Asia Pacific

Japan will end full reimbursement coverage for COVID-19 therapeutic drugs from October, after downgrading the status of the virus to the same level as seasonal flu in early May. As authorities discuss the possible coverage reduction, a larger than usual price cut may also be applied to Shionogi's oral COVID antiviral Xocova.

FDA Commissioner Robert Califf spoke of the need for a better hand-off to CMS, including tailoring trials to generate evidence relevant for Medicare coverage. He also weighed in on the possibility of accelerated approval for chronic disease drugs, among other topics.

Japanese regulatory authorities have announced a set of additional reimbursement price cuts for selected products in August, under which Novartis’s heart failure drug Entresto will see its price slashed by 15%. A batch of other newly approved drugs has also been priced.

China has taken a new counterstrike against the US in the chips sector, but the risk of potential wider impact on the biopharma sector appears to be limited given other tighter regulations already in place.

Drug sponsors have been told to continue applying for extensions to good manufacturing practice clearances for overseas manufacturing sites as long as they meet the criteria for extension and apply in good time.

Leaders from Novartis, IQVIA and PwC discuss the ground situation for trials in India as regulatory reforms, improved infrastructure and clinical expertise provide opportunities. Potential in areas like orphan diseases and tips for peer Amgen on getting trials going in India were among other highlights.

Japan has approved abortion drug mifepristone but will limit its use to clinics with authorized physicians, with strict nationwide monitoring of sales. The majority of more than 10,000 public comments around the approval were in support of the new option for women. 

The recent arrest of a local Japanese employee of Astellas triggered alarms for pharma firms operating in China, while a newly-expanded and wide-ranging anti-espionage law means that sponsors must pay careful attention to overseas data transfers, especially related to clinical trials, business intelligence and due diligence, as well as other activities.

Pakistan’s medicines regulator is inviting stakeholder feedback on its approach to presenting information in patient information leaflets to support the safe and effective use of medicines.

A second court in India establishes an intellectual property division to consider IPR matters and notifies rules following the dissolution of the Intellectual Property Appellate Board in 2021. Legal experts outline what that may mean for the efficiency and quality of IPR adjudications.

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.

The Pink Sheet takes an infographic look at South Korea's clinical trial trends in 2022 to illustrate how the country's biopharma R&D is developing and how activities are recovering in the post-pandemic situation. One key takeaway is that approvals for trial starts have fallen back to pre-COVID levels, suggesting a falling off of activity related to drugs and vaccines for the virus.