complementary medicines, little or no growth is projected in annual charges revenue in the coming year. Additionally, the revenue foregone due to the Annual Charge Exemption (ACE) scheme continues to be significant,” TGA wrote. TGA expects to forego AU$41 million in the current fiscal year as a result of ACE.
 
Other recent changes are also putting pressure on TGA’s finances. TGA pointed to a significant rise in fee-free services, in large part due to demand for medicinal cannabis, as a driver of spending growth that it is unable to recoup. The agency also highlighted a more than 400% year-on-year increase in notifications tied to medicine shortages as another cause of more spending. The jump came after the Medicine Shortages Information Initiative went from being a voluntary to mandatory initiative.
 
TGA calculates it would need to increase fees and charges by 4.3% to cover the additional spending. However, a 4.3% increase is not TGA’s preferred option as it sees such a change as “inconsistent with the long established indexation practice,” adding that it “may compromise certainty for sponsors and manufacturers.”
 
Rather, TGA wants to limit the increase to the 1.95% indexation factor, as it is consistent with prior practices and “provides opportunities for efficiency gains through business process improvements.” TGA increased fees and charges by more than the indexation factor for the 2012 to 2013 fiscal year but typically ties its rates to the inflation-linked index.
 
The third option is to keep the fees and charges at their current levels. However, TGA thinks doing so would force it to significantly reduce staff levels, leading to negative knock-on effects on its ability to process applications on time and implement its regulatory reforms program.
 
In addition to the across-the-board fee increase, TGA is planning to make bigger, targeted changes. For example, TGA intends to introduce a fee of AU$8,500 for providing early scientific advice related to generic medicines. TGA is currently unable to provide such a service but expects new legislation to grant it that power.
 
TGA is accepting feedback on the proposal until 28 February.
 
TGA Consultation
 
TGA Establishes 5-Year Plan to Build Regulatory Science Capability
 
TGA has set out a five-year plan to build its regulatory science capability. The strategy calls for TGA to begin initiatives to attract, train and retain talent while improving collaboration and communication with third parties.
 
With health products becoming more complex, the Health Products Regulation Group (HPRG), which is made up of TGA and the Office of Drug Control, looked into how to establish the regulatory capabilities to thrive in this operating environment. The result is a five-year strategy built around four key areas, the first of which covers how to maintain and build skills in regulatory science.
 
HPRG is planning to create a Regulatory Science Capability Framework (RSCF) to support the skills part of the strategy. RSCF will “identify the capabilities needed for regulatory scientists” and serve as a resource that managers can use for team development and individuals can use to plan their careers. 
 
A formalized, voluntary Continuing Professional Development (CPD) program will complement RSCF. HPRG sees CPD helping regulatory scientists stay abreast of technical knowledge and developments relevant to their work. A working group is set to develop formal outcomes for people who participate in CPD, enabling them to get recognition for the proactive learning they undertake.
 
The planned activity of the CPD working group is one of several areas of the strategy that is at the idea stage. To turn the ideas into actions, HPRG plans to identify high-priority initiatives, figure out measures of success and create timelines for implementing the changes.
 
TGA Report
 
CDSCO Tasks Indian States With Managing Approval of 450 FDCs
 
India’s Central Drugs Standard Control Organization (CDSCO) has sent a notice about 450 fixed-dose combinations (FDCs) deemed to be rational by a committee tasked with assessing the products. CDSCO wants state regulators to contact affected manufacturers and ask them to seek approval.
 
In December 2018, CDSCO asked state regulators to contact the producers of close to 1,700 rational FDCs. However, that list left off 450 FDCs now deemed to be rational by the Kokate Committee.
 
The latest notice brings the 450 FDCs to the attention of state regulators. CDSCO wants regulators to contact the manufacturers of the FDCs and ask them to follow a pathway to get a product license. The process entails submitting a fee and information including data from stability studies.
 
Assuming the conditions for approval are met, state regulators will issue licenses without seeking a no-objection certificate from the Drug Controller General of India (DCGI). The DCGI wants state-level regulators to ensure no FDCs other than those deemed rational receive product licenses.  
 
CDSCO Notice
 
China Updates API Registration System in Light of Revised Rules
 
China’s Center for Drug Evaluation (CDE) has updated its registration system for active pharmaceutical ingredients (APIs). The update follows the adoption of changes intended to improve the review and approval of drugs.
 
In response to the changes to the approval process, CDE has tried to improve the API registration system while updating the associated registration form and administrative license documents. Using the new CDE system, manufacturers of APIs can register their products, manage tasks related to the importation of ingredients for use in drugs sold in China and file for review and approval.
 
The changes come six months after China’s National Medical Products Administration (NMPA) set out how changes to drug review and approval will affect API manufacturers. NMPA’s guidance touched on the need for APIs to be covered by drug production licenses and an associated registration system. The NMPA text covered all APIs developed, manufactured and imported into China.
 
Efforts to reform the system date back to a 2017 announcement about APIs and excipients.
 
CDE Notice (Chinese)
 
Other News:
 
TGA has extended the deadline for the submission of feedback on its draft standards for fecal microbiota transplants (FMT). The comment period will now close at the end of the month. Under the original timeline, TGA aimed to finalize the standards this month, setting it up to begin a 12-month transition to the new requirements for manufacturers of FMT products. TGA Notice