Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Asia Pacific

Set Alert for Asia Pacific

Reimbursement, Vaccine Issues Dominate EU Group's Korea Concerns

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.

South Korea Europe

Dissecting Piramal’s Damages Award In Sensipar Case

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.

Legal Issues Generic Drugs

China Drug Price Negotiations: Another Race To The Bottom?

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?

China Reimbursement

Pre-work Rigour, 'Clean' Documentation Key As FDA Unlocks Remote Inspection Tools

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.

Manufacturing Compliance

Big In Japan: Assessing Seven Years Of Sakigake

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.

Japan Review Pathway

Cell, Gene Therapy A No Entry Zone? EU Group Seeks Clarification Over China Regs

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.

China Regulation

'Incorrect' To Assume Interchangeables Are Safer, More Effective Than Biosimilars, Says FDA

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.

Biosimilars Drug Safety

COVID-19, Oncology Dominate Korea’s Fast-Track Approval Program

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.

South Korea Approvals

Pharma Readies For Price Caps On Glargine, Teneligliptin, Lenalidomide In India

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.

Policy India

EU, US & Japan Welcome India In ‘Critical’ Pharmacopeial Harmonization Move

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.

India Quality

What Is Slowing Industrialization Of Korean Digital Healthcare?

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.

South Korea Digital Health

Global Pharma Guidance Tracker – August 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.

Guidance Documents Regulation
See All
UsernamePublicRestriction

Register