Asia Pacific

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.

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.

Japan issues approval recommendations in new indications, including Torii's Vtama in atopic dermatitis and AbbVie's Skyrizi in ulcerative colitis. Separately, filing requirements for the use of concomitant therapies have been revised.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Japan has been promoting a revised law that will allow the broader use of real world data by allowing the use of both pseudonymised and anonymised data.

US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

The 15 July entry deadline for the Citeline Japan Awards 2024 in Tokyo is fast approaching, so here's a reminder to take a look at the categories and criteria and be sure you get those submissions in by this date. Sponsorship opportunities and tables are also available. 

Next Generation Gene Therapeutics is fast-tracking clinical trials in the US for its gene therapy candidates for Bietti's crystalline dystrophy and classic phenylketonuria, supported by China data, the Chinese venture's CEO says in an interview.

Faster, more powerful and able to handle voices and visual images, newly released AI platform GPT-4o could potentially accelerate many tasks currently handled by pharma firms' medical affairs professionals, who are exploring ways to keep themselves relevant while embracing the unprecedented technology, DIA China hears.