Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Weighs Regulatory Options for Tackling Opioid Crisis
The Therapeutic Goods Administration (TGA) of Australia is seeking feedback on possible ways it can use its regulatory powers to address the opioid crisis. TGA has put forward eight ideas it thinks may contribute to a reduction in the excessive and inappropriate use of opioids in Australia.
Opioid use and deaths related to the painkillers in Australia have risen in recent years. The situation is better than in some countries — seven nations prescribe more daily doses of opioids per 1 million citizens than Australia — but the trends seen in the data have nonetheless caused alarm. Opioid deaths increased by about 60% in the decade leading up to 2015. That rise was underpinned by more accidental deaths relating to oxycodone, morphine and codeine.
TGA wants to use its powers to affect these numbers. Officials think they can pull multiple levers to either discourage the inappropriate use of opioids or encourage the adoption of analgesics that are associated with fewer complications.
The deterrents to misuse proposed by TGA include the registration of small packages of opioids for use in the treatment of acute pain. These packs would enable patients to access opioids but cut the risk they will continue using them for longer than a few days. Two- to four-week packs would remain on the market for the treatment of cancer patients. Alternatively, TGA may review the indications in which strong opioids are approved to control their use outside of cancer.
Other deterrents to misuse proposed by TGA include the removal of high-dose painkillers from the market, strengthening of risk-management plans, the review of label warnings and creation of new regulatory controls for strong opioids.
Officials are also considering changes that would diminish the need for opioids. Specifically, TGA is considering whether to create a priority review pathway for non-opioid painkillers. The problem is the pipeline of such products is weak. As such, while TGA is open to inducing development of these drugs and ensuring they get to patients as quickly as possible, factors beyond its control mean these efforts will take years to pay off, if they ever do.
TGA thinks all of the strategies may have some effect on the use of opioids, but has downplayed the extent to which it can address the crisis. The agency thinks that, while regulation has an important role, changes in prescriber behavior and patient expectations about opioid use in chronic conditions beyond cancer will make a bigger difference. That reflects TGA’s belief that the opioid crisis stems, in part, from the inappropriate use of the cancer analgesic ladder in other forms of chronic pain.
The next step is for people to give their views on the proposals. TGA is accepting feedback until 2 March.
TGA Revises Q&A to Explain new Product Information Format
TGA has published a question and answer document about its revised product information format. The lengthy text explains why TGA has reformatted the documents and how the changes will affect sponsors of existing products and those that are yet to come to market.
Australian officials switched over to the new product information format at the start of 2018. The new format brings the Australian product information format more in line with those used in Europe and New Zealand while also making critical clinical details more accessible. Certain categories of drug applications must already use the new format. All marketed products must adopt the format by the end of 2020.
The Q&A is designed to help sponsors comply with these requirements. TGA starts out by covering general topics, for example by confirming that the Australian product information can be used in the boxes of certain injectable products sold in New Zealand.
Most of the new and revised sections of the Q&A relate to technical matters. TGA has used the update to clarify that the fonts used in its template are indicative, not mandatory, and that not all headings and subheadings should be numbered. The agency has also confirmed that sponsors must include headings about use of their drugs in the elderly and children, and that developers of generics and biosimilars must adopt the new format.
CDSCO Targets Biosimilars in 2018 Clinical Trial Inspection Plan
The Central Drugs Standard Control Organization (CDSCO) has made biosimilar clinical trials a focal point of its 2018 inspection strategy. More than 40% of the biologics inspections penciled in for the year involve trials comparing biosimilars to reference products.
Over the course of 2018, CDSCO plans to inspect clinical trials involving copies of major drugs including Amgen’s Neulasta, Novo Nordisk’s NovoMix and Roche’s Neupogen. In total, CDSCO has lined up 27 inspections, 12 of which involve studies to compare the bioequivalence and other factors of innovator biologics and potential rivals.
The composition of the inspection plan reflects decisions by Indian drugmakers including Hetero, Intas Pharmaceutical and Virchow Biotech to invest in the development of biosimilars.
Officials at CDSCO’s headquarters drew up the list and shared it with their colleagues at the agency’s regional offices. CDSCO zonal offices will now confirm the status of the targeted clinical trial sites before planning visits. A team comprising inspectors trained in good clinical practices, a subject expert and a representative of CDSCO’s headquarters will conduct the visits.
CFDA Outlines Plans to Overhaul Pharmaceutical Standards
Chinese regulators have detailed plans to revise the country’s pharmaceutical standards system. The China Food and Drug Administration’s (CFDA) strategy builds on the new vision for drug regulation sketched out by the central government last year.
CFDA plans to have the new system operational by 2020. This will affect the thousands of pharmaceutical and medical device standards in place in China and, if all goes to plan, equip CFDA to cut the time it takes to revise rules and thereby continuously improve safety and quality.
The new focus on speed could have particular implications for the medical device industry. CFDA, following the central government’s lead, wants to make China more amenable to innovative medical device companies. Given the fast advance of robotics and other novel enabling technologies, this will entail ensuring standards do not impede the development of devices that break new ground.
China Seeks Feedback on Proposed Drug Approval Transparency Policy
CFDA has outlined its planned approach to the disclosure of information about the review and approval of drugs. The draft policy proposes sharing some basic and pooled, anonymized information about drug filings while protecting the confidentiality of more sensitive materials.
Chinese officials plan to disclose some details from the conclusions of their technical reviews of new drugs but keep personal matters and any information viewed as a state or commercial secret private.
Publication of the text focused on transparency in drug approvals comes two months after CFDA released a more general document on its approach to sharing information with the public. That text laid the groundwork for the current draft by putting improved explanations of CFDA decisions on the agency’s agenda.
CFDA is accepting feedback on the draft until 21 February.
has appointed 19 people to assistant drugs controller posts on an ad-hoc basis. CDSCO Notice