Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Asia Pacific

Set Alert for Asia Pacific

Coronavirus Notebook: EU & Australia Assessing Comirnaty In 5-11 Year Olds, Aviptadil shows Promise In Critical COVID-19 Patients

The European Medicines Agency has OKd new manufacturing sites and a ready-to-use formulation for Comirnaty, while Australia has provisionally approved Ronapreve for treatment and post-exposure prophylaxis. The UK has secured supplies of two investigational antiviral products from Pfizer and MSD.

Europe Australia

Pediatric Promise: China Bets On Better Medicines Amid Three Child Policy Roll-Out

As China's regulators renew moves to encourage the development of pediatric medicines, indication expansion may give health players a new growth engine, despite remaining policy challenges and lingering market uncertainties.

China Pediatrics

Global Pharma Guidance Tracker – September 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

Pharma Intelligence Launches Japan Awards

The inaugural Informa Pharma Intelligence Awards Japan will be held in Tokyo on 12 May 2022 to recognize and reward the very best innovations and achievements in pharma and biotech, highlighting Japan’s integral role in the global healthcare market.

Japan Regulation

Australia's Competition Regulator Authorizes Another Year Of Close Collaboration

Australian off-patent industry association GBMA and brand body Medicines Australia can continue to collaborate closely as part of work to mitigate shortages in the context of the COVID-19 pandemic, the Australian Competition and Consumer Commission has decided, extending an existing authorization by a further year.

Australia Regulation

China’s Top Regulator Upholds Tough Stance Against 'Redundant' Clinical Trials

China's Center for Drug Evaluation has issued fresh warnings that it will tighten reviews of anti-tumor drugs on the grounds that “redundant” development activities waste clinical resources.

China Clinical Trials

Korea Should Pursue Two-Pronged Strategy In Global Vaccine Hub Bid

South Korea is making a strategic push to strengthen its vaccine capabilities, with a focus on COVID-19 and future pandemics and the aim of becoming a global development hub. But one expert told a recent meeting that these goals should not overshadow the government’s original aim of becoming self-sufficient for the national immunization program.

South Korea Vaccines

Stringent Regulations Hinder International Trials In China: Trade Groups

Any delays caused by unpredictable regulatory reviews related to the export of genetic materials threaten to derail the inclusion of China in international clinical trials, caution two trade groups representing the pharma industry in the country.

China Clinical Trials

Ready, Set, Go: China To Use Patient-Reported Outcomes In Clinical Studies

As a part of real-world evidence, patient-reported outcomes can serve to evaluate a drug's efficacy against primary or secondary endpoints and also reflect safety and quality of life, notes a just-released draft regulation from China’s Center for Drug Evaluation.

China Real-World Evidence

GMP Deficiencies Lead Brazil To Target Sinovac’s Chinese COVID-19 Vaccine Plant

Having decided to suspend 12 million doses of Sinovac’s coronavirus vaccine, Brazil’s regulatory agency says it will need to make its own on-site assessment of conditions at the Chinese facility that makes the product.

China Brazil

Project Orbis Nears 30 Approvals In Oncology; Could China Be Added?

A review of drugs and supplemental uses since the project’s inception shows roughly one-third of the products reviewed have been NMEs.

Review Pathway Cancer

Australian Industry Signs Deal To Fund Access To Innovative New Drugs

Hot on the heels of Australia’s plan to overhaul the National Medicines Policy comes a new deal with the pharmaceutical industry to make new drugs available as soon as possible after approval and get patients more closely involved in reimbursement processes.

Australia Market Access
See All
UsernamePublicRestriction

Register