China Regulatory Compliance for Life Sciences

Why Should You Attend:

China has been improving its’ regulatory regime governing the food and pharmaceutical industry in recent years. By promulgating the amended GMP and amending GLP, GCP, GSP and other regulations, China will further align the country with international standards of practice. For manufacturers and distributors of drugs and medical devices in China, as well as importers, it will be important to pay close attention to the pace at which NMPA implements these changes.

This course specifically focuses 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. Content will also include descriptions of the methods by which regulators in the NMPA process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Learning Objectives:

This webinar is designed to provide an overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of Life Science Products (pharmaceuticals, medical devices, biologics, combination products) as an importer into China. It will provide training on:

• 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? NMPA’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 and how does one take an already approved CTD 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

Areas Covered in the Webinar:

• 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 Will Benefit:

This course will be beneficial to:

• 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.
• 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.

Robert J Russell
President, RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.

Topic Background:

In 2019, the Chinese government established a single drug regulatory authority (The National Medical Products Administration, NMPA) as 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 NMPA (ex-CFDA, ex-SFDA) now oversees all medications. Other former functions of the ministry have been assigned to different government bodies. China has also amended GMP, GLP, GCP, GSP and other regulations to further align the country with international standards of practice (eg. ICH). For manufacturers, distributors and importers of drugs and medical devices into China, changes to standard operating procedures will be required, to ensure compliance with the evolving regime.

• China’s NMPA continues to make Regulatory Requirement changes at a relatively fast pace. Changes have been proposed and implemented in Drug & Biologics Licensing, Medical Device Registrations, Drug Master Files and have been proposed for Dietary Supplements approved by NMPA. This 90-minute webinar will update you with several of these changes.

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