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Asia Pacific

Set Alert for Asia Pacific

Gene Therapy HTA: How Do The European, Australian And Canadian Systems Shape Up?

A report comparing the health technology assessment methods used in nine European countries, Australia and Canada found that England has the most favorable reimbursement landscape for gene therapies – but outlined several areas for improvement across the board.

Europe International

Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms, Talent

South Korea has formulated new detailed policy measures to support the formation of major bioclusters, which will offer tax and other incentives in a bid to lure foreign firms and talent.

South Korea Biologics

China’s Regulator Has New Head But Will He Advance Further Reforms?

A new commissioner has taken the reins at China's National Medical Products Administration, but the senior CCP official has so far given few clear indications about the changes he might bring.

China Leadership

Japan Takes New Steps To Build On Real-World Data Foundations

As Japan widens its window for the use of real-world data to support drug development though revision of the Next Generation Medical Infrastructure Act, the pharma industry is hoping for more regular inclusion in regulatory filings. A dedicated group within the PMDA shares its views on how the area is developing and practical measures being taken to drive RWD adoption.

Japan Regulation

Global Pharma Guidance Tracker – August 2023

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

How Useful Are Surrogate Endpoints In Securing Reimbursement Of Cancer Drugs?

A group of Australian researchers says that the use of surrogate outcomes needs to be better justified if health technology assessment bodies are to make more consistent funding decisions for cancer medicines.

Australia Health Technology Assessment

Publisher's Spotlight: Shortlist Unveiled For Citeline Japan Awards

Following consideration by our independent expert judging panel, the final shortlist of entries has now been revealed for the Citeline Pharma Intelligence Awards Japan 2023. Join us at the event in Tokyo on 17 October!

Japan Commercial

Hong Kong Industry Calls For Formation Of Local FDA In Biotech Drive

Local industry insiders argue that a full-fledged drug regulator would boost the chances of making Hong Kong an international innovation and biotechnology center, by elevating the city's role from a transit corridor to a platform for biomedicine review and approval.

China Hong Kong

New Law Aims To Promote, Shape Regulatory Science In Korea

Along with the passage of new regulatory science innovation legislation, South Korea is pursuing a broad range of initiatives to improve and shape its activities in the field to better keep abreast of rapidly advancing biopharma technologies.

South Korea Regulation

Quotable: Top Experts On Policy Hot Topics

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

International Europe

Chinese Regulator Pushes Limits Of Tightening Conditional Approval Program

A new potential policy shift in China seeks to address abuse of a regulatory shortcut by blocking fast-followers’ applications for related clinical trials.

China Approvals

How To Use The UK’s New International Recognition Pathway For Drug Approvals

Eligibility criteria, how to apply, 60-day and 110-day timetables, major objections and clock stops. These are among the topics that the Medicines and Healthcare products Regulatory Agency covers in newly published guidance for drug companies planning to use the soon to be launched IRP.

United Kingdom International

Video Roundtable: APAC Team Talks Key Regional Trends And Topics

Join the Pink Sheet's APAC content team for a video overview of major trends and topics in the regional biopharma industry over the past few months.

Asia Pacific Commercial

Japan Sets Luxturna, Other New Prices While Cutting Selected Fast Growers

Six new drugs including Luxturna will be price-listed in Japan on 30 August, with the Novartis gene therapy set to become the second-most expensive therapeutic product in the country. Behind another round of market expansion-related price cuts for selected drugs, discussions on possible changes to the repricing system are ongoing.

Japan Regenerative Medicine

Pakistan Sets Deadline For Companies To Submit Pharmacovigilance Officer Notifications

Pakistan’s medicines regulator is disappointed that so few drug companies have complied with a requirement notify to the National Pharmacovigilance Centre about their designated pharmacovigilance officers. 

Pakistan Drug Safety

India’s Generics-Only Rx Rule: Not What The Doctor Ordered Or What Pharma Wants?

New norms call for generics-only prescriptions and prohibits doctors from engaging in third-party educational activity backed by pharma in India. Will pharma need to rethink its branded generics strategy in India or will questions about quality assurance sink the rules?

Regulation India
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