Asia Regulatory Roundup: Lilly Sarcoma Drug Gets First Australian Provisional Approval

| 17 April 2018 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Eli Lilly Sarcoma Drug Gets First TGA Provisional Approval Determination
The Therapeutic Goods Administration (TGA) of Australia has granted its first provisional approval determination to Eli Lilly’s soft tissue sarcoma drug Lartruvo (olaratumab). Determination is the first step in the recently introduced regulatory approval pathway.
In awarding the status to Lartruvo, TGA has stated the monoclonal antibody is eligible for the pathway without guaranteeing it will receive provisional approval. The next step is for the drug to go through the premarket registration process, which can take up to 255 working days.
If TGA awards Lartruvo provisional approval at the end of that process, Lilly will gain clearance to market the drug for two years. TGA may award Lilly two extensions of two years each, giving it up to six years of provisional market access in total. Beyond that, Lilly will need to present enough safety and efficacy data to support the full registration of Lartruvo.
The timing of TGA’s awarding of the determination suggests Lilly engaged with the agency as soon as possible. TGA began holding pre-submission meetings with sponsors interested in the pathway in November and started accepting notices of their intent to file provisional determination applications the following month. With the determination process taking three to six months, April was the earliest a sponsor could receive the regulatory status. 
Lilly’s immediate interest in the pathway suggests it may find favor with sponsors, which have already embraced the priority review process TGA initiated through the same set of reforms. That status went live last year and has already attracted applications from AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson, Merck, Novartis and Roche. TGA has approved two Roche products through the priority review process and is due to rule on a handful of other drugs in the coming months.
TGA Notice
Regulatory Affairs Group Pushes for Inclusion in DCGI Quarterly Meetings
An Indian regulatory affairs group has asked to join Eswara Reddy’s newly instigated quarterly trade group meetings. The Drug Controller General India (DCGI) initiated the meetings shortly after taking power and limited participation to a small number of organizations.
Reddy left the Association of Regulatory Affairs Professionals (ARAP) off the list of groups allowed to attend the meetings, prompting the nonprofit to write to the DCGI. The letter welcomes Reddy’s decision to create a regular forum for discussions with industry groups and asks him to grant ARAP a seat at the table.
The initiation of the meeting agenda was one of Reddy’s first actions after taking over from Dr. GN Singh as DCGI. Reddy invited six groups to the meetings. The invited trade groups represent Indian drug research companies, bulk and finished-product manufacturers, entrepreneurs and small and medium-sized enterprises. None of the groups are specifically focused on regulatory affairs.
ARAP’s attempt to change that highlights one of the issues with Reddy’s meeting program. In forging closer ties with some trade groups to improve the flow of information between CDSCO and industry, Reddy has favored some organizations over others and potentially created an asymmetry in the availability of knowledge.
Reddy is yet to respond publicly to the request.
ARAP Letter
TGA Updates FAQ to Help Sponsors Comply With Revised Product Information Format
TGA has revised its frequently asked questions on product information reformatting to help sponsors comply with the requirements. The update to the text follows the release of a product information form last month.
The form published in March differed from the one TGA released ahead of the switch to the new format at the start of the year. That left some companies in the position of having reformatted their product information in light of the first form, only for the release of revised document to cast doubt on the validity of their applications.
TGA has addressed that doubt and other questions in a revised advice document. The text states sponsors that reformatted product information sheets prior to the release of the March form should not need to make further changes. However, TGA is advising sponsors in this situation to add a subheading on reporting suspected adverse events next time they update the product information.
That is one of three questions added to the document in the latest update. The other two summarize the differences between the forms published in November and March, and explain where to place the statement on biosimilarity. TGA wants sponsors to place the statement after the name of the active ingredient in the first section of the product information.
TGA has also updated its response to five existing questions. The updates clarify the process for making product information changes that are unrelated to formatting, expand on the product details sponsors should include on the title page and detail the best practices for cross-referencing.
TGA Notice
Vats Starts as New Part-Time Chairman of NPPA
Rakesh Kumar Vats has taken up the chairman role at India’s National Pharmaceutical Pricing Authority (NPPA). Vats will perform the leadership role while continuing to carry out existing duties within the Indian Administrative Services.
The Indian health ministry appointed Vats earlier this month, and he took up the position at the end of last week. Vats is an additional secretary in the Ministry of Health and Family Welfare and a director at state-owned condom manufacturer HLL Lifecare. The government has given Vats oversight of NPPA in addition to his existing responsibilities.
NPPA was without a leader for more than one month prior to the appointment of Vats. The vacancy was created when Indian authorities decided to reassign Bhupendra Singh to the National Authority of Chemical Weapons Commission. With the transfer coming before Singh’s term was up and after he had butted heads with various parts of the healthcare sector over drug and device prices, the move raised fears that India was neutering NPPA in the face of industry lobbying.
The appointment of a part-time replacement for a previously full-time role is likely to fuel the fears, which had already been increased by media reports in the wake of Singh’s departure. Quoting an anonymous Department of Pharmaceuticals official, Indian political publication ThePrint reported NPPA had focused too much on drug pricing under Singh. Going forward, NPPA will focus “on other critical functions such as data collection and market research.”
NPPA Post, The Economic Times, ThePrint
Other News:
CDSCO has appointed 108 drugs inspectors to its pre-revised pay structure. The employees took up the role of drugs inspector as far back as October 2016. All but three of the employees work at the CDSCO headquarters, which recently lost around 20 drugs inspectors in a shakeup following the departure of DCGI Singh. CDSCO Notice
TGA is seeking feedback on proposed amendments to the Poisons Standard. The Australian drug regulatory agency is considering moving 30 mg doses of codeine to a higher schedule to address an inconsistency in how it is regulated. Another proposed change would make sildenafil, the active ingredient in Viagra, available without a prescription. TGA Notice
The Drug Regulatory Authority of Pakistan (DRAP) has extended the deadline for submissions to win IT contracts. DRAP originally gave applicants 15 days to send sealed bids for the tenders for servers, software and other IT equipment when it posted the notice late last month. The revised notice sets the deadline at 23 April. DRAP Notice


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