Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

China FDA Lays Out eCTDs, Bioequivalence, Patent Linkage As Priorities

Executive Summary

Surprise announcement by China FDA to roll out an electronic common technical document system by year-end is causing jitters in the pharma industry, but other moves to raise product quality and strengthen patent linkage seem more positive for manufacturers.

You may also be interested in...



China FDA Proposes Sweeping Reforms To Incentivize Innovation

The China FDA releases a raft of new regulatory proposals outlining fundamental changes in areas including patent linkage and data exclusivity, which look set to profoundly impact decision makers looking at bringing new drugs and devices to the world’s second-largest pharma market.

Spring Coming? EU Group Holds China To Fair Play Promises In Procurement

A major European business group in China is encouraged by recent signals of further policy reforms, but says in a new report it would like to see further progress on drug and device tenders, the lifting of indirect competition restrictions, and full implementation of the central push for a level playing field for foreign firms.

Sweeping China Policy Reforms Seen Bolstering Domestic Generics

Off-patent original drugs in China are set to face unprecedented competition as the country drives up policy support for high-quality, bioequivalent domestic generics, and outlines other sweeping moves covering pricing and compulsory licenses.

Related Content

Topics

UsernamePublicRestriction

Register

PS120150

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel