Asia Regulatory Roundup: TGA Tweaks Plan to Increase GMP Fees

Regulatory NewsRegulatory News | 22 May 2018 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Tweaks Plan to Increase GMP Fees and Charges After Industry Rejects Proposals
The pharmaceutical industry has pushed back against plans to increase the fees and charges associated with good manufacturing practice (GMP) regulatory processes in Australia. The country’s Therapeutic Goods Association (TGA) tweaked and delayed its proposals in response, but is pushing ahead with the plan in a modified form.
TGA proposed changing its GMP fee structure earlier this year after identifying areas where there is undercharging. To make the system fairer and ensure it recovers its costs, TGA and consultancy Deloitte created new charging structures and put three options to the industry. Deloitte expressed its preference for the third option, which called for TGA to stop providing “free” inspection hours and combine the low and high licenses into one annual charge.
Medicines Australia, a trade group representing Novartis, Pfizer and other large, multinational companies, led the criticism of the proposals, declining to support any of the three options put forward by TGA. The trade group also accused TGA of failing to take the financial planning cycles of global companies into account by proposing to hike fees after most businesses have set their budgets for 2018 to 2019.
TGA has adapted its plan in light of some of the criticisms. The new plan calls for GMP clearance fees to increase slightly in July, before ramping up more significantly midway through 2019. That delay addresses Medicines Australia’s concerns about the lack of notice given for the price increase.
The agency also lowered the 2019 GMP clearance fee from AU$790 ($594) to AU$640, making up the difference by raising the compliance verification fee from AU$2,030 to AU$2,430. Medicines Australia suggested changing the two fees to “avoid cross subsidization.”
However, TGA has opted against enacting other recommendations made by the trade group. In its feedback, Medicines Australia called for TGA to tie the fee increases to commitments to improve the service it provides.
“Basic customer service standards such as defined times for replies to queries and clear routes of communication should be introduced and monitored,” Medicines Australia wrote. “Improved services may also help to mitigate increased cost associated with a changed GMP fee structure by reducing time industry personnel spend on follow-up to queries and reduce difficulties in planning associated with uncertain timeline for processing and decision making.”
Medicines Australia also called for TGA to cut costs by collaborating more with its international peers and questioned whether the agency is overcharging in some areas. The trade group raised the idea that TGA has been overcharging after the agency disclosed its current fees are too low to fully fund the GMP service, suggesting it is transferring money from elsewhere to support the unit.
individual drug companies including AbbVie, Bristol-Myers Squibb and GlaxoSmithKline also voiced concerns, of varying degrees of severity, with the proposals. AbbVie joined Medicines Australia in rejecting all the proposals and questioning whether increasing the fees would lead to an improved service.
“The GMP clearance section is obviously under resourced and any additional revenue should lead to more staff to deal with the number of GMP applications, but given the cap of number of [full-time equivalents] in the department, this is unlikely scenario,” AbbVie wrote.
MA Response, All Feedback
India Creates Checklist to Help Herbal Drug Firms Apply for WHO GMP Certificates
The Central Drugs Standard Control Organization (CDSCO) has created a checklist to help producers of herbal medicines meet GMPs. CDSCO’s checklist covers the documents companies need to provide to the World Health Organization (WHO) to gain GMP certificate of a pharmaceutical product (CPP).
The draft text lists 22 documents, plus some data classed as subdocuments, manufacturers of herbal drugs need to submit to gain a CPP. The list includes certificates of analysis for three batches of each product, the manufacturing plant layout and other detailed requests alongside basic information such as the name of the applicant.
CDSCO has also attached blank tables manufacturers can use to submit data. Manufacturers can use the tables to file stability data, from both accelerated and real-time studies, and information needed for product summary sheets. 
Publication of the draft checklist comes at a time when India is trying to grow its herbal medicine industry. India has a long history of herbal medicine use but Chinese practice is better established globally. Narendra Modi committed to promoting the Indian herbal medicine sector after being named Prime Minister, leading to the creation of the Ministry of Ayush and this week’s checklist.
CDSCO is accepting feedback on the draft checklist until the end of the month.
CDSCO Checklist
China Makes Bribery in Medicine a Focus of Drive to Ensure Fair Competition
China’s State Administration for Market Regulation (SAMR) has made the medical field a focus of its fair competition agenda. The action means SAMR will pay particular attention to the sector as it promotes the implementation of the Anti-Unfair Competition Law in the coming months.
The law, which came into force at the start of 2018, has a broad scope spanning bribery, trademark infringement and other unfair practices across all industries. To support its implementation, SAMR is spending the next six months focusing on what it sees as key aspects of the law and its potential to level the playing field in Chinese business.
Medicine is one of the target areas. SAMR wants to ensure purchases and sales of drugs and medical equipment are performed fairly. Types of malpractice targeted by SAMR include the use of property or other assets to bribe people and actions intended to secure trading opportunities or competitive advantages.
China has cracked down on bribery in the pharmaceutical sector in the past, leading to the arrests of executives and penalties totalling hundreds of millions of dollars.
SAMR Notice (Chinese)
India Changes Membership of Drugs Technical Advisory Board
India has revised the membership of the Drugs Technical Advisory Board (DTAB). The new look board has the same legislatively-enforced structure as before but features new faces in many of the roles.
DTAB, which advises the government, is made up of eight people whose seat on its the board stems directly from their job, such as the the Drugs Controller of India, and 10 who are nominated or elected by various bodies. The people nominated and elected to these positions in 2014 are now being replaced.
The new members of the board include Pankaj Patel, chairman of Zydus Cadila, who is taking up the one industry seat. Sudhir Mehta, chairman of Torrent Pharmaceuticals, used to hold the industry seat on the board.
A mix of state-level regulatory officials, academics, pharmacologists and others occupy the other seats. 
Gazette Notification
Other News:
TGA has updated its drug labelling guidance in response to feedback. The latest version of the text addresses comments received over the past two years, while also adding information about latex labelling and Schedule 1 substances. TGA Guidance
The State Drug Administration (SDA) of China has released details of the medical device standards it plans to update this year. The list is based on suggestions submitted by the public. SDA Notice (Chinese)
China’s SDA has released rules intended to strengthen the confidentiality of information related to drug reviews and approvals. SDA Notice (Chinese)


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