Asia Regulatory Roundup: China Approves First Locally Developed Anti-PD-1 Checkpoint Inhibitor

Regulatory NewsRegulatory News | 18 December 2018 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
New Zealand Seeks Feedback on Replacement for ‘Inflexible’ Therapeutic Legislation
The New Zealand government is planning to replace decades-old legislation that it thinks is “dated, inflexible and prescriptive.” In replacing the legislation, New Zealand is seeking to expand the range of products it covers, harmonize with global standards and facilitate easy updates in the future.
New Zealand officials identified significant shortcomings with the Medicines Act 1981 within 10 years of its creation, but early efforts to reform the legislation centered on the proposed creation of a joint regulatory agency with Australia. When New Zealand stopped working toward the creation of a joint regulatory agency in 2014, it began looking into the drafting of a new Therapeutic Products Bill.
A draft version of that bill is now open for consultation. The legislation is designed to ensure that the requirements in New Zealand are consistent with international approaches and that the country can “recognise work done by trusted overseas regulators.”
The government also wants to create legislation that is easier to maintain and update. That desire is underpinned by the government’s experience with the Medicines Act 1981. In contrast with most modern legislation, the 1981 text covers regulatory requirements in considerable detail, rather than relying on more focused subordinate regulations, rules and notices to convey the specifics. The government thinks this has made it hard to update the text, resulting in it becoming outdated.

In the pursuit of a more flexible system, the government has restricted the revised legislation to the conveyance of principles to guide the New Zealand Medicines and Medical Devices Safety Authority as it the creates regulations, rules and notices that will cover the details.
New Zealand is accepting feedback on the draft until 18 April.
Government Consultation, Draft Legislation
TGA Floats Changes to Oral Drug Rules to Cut Regulatory Burden, Increase Harmonization
Australia’s Therapeutic Goods Administration (TGA) is planning to change its quality standards for oral tablets and capsules. The revisions are intended to decrease regulatory burdens and increase harmonization, for example by allowing manufacturers to comply with either Australian standards or one of the British, European and United States pharmacopoeias.
When the document, TGO 78, came into force in 2008, it set minimum quality standards for oral tablets and capsules sold in Australia. TGA recently began consulting with industry on whether TGO 78 is effectively and efficiently achieving that goal ahead of the legally mandatory sunsetting of the document in April. Under the terms of Australian law, TGA needs to ascertain whether the document  needs to be dropped or rewritten.
TGA left the talks with industry with a list of ways in which the document can be improved, leading it to set out to remake the document. To work toward that goal, TGA has released a consultation paper that details the changes it plans to make to TGO 78 and outlines its reasons for the revisions. Many of the changes can be broadly categorized as attempts to reduce the burdens on manufacturers.
That objective underpins TGA’s rationale for broadening the range of standards manufacturers can follow. Currently, TGO 78 advises manufacturers to meet the requirements of a relevant individual monograph in the British Pharmacopoeia (BP) whenever possible. In the absence of a BP monograph, requirements specific to Australia apply.
This approach can pose problems for companies that manufacture and supply drugs internationally and therefore follow either the European or US Pharmacopoeias (EP or USP). To reduce the burden on such companies, TGA is planning to allow manufacturers to choose whether to comply with BP, EP, USP or Australian standards.
TGA is also proposing to add pills to the list of dosage forms covered by the document. Pills differ from tablets in that they are manufactured using wet massing, piping and molding techniques, not compression. The decline in the use of pills led TGA to drop its requirements on the dosage form in 2010. However, TGA now wants to reintroduce rules on pills that align with the Pharmacopoeia of the People's Republic of China. TGA plans to introduce the requirements on pills in 2020. 
TGA Consultation
CDSCO Demands Data on Fixed-Dose Combinations as Saga Continues
India’s Central Drugs Standard Control Organization (CDSCO) has told the manufacturers of tens of fixed-dose combinations (FDCs) to provide additional data. The requests are the latest twist in the multi-year row over whether hundreds of FDCs feature rational combinations of medicines.
CDSCO issued the latest demands in two notices to manufacturers of FDCs. The agency aimed one of the letters at the manufacturers of 49 FDCs that India’s Drugs Technical Advisory Board thinks may be rational but are supported by insufficient clinical safety and efficacy data. To remedy the data gap, CDSCO wants manufacturers to submit protocols for clinical trials designed to generate the required safety and efficacy results early next year.
The second notice went out to the manufacturers of 17 FDCs that have failed to provide enough data to demonstrate the safety, efficacy and rationality of their products. CDSCO has given the producers of these FDCs until the end of February to submit the requested data and information.
If the manufacturers targeted in either letter fail to submit the requested information, the authorities may make decisions about the future of their FDCs on the basis of the available materials.
CDSCO issued the notices alongside a letter aimed at companies that want to bring versions of FDCs deemed to be rational to market. The agency laid out a pathway for such subsequent, rational FDCs in notices last year, but has since reexamined the topic. The result is a new pathway that requires the manufacturer to seek a license from state authorities. Manufacturers do not need to obtain a no objection certificate from the Drug Controller General of India.
Protocol Request, Data Request, FDC Pathway
China Approves First Locally Developed Anti-PD-1 Checkpoint Inhibitor
China has approved the first locally developed anti-PD-1 checkpoint inhibitor. The approval marks a milestone for Chinese drug development and the start of the intensification of competition in the key oncology market.
Anti-PD-1/L1 antibodies came to market in the West around four years ago, but took much longer to arrive in China. Bristol-Myers Squibb and Merck received approval for their market-leading antibodies Opdivo and Keytruda in June and July, respectively, but the size of the PD-1/L1 drug pipeline in China meant the Western companies were unlikely to have the market to themselves for long.
Now, China’s National Medical Products Authority (NMPA) has approved what could prove to be the first of many locally developed anti-PD-1/L1 antibodies. Junshi Biosciences won approval to use its checkpoint inhibitor as a second-line treatment in patients with advanced melanoma, the same indication as covered by Merck’s Keytruda clearance.
While Junshi won the race to bring a locally developed checkpoint inhibitor to market, it is unlikely to retain its status as the sole Chinese company in the field for long. Innovent Biologics has already filed for approval of its candidate, the Eli Lilly-partnered IBI308, and tens of other companies including Beigene and CStone Pharmaceuticals have assets in development.
NMPA released news of Junshi’s approval on the same day as it revealed it has cleared Roche’s breast cancer drug Perjeta for sale in China. Perjeta is designed for use in combination with Herceptin in patients with HER2-positive breast cancer.
NMPA Notice, More (both Chinese)


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