Asia Pacific
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China Regulatory Express: Patent Linkage, Data Protection, Bio Five-Year Plan
Important changes are coming to China's Drug Administration Law as the government aims to address through several revisions a number of key issues since the law’s original enactment in 2019.
Japan Passes New Economic Security Bill – What's The Pharma Impact?
Japan has passed a new law which will require the providers of certain products to cooperate in securing supplies to the country. For the pharma industry, there are a couple of signs which specific drugs will be within the scope of the legislation and how this will impact the sector.
China Plans Law Revisions To Encourage Orphan, Pediatric Drug Development
New draft rules outline market exclusivity provisions for orphan and pediatric drug development, along with mutual recognition of ethics reviews, in developments being seen as positive for the industry.
As WHO Rings COVID Zero Alarm, Study Says China Vaccination 'Insufficient'
The WHO calls the "COVID Zero" containment policy that Beijing is doubling down on "unsustainable," while a new study has shed light on the potential cost of moving away from cutting transmissions to mitigating disease.
Going Global Gets Stuck, Chinese Drug Makers CRL Show What Not To Do
Chinese drug makers have more to lament and plenty to learn from as Junshi, HutchMed follow Innovent Bio with FDA rejections. A holistic not opportunistic approach is needed, one ex-FDA expert suggests.
Global Pharma Guidance Tracker – April 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.
Australian Regulator On The Highs & Lows Of Project Orbis
The US FDA-led initiative for collaborative submission and review of new cancer drugs has produced a number of benefits since it was introduced in 2019, including more “robust” regulatory decisions and earlier market access, the DIA Europe 2022 conference heard.
Beijing Expands COVID Testing; Stringent New COVID Policy Coming?
Beijing expands mass testing to more areas and Shanghai’s case fatally rate raises questions amid China deals with the worst outbreak in two years.
Korea Regulatory Support Group To Speed Drugs, Vaccines For Public Health Crises
The Korean drug ministry has formed a commercialization strategy support group to accelerate the development of drugs and vaccines for public health crises, along with new technologies or concepts, underscoring the significance of successful development of new home-grown options.
Lost In Translation? Japan’s GMP Compliance Dilemma
As Japan tightens regulations for good manufacturing practice, some members of the domestic pharma industry, including one inspector, are recognizing the need for official translations for foreign companies, which the ministry denied a year ago and continue to present challenges.
India-Japan Partnering Momentum: Regulatory Alignment Is Key
Biopharma executives from India and Japan discuss the need for enhanced “alignment” on the regulatory front, including exploring the possibility of a mutual recognition agreement as the two nations seek to expand biopharma partnering efforts and also build supply chain resilience.
Beijing Rules Against Chugai In China’s First Patent Linkage Suit
A new ruling in China indicates patent holders may have a harder time challenging generic manufacturers.
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