Asia Pacific

Pharma-related regulatory issues are dominant in the latest annual White Paper from the EU Chamber of Commerce in Korea, accounting for 22 of the 96 concerns raised across 18 industries that will be shared with ministries. Quality of life issues around drugs for chronic disorders, risk-sharing agreements, reimbursement and vaccine policies are some of the key questions raised.

A legal expert details how Piramal Healthcare could turn the tables and secure damages in the litigation pertaining to its generic version of Amgen's Sensipar, a case which saw multiple at-risk launches.

With the fourth quarter just around the corner, China's closely-watched annual drug reimbursement and prices negotiations are entering a key final stage. But will applicants need to be more strategic than expedient?

A senior Parexel executive and ex-FDA pharmaceutical quality assessor emphasizes at a conclave why “first impressions matter now more than ever” as the agency  deploys complex alternate inspections tools which the pandemic provided, and that companies need to ensure that they get things right the first time.

Japan’s fast-track approval system for innovative drug candidates has marked its seventh year since launch, during which it has accepted 27 candidates with 13 of these moving to approval. But in recent years the system has faced a decreasing number of admitted candidates, this original infographic analysis shows.

China’s Negative List for Foreign Investment explicitly bars “investment and application in human stem cells, genetic diagnosis, and treatment technologies.” But whether that applies to foreign pharma firms developing such modalities in the country remains unclear.

US FDA India country director Dr Sarah McMullen provides a fact check at a recent conclave to dispel the notion that interchangeable biosimilars are safer and more effective than other approved biosimilars.

The number of approvals under a South Korean fast-track scheme launched around two years ago has increased, led more recently by COVID-19 vaccines and treatments, as well as anticancer drugs. Meanwhile, a new breakthrough therapy program similar to that in the US has been introduced to prioritize and speed up regulatory reviews of innovative medicines.

India’s national list of essential medicines 2022 features 34 additions, including insulin glargine, teneligliptin, lenalidomide, bedaquiline and montelukast, with price control expected to follow on these drugs.

The Indian Pharmacopoeia Commission was the only applicant that made the grade for entry in a pilot program that was launched to assess countries that want to join the EU, US and Japan as full members of the 33-year-old Pharmacopoeial Discussion Group.

At a recent policy forum in Korea to discuss regulatory improvements, participants talked about the factors keeping the digital healthcare industry from taking off, despite ongoing efforts.

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.