IMPs and their supportive products are crucial for any clinical trial and timely delivery to the clinical trial sites matters a lot for trial initiation and conduction. Understanding the thorough regulatory is very important before making such import.
Most of the times import of IMPs and their supportive products are handled by the CROs who are conducting the clinical trials, but in some cases where the importation of IMPs and ancillary supplies is not under the scope of CRO, then the sponsor shall assign a service provider who handles these imports. But before handling the import, the sponsor or the importer need to know the complete import regulations.
For importing IMPs and their supportive products, you need to answer the following
What are the regulations for the import of IMPs and their supportive products?
The import of IMPs and their supportive products are completely overseen by the NMPA. You need to submit an application for import to the NMPA once approved this facilitates the customs clearance during import.
What are the requirements applicable to import IMPs?
The requirements for the import of IMPs are different from the requirements for the clinical ancillaries import. To import the IMPs and their supportive products you may require a Certificate of Analysis (COA), Certificate of Origin (CoO), Manufacturing Certificate (MC), certificate of compliance (CoC), etc. The requirements for each product may also vary.
Process of importation for IMPs and their supportive products?
The process of importation for IMPs and clinical ancillary supplies is not the same. For IMPs, you need to plan the import process before making a clinical trial application.
Responsibility for import for clinical trials
Since the importation is for clinical trial purposes, the responsibility of importation must be defined and authorized precisely. You need to authorize the right person at the right time and recommend to complete the process of selection before e making a clinical trial application.
Impact of various factors on the import process
Various factors come into place while making the actual importation. Factors like CIQ or customs clearance, the port of shipment, and port of import, time of import, etc play a crucial role in completing the process of import successfully.
Get Details on Regulatory Process, Requirements, and Aspects of Importation of Clinical Trial Ancillary Supplies.
With an increasing number of multi-site trials being conducted in different regions, we at Credevo, receive multiple queries asking for regulations and requirements of such importation. This may also be due to the fact that the information found on the internet could be incomplete, outdated, or at times unrelated. The practical scenario of regulatory compliance could have many more aspects to be considered.
Credevo has prepared a report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.
What would you get by downloading this report?
- Details on the regulations, requirements, and process to import IMPs and their supportive products into China.
- Free assessment of your IMPs and their supportive products by Credevo to check specific requirements that apply for import.
Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for importing IMPs into China. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared on the basis of relevant information from the public domain as of the date, however, the NMPA regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of importation.