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Asia Pacific

Set Alert for Asia Pacific

Pharma Will Need To Embrace More Inward-Looking China

The world’s second-largest economy is fast moving away from reforms and open to a "dual circulation" model, focusing on domestic market consumption while reducing export-driven production. Executives and investors shared views at a conference on whether multinational pharma firms are still welcome in China and what opportunities may lie in the drastic policy shift.

China Market Access

Voluntary Limits On Antibacterial Discharges Increase As Fear Of Resistance Grows

Pharmaceutical companies are ratcheting up voluntary efforts to control discharges of antimicrobials from their plants and those of their active pharmaceutical ingredient suppliers so they won’t contribute to antimicrobial resistance. But will it be enough to fend off regulation in countries like India?

Manufacturing Compliance

First Trials Report Reveals Uneven State of China Drug Development

Growing over 9% and domestic study sponsors take over 70% of the drugs in different stages, China clinical study sector attracts renewed interests post COVID, but underneath an uneven and less efficient field, noted a just released regulatory report.

Clinical Trials Research & Development

Coronavirus Notebook: UK Reports Impressive Booster Results, Drones Deliver Vaccines In Africa

Emergex is preparing to begin a Phase I study of its T-cell priming vaccine, RedHill BioPharma has completed enrolment in a Phase II/III study of upamostat, and Australia is assessing Moderna’s Spikevax for use in 6-11 year olds.

United Kingdom Australia

Tougher China Data Protection Laws Put Health Players On Alert

First LinkedIn, now Yahoo, the exodus of global tech giants from China indicates a toughening regulatory environment over personal data collection, storage and use with implications for pharma. Buckle up for a bumpy ride, experts say.

China Regulation

Global Pharma Guidance Tracker – October 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

India Proposes Faster Approvals, Bayh-Dole-Like Policy To Spur Innovation

India’s draft policy to catalyze R&D and innovation seeks to create a “regulatory bias” towards innovation and aims to cut approval timelines sharply, among a raft of other proposals that include enabling differential pricing for “innovation with therapeutic benefits.” The Pink Sheet explores multiple nuances of the plan with industry experts.

Policy India

Australian Industry Hails ‘Landmark’ Shortages Legislation

Legislation introduced in Australia aimed at mitigating shortages, that enshrines in law provisions of new five-year pharmaceutical industry pacts agreed by the government, has been hailed as a “landmark” development by the GBMA.

Australia Regulation

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
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