The National Medical Products Administration (NMPA) has released draft “Online Third-party Drug Exchange Platforms Inspection Guidelines” for public review, with feedback accepted until September 15, 2023. These guidelines are designed to provide a framework for drug regulatory authorities to supervise and inspect enterprises offering third-party platform services in the pharmaceutical sector.
Routine Inspection Key Considerations
The draft guidelines highlight several key areas for routine inspections, including:
- Enterprises new to conducting third-party platform business in the pharmaceutical industry.
- Companies without a background in pharmaceutical distribution.
- Businesses with a large scale, extensive coverage, and significant volume of transactions.
Inspection Locations and Scope
The primary focus of inspections will be the registered address and business premises of the enterprises engaged in third-party platform business. However, if required, the inspection can be extended to include other relevant premises.
Inspection Implementation and Methods
The implementation of the inspection process, including the organization, institutions, personnel, procedures, and handling of results, will adhere to the “Drug Inspection Management Measures (Trial)” and other relevant requirements. Inspection teams may opt for on-site and/or off-site methods based on the work demands. Regions are encouraged to explore innovative inspection methods such as “combining online and offline” and “cross checking”. Additionally, the use of technical tools like “leveraging online third-party platform companies to manage the online sphere” is recommended to enhance the effectiveness of inspections.-Fineline Info & Tech
