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Asia Pacific

Set Alert for Asia Pacific

As US, China Intensify Cybersecurity Crackdown, Companies Urged To Be Conservative

The latest developments around data security and protection signal the need for rigorous implementation of procedures and potential significant cost increases for pharma and other companies operating in China.

Cybersecurity Policy & Regulation

The Indemnity Calculus For Covid-19 Vaccines, India’s Path Ahead

Legal experts discuss the intricacies around pharma’s demand for indemnity, a key sticking point for supplies of COVID-19 vaccines from Pfizer and Moderna, and the path forward for countries like India.

Commercial Coronavirus COVID-19

China Signals Further Clinical Trial Policy Tightening

The nation’s top drug regulator vows to adopt ICH’s guidelines on drug safety and efficacy, after dropping the industry a bombshell with the tightening of oncology drug clinical trials a week ago.

China Clinical Trials

Global Pharma Guidance Tracker – June 2021

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

Anti-Tumor Drugs Under Closer Scrutiny As China Confronts Widespread Misuse

China has introduced new rules relating to the designation and control of cancer drugs, which are being seen by some specialists as not ideal from a clinical practice perspective but positive for novel drug development.

China Market Access

China Cybersecurity Reviews Signal New Regulatory Tightening Wave

Increasing cybersecurity reviews and the incoming Data Security Law are expected to affect companies collecting, processing and transferring data in China, and the impact is likely to go beyond its borders in relation to privacy protection and national security implications. But the health sector may be less affected than consumer services. 

China Cybersecurity

Lupin’s Corporate Quality Oversight Questioned In FDA Warning Letter

Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.

Manufacturing Quality

FDA’s Pazdur Blames Trial Design Errors For Some PD-1/L1 Failures, Foreshadows Potential Agency Leniency

US FDA Oncology Center of Excellence Director Rick Pazdur says PD-1/L1 drugs are very similar and hypothesizes that when competitors show differing results in the same indication it's more about trial design than the drug. FDA oncology experts also weighed in on regulatory clearance of Chinese-developed checkpoint inhibitors and trial endpoints that have come under outside scrutiny.

ASCO ImmunoOncology

Study Flaws, Data Integrity Issues Clog China Review System As Applications Soar

Facing a 40% increase in investigational new drug applications, regulatory reviewers in China are scrambling to turn down hundreds of filings plagued by major study design flaws, inconsistent samples and quality control failures.

Policy & Regulation Drug Approval Standards

Latest Japan Approvals Include Evrysdi For SMA

Japan's latest batch of product approvals includes the country's second therapy for SMA and the first nod globally for a novel antidiabetic.

Japan Approvals

China’s First CAR-T Is From Fosun Kite; Overseas Data Played Key Role

Confounding earlier speculation, the Fosun-Kite joint venture rather than Juno-WuXi AppTec, gains the first CAR-T cell therapy approval in China. The clearance is expected to be followed by several others in the highly active area.

China Approvals

As Delta Plus Variant Identified, Changes To India’s Trials Policy Could Help

As a new Delta plus variant is identified, India’s exemption of bridging trials for imported COVID-19 vaccines could help speed up immunization efforts. The urgency to fully immunize individuals could also prompt a reduction in the interval between Serum/AstraZeneca’s COVID-19 vaccine doses

Policy Coronavirus COVID-19
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