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Asia Pacific

Set Alert for Asia Pacific

Global Pharma Guidance Tracker – July 2022

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.

Guidance Documents Regulation

China Cool On Nasal Vaccines, Backs Antivirals In Latest COVID Guidance

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.

China Coronavirus COVID-19

APAC Regulatory Roundup: Infectious Disease A Common Theme As COVID Lingers

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.

Asia Pacific Infectious Diseases

Korea’s Regulatory Innovation Steps Focus On Investment, New Technologies

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.

South Korea Vaccines

Didi, Data And New China Cross-Border Transfer Regulations

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.

China Cybersecurity

China Innovative Drug Reimbursement Needs Major Revamp: Industry Group

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.

China Policy

China Clears HIV Oral Antiviral For COVID, Vows More Drug Approvals

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.

China Approvals

Korea Reimburses Zolgensma Amid Wider Cost Management Initiatives

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.

South Korea Reimbursement

China Compliance Risks In Focus As Digital Tools Spread

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.

China Compliance

Policies That Could Lead To Korean Biopharma Growth And Competitiveness

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.

South Korea Policy

BeiGene/Novartis's Tislelizumab Faces US Delay Over China Inspection Challenges

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.

FDA ImmunoOncology

Preparing for COVID 2.0: Understanding Animal ‘Spillover’ And Addressing Excessive Nationalism

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.

Coronavirus COVID-19 Research & Development
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