China: Compliance Processes for Life Science Products: Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
90 Minutes
Product Description

Get All the Regulatory Compliance Requirements and Procedures for Life Science Products in China

The Chinese government's establishment of a single drug regulatory authority in 2003 (China Food and Drug Administration) was an important step toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies, centralized the Chinese healthcare regulatory system, and made it more transparent to industry partners.

The CFDA now oversees all medications. Other former functions of the ministry have been assigned to different government bodies. The most important of these was the transfer of medical insurance responsibilities to the new Ministry of Labor and Social Security. The Ministry of Health retains its other main functions: regulatory development and oversight, healthcare resource allocation, and medical research and education.

In 2010, China amended GMP, GLP, GCP, GSP and other regulations with an aim to further align the country with international standards of practice. For manufacturers and distributors and importers of drugs and medical devices in China, it is imperative to pay close attention to the pace at which CFDA implements these changes. They have to make changes accordingly to their standard operating procedures, so that they can ensure compliance quickly and effectively with the evolving regime.

China [CFDA] continues to make Regulatory Requirement Changes at a fast pace. Just in the last couple of years alone, changes have been proposed and implemented in Drug & Biologics Licensing, Medical Device Registrations and have been proposed for Dietary Supplements approved by CFDA. This 90-minute webinar will update you with all of these changes.

China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. For manufacturers and distributors of drugs and medical devices in China, it is important to pay close attention to the pace at which CFDA implements these changes and makes additional changes to their operating procedures.

This webinar with expert speaker Robert J. Russell will specifically focus on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in China. The session will also include descriptions of the methods by which regulators in the CFDA process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Session Highlights:

  • The Regulatory Structure in China.
  • Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
  • How to begin your company’s involvement in China: local licenses, personnel and facilities required.
  • Clinical Trials: Why China? CFDA’s requirements, the Application Process, CRO Selection and Start-up.
  • The current key regulations effecting product development and your company’s product pipeline.
  • Pricing establishment.
  • Understanding the local concerns and specific challenges in working with Chinese Regulatory Personnel.
  • Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding China to your company’s global market presence.
  • Information necessary for effective dossier preparation; or how does one take an already approved dossier and turn it into an acceptable submission package.
  • Strategies for streamlining the registration application process for faster approval.
  • Maintenance of Authorized Products: Variations & Amendments to Licenses

Session Agenda:

  • Country Profile / Healthcare System.
  • Key Country Information.
  • Strategic Considerations: Why China? / Asia Structure / Hub Locations.
  • Governmental & Regulatory Authorities / Agencies / Structure.
  • Company Establishment; Licenses & Key Personnel.
  • Partner Companies / Local Relationship Options.
  • In-Country Operational Considerations; Importance of Local Distributors.
  • Requirements to Conduct Clinical trials / Approvals / GCP.
  • Licensing Products (Innovative Drugs, Generics / Similars, Orphan Drugs, Biologics / Vaccines, Medical Devices).
  • Variations and Amendments to Licenses.
  • GMP and Inspections.
  • Packaging and Labeling.
  • Price Establishment.
  • Reimbursement.
  • Import / Export / Customs Clearance.
  • Taxes / Duties.
  • Advertising & Promotion.
  • Vigilance Reporting / Post-Marketing Requirements.
  • Patents & Trademarks.
  • Local Customs / Cultural Issues / Establishing Business Relationships.
  • Working with Local Agencies / Authorities.
  • Conclusions.

Who Should Attend:

  • Regulatory, Quality, Manufacturing, Global Business Development and General Management personnel whose responsibilities require knowledge of China’s regulatory, quality and import / export requirements.
  • Administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements will also find this training highly relevant.
  • Global business development and general management requiring an understanding of how regulations and compliance issues are culturally handled along with how best to consider China into one’s Global Business Strategy will profit from attending.

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About Our Speaker

Robert J. Russell

Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.


Today, Robert assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations...   More Info
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