Asia Pacific

Japan has announced several new measures to tackle the lack of rare disease and other therapeutics in the domestic market, with the country's main industry association also issuing the first common national informed consent form in a bid to lighten the “huge workload” on trial site staff.

The latest FDA guidance will have profound impact to Chinese biotech sector at a time when going global and a US approval is vital to its very survival.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Two announcements by the Pharmacy and Poisons Board have implications for drug companies looking to register their products in Hong Kong.

Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.

Two targeted treatments for six different types of cancer and two antifungal drugs are the first products that Pharmac has proposed should be funded after it received a boost to its budget in June. Separately, the government is seeking feedback on a bill to repeal the sweeping new therapeutic products law that was passed by its predecessor.

China’s National Healthcare Security Administration (NHSA) seems determined to require pharma firms to comply with the agency’s request to cap the prices of innovative drugs, according to a senior official directly involved in annual price negotiations.

If finally fully approved in its first indication, the HGF gene therapy could become a first-in-class therapy for PAD - but only after years of challenges in clinical trials.

With the sheen of inevitability now scuffed off the BIOSECURE Act, diplomatic efforts to reduce US dependence on Chinese APIs are increasing in prominence. And the power of the legislation itself could be determined by litigation about a video app.

India’s drugs regulator sets out plans for extensive digitization across the regulatory value chain and regulatory rationalization initiatives, while also “looking inward” to up its game as it tightens processes and enforcement. Audit action under the revised GMP norms is also being kicked off.

The off-label “cosmetic” use of GLP-1 receptor agonists such as Ozempic and Wegovy is contributing to global shortages of these drugs, prompting the European Medicines Agency to ask member states and manufacturers to “control and optimize” their use.

Not enough companies are complying with Pakistan’s pharmacovigilance rules, according to the drug regulator, which wants to remedy the situation after a previous attempt to do so failed.

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

Long-running protests by South Korean doctors against government reforms, including raising medical school admissions, continue to intensify with a one-day rally by community doctors and the threat of an indefinite walkout later this month. The pharma industry is also feeling the impact on clinical trials and sales. 

Antibody-drug conjugates, GLP-1 receptor agonists and cell/gene therapies propelled a big increase in clinical trial registrations in China last year, but why do sponsors sometimes remain reluctant to actually start studies?

A targeted review of the rules on labeling for injectable medicines is being carried out in advance of a wider updating of labeling requirements that took effect in 2020.