Scrip 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

Bayer Global Regulatory Affairs Head Joseph Scheeren On MRCT In China: An Interview With PharmAsia News

This article was originally published in PharmAsia News

Executive Summary

The possibility China may scale back the acceptance of Multi-Regional Clinical Trial (MRCT) data has become a hot topic between China FDA and industry. On the sidelines of a recent special Asia Pacific Economic Cooperation (APEC) meeting on regional clinical trials, Joseph Scheeren, head of global regulatory affairs for Bayer, shares his views.

You may also be interested in...



China And Taiwan Move Toward Clinical Data Mutual Acceptance, Regulatory Harmonization

China and Taiwan's top health regulators have signed an agreement to harmonize clinical and non-clinical studies toward mutual data acceptance. The deal could open doors for more Taiwanese drugs in the Chinese market, industry experts say

Japanese Regulators, With Drug Makers Support, Moves Toward East Asian Clinical Data Sharing And Acceptance

Japan is determined to further an initiative in promoting multi-regional clinical study data acceptance among East Asian countries, and the proposal has gained critical support from the nation's drug making industry

Journey East: How Chinese Returnees Build Global-Bound Biopharmas

As Chinese returnees transform their startups to fully-fledged biopharma operations with a full product lineup and the global market in sight, the journey has been filled with challenges. Based on interviews and on-the-ground reporting, this new series takes a closer look at several companies' experiences.

Topics

Related Companies

UsernamePublicRestriction

Register

OM006664

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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