This China & Pacific Rim life science compliance-based seminar will discuss the regulatory structure and requirements for compliance with in-country regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. In 2010, 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, it is important to pay close attention to the pace at which SFDA implements these changes and to make changes to their standard operating procedures when necessary to ensure compliance with the evolving regime.
Other Pacific Rim markets are also growing in importance and interest in access to innovative products. In-country Regulatory Agencies are progressing in their sophistication, process development and regulatory requirements.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China and the listed Pacific Rim Countries* (Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand). The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies. Content will also include descriptions of the methods by which regulators process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
This course is designed to provide a detailed 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 & the Pacific Rim. It will provide training on:
- The current Regulatory Structure.
- Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
- How to begin your company’s involvement in-country: local licenses, personnel and facilities required.
- Clinical Trials: Why consider Country X? CTA 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 Local Regulatory Personnel.
- Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding China and countries from the Pacific Rim 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.
Who will Benefit:
This course will be beneficial to the following personnel whose responsibilities require knowledge of these Emerging Markets’ regulatory requirements for Life Science products:
- Regulatory, Quality, Manufacturing, Global Business Development and General Management personnel whose responsibilities require local knowledge of 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 & the Pacific Rim into one’s Global Business Strategy will profit from attending
The Chinese government’s establishment of a single drug regulatory authority in 2003 (The State 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 SFDA 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.
Along with it in 2010, China has amended GMP, GLP, GCP, GSP and other regulations, China’s aim is 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 SFDA 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.