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
UsernamePublicRestriction

Revised China Drug Regulation Sets Back IPR Protection – Experts

Executive Summary

Long-awaited revised draft of China’s main drug registration regulation has legal experts wondering whether the China FDA is opening the flood gates to generic copies of new drugs due to a loosening of patent linkage provisions. Lack of provisions on review time limits and multiregional trials also disappoint some, although new OTC moves may be positive.

You may also be interested in...



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

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.

2016 Review: Rapid Change Defines China Regulatory Environment

If you missed some of the many significant events in China’s policy and regulatory landscape in 2016, here is your opportunity to catch up on month-by-month developments.

Asia Spotlight: New Strategies Needed As China Shakes Up Drug Classes?

In a fundamental shakeup of chemical drug classifications in China, foreign imported products are now in a class of their own while domestic drugs will be considered generics unless they are NCEs or have new formulations or indications. The changes are set to change the competitive landscape in profound ways, industry observers predict.

Topics

UsernamePublicRestriction

Register

PS118845

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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