Asia Pacific

Experts discussed regulatory science issues at a recent forum in South Korea, including the responsibilities of sponsors and regulators as well as the need to strengthen collaborations and accelerate the development of innovative drugs and converged medical products.

An updated guide from the Therapeutic Goods Administration proposes that sponsors of marketing applications for drugs that require companion diagnostics should provide reassurance that Australian patients will have access to at least one IVD that is adequate for companion testing.

Notable new drug approvals in South Korea last year included Pfizer’s Tukysa, Genentech’s Columvi and BeiGene’s Tevimbra, but the tally did not include any domestically-originated products. Alzheimer’s disease therapy lecanemab may be on the horizon this year.

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.

Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.

China’s public payer perceives innovative drugs in a different way from that of the country’s top drug regulator, a former senior healthcare security official with knowledge of the matter reveals. The posture has unnerved pharma companies, which have been hit by sharp price discounts.

The potential impact of the BIOSECURE Act continues to spread as the Biden administration increases its focus on China. But with BIO's top lobbyist and the top House sponsor of the legislation now headed out the door, the future of the bill remains uncertain.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed, an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees, and Japan’s PMDA opening an office in Washington D.C.

A newly enacted regulation in China governing the overseas transfer of data allows waivers under certain conditions but also introduces some new hurdles compared to the draft version.

Through a new full-time office in the US capital, Japan's drug regulator aims to provide essential regulatory information to help US bioventures enter the Japanese market at an early stage.

A revised pharmacovigilance guideline will come into effect in New Zealand on 1 July, although sponsors may start using it now.

The Therapeutic Goods Administration says it has made a series of improvements in areas such as the recall and stakeholder communication process, reporting requirements, and the agency’s guidance materials.

India’s revised code for marketing practices includes US Sunshine Act-like requirements converging with tax laws and puts the spotlight on continuing medical education initiatives, where pharma will need to display funding/expenditure data on their website. The Pink Sheet talks to experts on the implications and also new requirements on brand reminders and drug samples.

Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.

Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India’s evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad.