Pharmaceutical Regulatory Affairs in China

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong Macau and Taiwan.

Course Overview

This seminar will provide a detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong Macau and Taiwan and will cover all important aspects of gaining and maintaining a successful Marketing Authorisation in the region, CMC regulatory requirements, interpretation of practical aspects and an overview of the requirements for local manufacturing.

This seminar will provide a detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan and will cover:

  • All important aspects of gaining and maintaining a successful Marketing Authorisation in the region
  • Recent regulatory reforms
  • Drug regulatory systems
  • An overview of import and local manufacture registration
  • Clinical product development including CMC regulatory requirements
  • An interpretation of practical aspects
  • The opportunity to exchange experiences with other delegates

Who should attend

This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance in this region. You will find this seminar useful both as an introductory and or a refresher course.

Previous delegates have included:

Scientists and Technical staff in:

  • Regulatory Affairs
  • Registration Departments
  • Medical Directors

Personnel from the following areas:

  • Analytical Research and Development
  • Clinical Development
  • Quality Assurance
  • New Business Development
  • Regulatory Authorities

Programme

Day One

General introduction to the Peoples Republic of China and the pharmaceutical market

  • Commercial and cultural background

Drug regulatory systems

  • Regulatory authorities
  • Recent regulatory changes
  • Regulations and guidelines
  • Drug classification systems
  • Import and local manufacture registration
  • Data requirements
  • Registration requirements
  • Labelling requirements

Clinical product development

  • Regulatory aspects of clinical development
  • Recent regulatory changes
  • Documentation needs including CMC
  • Regulatory requirements including GCP aspects
  • Chinese specific approaches
  • Multinational clinical trials

Hong Kong SAR

  • Background overview
  • Regulatory authorities
  • Regulatory requirements and procedures
  • Specific market aspects

Macau SAR

  • Brief overview of regulatory aspects

Discussion session

Day two

P.R. China

  • Product registration strategies
    - Summary information contrasting import and local manufacture registrations
    - Planning to meet documentation requirements
    - Expediting regulatory approvals
  • CMC specific matters
    - CMC regulatory requirements
    - Current standards and future trends
  • Variations and renewals
    - Regulatory procedures
  • Documentation expectations

Taiwan (Republic of China)

  • Cultural background
  • Regulatory authorities
  • Regulations and guidelines
  • Drug classification systems
  • Data requirements
  • Country specific matters

P.R. China

  • Health authority interactions
  • Impact of recent regulatory developments

Final discussion

  • Summary and conclusions of the seminar

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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Previous customers include...

  • Abbott Laboratories Ltd
  • AbbVie AG
  • Baxalta Innovations GmbH
  • Bayer Consumer Care AG
  • Biogen Ltd
  • Bristol-Myers Squibb SA
  • Engelhard Arzneimittel GmbH & Co. KG
  • F. Hoffmann-La Roche Ltd
  • Ferring Pharmaceuticals Inc
  • Fresenius Medical Care Deutschland GmbH
  • Gilead Sciences International Ltd
  • Gilead Sciences Limited
  • Guerbet
  • HRA PHARMA
  • Menarini Ricerche
  • Merck KGaA
  • Mexichem UK Ltd
  • Nemera La Verpillière
  • Nestlé Skin Health
  • Novo Nordisk
  • ObsEva
  • Orion Corporation Orion Pharma
  • Pharma Quality Europe srl
  • Polpharma SA
  • PROMED CS Praha a.s.
  • Sanofi R&D
  • Stragen Pharma SA
  • Thomson Reuters
  • Valeant Pharma Switzerland GmbH
  • Zambon SpA

This course was well paced and met my needs in terms of content and interactivity. Both speakers were extremely knowledgeable and approachable which is I believe is important in this setting.

Chris Dodd, Medical Regulatory Manager, Mexichem UK Ltd

Great

Mia Kiistala, Senior Manager, Biogen

Good - quite interactive, easy to raise questions and get answers.

Hélène Bonnans, Regulatory/Quality Manager, Sanofi Chimie

Dynamic, knowledgeable, interesting presentations

Felicity Lyon-Staniewski, Associate Director, Biogen Ltd

The speakers were very nice, easy to understand and available

Antoine Halais, Regulatory Expert, Nemera