ComplianceOnline, Online Event
Why Should You Attend:
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.
This 3-hr 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 SFDA process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Areas Covered in the Seminar:
- 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.
- 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.