In the journey of international pharmaceutical registration, the European market has always attracted much attention due to its strict regulations and large consumer base. For pharmaceutical companies, submitting drug-related applications to Europe is a crucial step towards entering the international arena. The European Common Submission Portal (CESP) plays a vital role in this process. Today, we will share detailed experiences on European CESP submission, covering key contents such as the scope of countries for CESP submission and the detailed steps of CESP submission.
Scope of Countries for CESP Submission
CESP is applicable for submitting drug-related applications to multiple European countries, covering EU member states and some European Free Trade Association (EFTA) countries. Specifically, EU member states include Germany, France, Italy, the Netherlands, Belgium, Luxembourg, Denmark, Ireland, the United Kingdom, Greece, Spain, Portugal, Austria, Finland, Sweden, Poland, the Czech Republic, Hungary, Slovakia, Slovenia, Estonia, Latvia, Lithuania, Malta, Cyprus, etc. EFTA countries such as Norway, Iceland, and Liechtenstein are also within its scope of application.
Tips: After Brexit, submissions to the United Kingdom need to be made separately through the Medicines and Healthcare products Regulatory Agency (MHRA) and are not covered by CESP; although Switzerland is a European country, it has not joined the organizations, so submissions to Switzerland need to be made separately by contacting Swissmedic.
Through the CESP platform, pharmaceutical companies can communicate centrally with the drug regulatory authorities of these countries, realizing "one submission" with applications delivered to all required regulatory authorities, which greatly improves the efficiency and convenience of the application process.
Detailed Steps of CESP Submission
1. Create and Download the Delivery File
1) Log in to the official CESP website (https://cespportal.hma.eu/) using a registered CESP account.
2) Find the "New Delivery File" function entry on the left side of the platform interface and click to enter the "New Delivery File" creation page.
3) Fill in the following key information in four steps on this page:
Step 1:
a) Area: Select the corresponding area (e.g., EDQM, Human Medicine) in the "Area" section.
b) Submission Type: Select the submission type (Regulatory Activity & Sub Activity) based on the actual situation, such as Variation, Renewal, Response to Request for Additional Information, etc.
c) Zip File Type: Options include Microsoft Compressed File, 7-Zip, WinZip, etc.
d) Comments: Enter information related to the submission in the "Comments" box, and at least describe the key contents of the submission. For example, "This is a new CEP application for [substance name]."
Step 2:
a) Procedure Type: Select the corresponding procedure type in the "Procedure Type" section, such as National, MRP, DCP, CP.
b) Submission Format: Select the type of dossier in the "Submission Type" section, such as e-CTD, Nees, vNees, etc.
c) Validation Status: Indicate whether the submission dossier has been validated and which validation software was used.
Step 3:
a) Regulatory Authorities: Select the drug regulatory authorities involved in this submission.
Step 4:
a) Email Addresses: Enter the email addresses of recipients other than the account creator in the "Additional Email Addresses" section, which are mainly used to receive confirmation emails for successful submission.
b) Product Information: After selecting the regulatory authorities, enter the corresponding product name and MAA number.
c) Click "Submit"; once the system generates the delivery file, download and save it locally.
Tips:
Ø The delivery file cannot be edited: Once created, no content can be edited or modified. If information needs to be changed, a new delivery file must be created.
Ø The delivery file cannot be renamed: The file name after downloading must retain the system's default format (e.g., "CESP_Submission_XXXXXXX.xml"). Renaming will cause the system to fail to recognize it, leading to submission failure.
Ø The delivery file cannot be reused: A separate delivery file must be created for each submission, and historical files cannot be reused.
2. Upload Submission Data
1) Compress the Submission output: Compress the prepared eCTD output into a compressed file that meets the requirements (e.g., WinZip or Microsoft Compressed Folders format).
2) Upload the Compressed File: Find the Zip file upload function (Web Upload) on the CESP platform, click to enter the upload interface, and drag the compressed file to the designated area. Maintain a stable network connection during the upload process, and monitor the progress bar until it reaches 100% without error prompts. If the upload fails, troubleshoot and resolve the issue based on the error information prompted by the platform, such as incorrect file format or exceeded file size limit.
3) Upload the Delivery File: After the compressed file is successfully uploaded, continue to drag and upload the delivery file to the upload interface.
Tips:
Ø Upload Order: First upload the compressed file, and ensure it is completely uploaded before uploading the delivery file. This is because the system will automatically trigger the "data sending" command after the delivery file is uploaded, and the process cannot be revoked.
Ø Size Limit: Although the CESP platform does not explicitly announce a specific size limit for submission, in practice, excessively large files may lead to problems such as prolonged upload time and network interruption.
3. Confirm Submission Result
After the compressed submission data and the delivery file are successfully uploaded, the recipient's email will usually receive two confirmation emails.
One email, titled [Submission Upload Notification for CESP_Submission_1069583.xml], informs that the submission data has been uploaded to the CESP server.
The other email, titled [CESP Agency Notification – A New Submission File named CESP_Submission_1069583.xml has been uploaded to HA], confirms that the submission data has been successfully sent to the corresponding drug regulatory authority. This process usually takes less than one hour, depending on factors such as the size of the submission data.
Beijing BrilliantMed Pharmaceutical Technology Co., Ltd. has rich experience in EU pharmaceutical registration, including extensive experience in European CESP submission. If you have needs for European registration or encounter obstacles in the process, please feel free to contact us to obtain a customized solution and accelerate your market access.
