Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Australia Becomes First Country To Regulate Psilocybin & MDMA As Medicines

The Therapeutic Goods Administration said its decision to down-schedule two psychedelic substances to controlled drug status followed extensive public consultation, a report from an independent expert panel, and advice from the Advisory Committee on Medicines Scheduling.

Australia Regulation

China Planning To Ban Gene Editing Technology Exports

Beijing’s latest proposal to ban gene editing is viewed as a direct response to Washington’s tightening grip over the transfer of US technology to China.

China Gene Therapy

Chinese Balloon Affair To Blow Up US Health Collaboration?

The latest surveillance balloon downing could torpedo improving bilateral health collaboration between China and the US at a time when warming ties are crucial to solving a flurry of gridlocks.

China United States

Japan Changes Rules On Drug Names, Study Codes In Sponsors' Trial Sites

Japanese health ministry makes changes around the allowance of drug generic names and study codes in information provided by pharma companies on their websites for clinical studies, with the aims of improving transparency and facilitating patient participation.

Japan Clinical Trials

China Approves Two More Home-Grown COVID-19 Antivirals

Top-line results for two newly approved COVID-19 antivirals in China showed roughly 1.5- to two-day cuts in median time to symptom resolution or recovery in mild-to-moderate Omicron patients versus placebo.

China Approvals

Korean Industry Demands Bold Support Amid US Policy Moves

As the global biopharma industry attempts to understand the implications of the US Inflation Reduction Act, South Korea's biopharma industry is pressing its government to come up with "bold and rapid" additional measures to reduce the possible negative impact of the legislation and other US policies with international implications, and to support the sector amid generally rising global competition.

South Korea Policy

Australian Committee Wants HTA Review To Begin Early In 2023

At its next meeting, the Australian committee responsible for reviewing the country's health technology assessment system will discuss feedback from stakeholders, including the pharmaceutical industry, on the draft terms of reference for the review.

Australia Health Technology Assessment

China's Shrinking Population Poses New Challenge For Pharma

For the first time in 61 years, China has reported its population is shrinking and the new demographic shift is likely to have a far-reaching impact on the pharma sector. Meanwhile, regulators have accelerated the approval of new COVID-19 drugs to relieve acute shortages.

China Approvals

Feedback Sought On Proposed Regulatory Overhaul In New Zealand

A bill that seeks to introduce a new regulator and replace the over 40-year-old medicines legislation is now out for public consultation.

New Zealand Regulation

Jan Deadline For API QR Codes In India Arrives; Are Local, Chinese Firms Prepared?

Beginning January, packaging on active pharmaceutical ingredients (APIs) made in or imported into India is to bear a QR code, but the Indian industry is unprepared and feels the move isn’t beneficial. With about 70% of the country’s API imports coming from China, questions remain on its implementation too

Regulation Policy

Japan 2022 Review/Outlook: Supply Crisis, Incentives, Cost Controls In Focus

As Japan's pharma market continues to face supply chain challenges and rising healthcare costs, regulatory authorities are looking to policies that balance incentives in critical areas and temporary price rises with other other ongoing measures to contain the national drugs bill. The Pink Sheet takes a look at the key changes last year and what to expect in 2023.

Japan Policy

Global Pharma Guidance Tracker – December 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
See All
UsernamePublicRestriction

Register