Recent Changes to Drug Approvals in China: Regulatory Consultation, IND Submission and Acceptance of Foreign Data in NDA

Clinical Trials, Emerging Market, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • Monday, December 03, 2018

Historically, the review and approval of a Chinese investigational new drug (IND) has taken a year or even longer to complete, and new drug application (NDA) approval for a new drug lagged behind Western countries by four or five years. Recently, the National Medical Products Administration announced changes to encourage pre-IND consultation and shortened the clinical trial approval process to 60 working days, opening up new opportunities to expedite development. Changes were also made to encourage NDA submissions that are aligned with submissions in other regions.

Join this webinar to learn how to plan your first IND application in China. The presenter will:

  • Help you understand the new 60-day review system
  • Explain new ways to consult with Chinese regulatory authorities

Additionally, this talk will also:

  • Cover China’s current thinking about accepting foreign data for the approval of new drugs
  • Explain how to apply ICH E5 and ICH E17 to facilitate simultaneous registration of medicinal products in different geographic regions

 

Speaker

Peiling Shih, Executive Director of Regulatory Strategic Development, APAC, Clinipace

Peiling Shih brings more than 20 years of experience in regulatory affairs to her role at Clinipace as executive director of regulatory strategic development for the Asia-Pacific region. Her expertise in regulatory strategy development accelerates marketing approval and resolves regulatory review issues for customers across China, Korea, Taiwan and throughout the Association of Southeast Asian Nations region.

Prior to Clinipace, Shih gained experience in regulatory affairs from early-phase new drug development to new drug registration, post-marketing extension and life-cycle management at MSD, GE Healthcare and Abbott.

Message Presenter

Who Should Attend?

Senior professionals from pharmaceutical, biotechnology, medical device & diagnostics companies involved in:

  • Operations
  • Regulatory affairs
  • Strategic development
  • Marketing and commercialization

What You Will Learn

  • China’s new 60-day review system
  • New ways to consult with Chinese regulatory authorities
  • China’s current thinking about accepting foreign data for the approval of new drugs
  • How to apply ICH E5 and ICH E17 to facilitate simultaneous registration of medicinal products in different geographic regions

 

 

Xtalks Partner

Clinipace

At Clinipace, a global, full-service contract research organization (CRO), our approach to clinical research is personal. We deliver a level of collaboration and flexibility not possible in a traditional CRO environment. Our personalized services and solutions, local regulatory expertise and therapeutic leadership are designed to face the most difficult industry challenges across all major therapeutic areas including oncology, gastroenterology, nephrology and urology. We strive to improve the way clinical research is performed and impact the future of health care using the most advanced technology and a CHALLENGE ACCEPTED approach

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