Asia Pacific

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China’s Center for Drug and Evaluation has issued new guidance on the development of new vaccines and drugs for COVID-19 in which it backs antivirals as a key weapon, while the Politburo has shown no signs of backing away from the country's tough "COVID Zero" policies.

A roundup of key regulatory and policy developments in the Asia-Pacific in the first half of the year reveals broad developments across the region's diverse markets, although there seemed to be a common thread - a renewed focus on infectious diseases amid the lingering impact of the pandemic and the emergence of new threats.

South Korean ministries release comprehensive broad steps under new government aimed at accelerating investment to deal with infectious diseases and supporting regulatory innovation, including speeding up processes, to match global standards, support new technologies and improve access.

Beijing imposes $1.2bn in fines on China's largest ride-hailing operator Didi for personal data security violations, putting the spotlight once again on the need to pay close attention to the latest draft regulations in the area, which could have a profound impact on any foreign businesses - including pharma - operating in the world’s second-largest economy.

A domestic pharma industry group says China’s reimbursement scheme for innovative drugs needs rewriting to encourage innovation. At issue are a fixed reimbursement ratio maintained in the national public insurance program, the cycle of drug price negotiations, and exemptions from negotiations for expanded indications.

As the Communist Party of China gears up for its once in every five years National Congress late this fall, the need for more novel drugs to help address the persistent coronavirus pandemic is rising amid the country’s strict “COVID Zero” policies.

Zolgensma becomes the second Novartis gene therapy - and highest-priced therapeutic product - to be reimbursed in South Korea, prompting authorities to come up with plans to manage expensive therapies to ensure the sustainability of the national health insurance system.

In an era of increasing patient participation, digital health tools and ubiquitous social media use in China, several potential compliance risks should be on the radar while conducting clinical study, patient recruitment and commercial activities, caution legal experts in a new report.

A major South Korean pharma industry association provides multiple policy proposals to the country's new government, which it sees as supporting the sector’s growth and international competitiveness through improved regulatory science and other updated approaches.

An inability to conduct manufacturing field inspections in China due to strict local COVID-19 policies is cited as the only reason for the delay for the anti-PD-1 drug, for which the timescale for resolution is currently unclear.

Former Merck executive Julie Gerberding, Biocon chief Kiran Mazumdar-Shaw, ModeX Therapeutics’ John Mascola, and NIH’s Larry Tabak discuss what it will take to better handle the next pandemic.