Sourcing or importing the IMPs and their supportive products is a challenging process for many researchers and this is more prominent with the countries like Japan and China where understanding the regulatory is difficult due to the language barriers and rapid changing norms for making imports.
Many key players in logistics are unclear about the confirmed regulatory process for the importation of IMPs and their supportive products. This would be because of rapid changes in the regulations for import and unclear regulatory scenarios.
So let’s discuss some challenges involved in the import of IMPs and their supportive medical products.
Challenges for importing IMP into China
- Stringent custom inspections where custom officials verify that material referred to in the import permit matches with the actual kits and packages that arrive for import.
- Uncertain and unclear Import/Export regulations.
- Multiple certifications and documents required for the importation which may consume more time and costs.
- Varying regulations for each product required for import.
- Language barriers.
- Unpredictable timelines for the import process.
Regulatory for IMP importation in China
- The National Medical Products Administration (NMPA) (CFDA) is the regulatory authority that oversees the import of IMP and issues the Import License.
- Before each import, the importation shall be notified to the local authority which issues the custom clearance for import.
- All the documents need to be translated into Mandarin.
- Upon issuance of the import permit, the sponsor needs to complete the process of importation within a limited time.
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 completing the process of selection before 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.
Clinical Trial Notification
- The applicant must submit relevant research materials according to the application requirements to the NMPA.
- NMPA and CDE have begun accepting applications and safety reports in the format provided in ICH guidelines during clinical trials.
The requirements for the clinical trial application include Investigator’s Brochure, Clinical trial protocol, Informed consent form, Pharmacy research information, Pharmacology and toxicology information, etc.
After formal review, if the application materials meet the screening requirements, they will be accepted. CDE organizes pharmaceutical, medical, and other technical personnel to review the accepted clinical trial applications for drugs.
The clinical trials are required to be conducted after review and approval by the Ethics Committee.
Within 60 days from the date of acceptance of the clinical trial application, the applicant will be notified about the approval result through the Drug Evaluation Center (CDE) website.
If an applicant does not receive any notification within the time limit, the clinical trial can be conducted according to the submitted protocol.
The documents required for the import permit include
- Certificate of Assessment (CoA).
- Certificate of Compliance (CoC).
- Certification of Manufacturing Facility Clinical Trial Application (CTA).
- Certificate of Origin (CoO).
- First leg airway bill.
Who handles your import?
To initiate the clinical trial on time along with all the required approvals you also need to have the IMPs and the supportive products by time. For this, you need a service provider who handles the import and takes care of the delivery of shipment on time to the clinical trial sites.
In the scenario of importation, either a CRO can handle all the services right from conducting a clinical trial to delivering the clinical trial shipment to the sites or the sponsor may appoint an IOR who can handle such importation.
Importer Of Record (IOR)
Depending on the scope of services and other terms, the sponsor in some instances may appoint an Importer Of Record (IOR) to handle the customs clearance and import related formalities. These formalities include
- Review of IMPs and their supportive products.
- Obtaining all the necessary documents required for importation.
- Paying all the duties and taxes for importations.
- Managing the shipment and transferring them to the clinical trial sites from the depot.
Labeling and packing
Packing is another place where attention to detail is imperative. The packing shall include the number of pieces, net weight, and gross weight. The boxes or thermal container system (TCS) need to be selected in advance for the contents. It is highly important that the labeling and packing are exactly the same as per the customs requirements and standards to avoid delays and rejections at the customs.
The CIQ inspection and the customs clearance are critical for importation In China. It’s recommended to have all the documents and the requirements in place before making the actual importation.
The port of shipment and the port of import are also some considerations while making importations. The port of import may depend on the location of clinical trial sites, flexibility for the distribution of shipments, etc. The customs regulations are almost the same with all the ports but however, it’s imperative to check with the regulations before making such importations. The goods if don’t fulfill the requirements may be sent back to where they came from.
Depot & Distribution
Most of the time the airline shipments are recommended to avoid delays and for the better management of controlled temperatures. The goods need to be shipped as early as possible to the depots. Having a depot is mandatory in China and immediately after customs clearance, the shipments need to be transferred to the depots.
These are the brief outs related to the import of IMPs and their supportive products into China. If you have additional queries please fill out the form below to connect with us.