Notice to Users of Serbia's Medicines and Medical Devices Agency August 2, 2024

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Starting August 2024, the Agency for Medicines and Medical Devices will begin processing certain requests through the RIMS system. From August 5, this includes documentary quality control requests for drugs, and from August 12, it will expand to include various clinical trial-related requests, such as importing drugs for trials and reporting on clinical trials.

Three Important Points:

1. Implementation Date: Requests will begin transitioning to the RIMS system on August 5 and August 12, 2024.
2. Types of Requests: Initial requests include documentary quality control for drugs, followed by requests related to clinical trials, including imports, changes, and reporting.
3. RIMS System Use: The shift to the RIMS system aims to streamline and centralize the submission and processing of these requests.

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Supplementary Notice: Adjustment of Pre-Acceptance Consultation for Medical Devices

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To further support the development of China's medical device industry, Hebei, Shandong, and Hubei Medical Device Innovation Service Stations have been added as participating units for pre-registration technical consultations. These consultations will begin on August 12, 2024, offering high-quality guidance to local medical device manufacturers. Consultations will be held every Thursday, with specific times and locations provided by each service station.

Three Important Points:

1. New Service Stations Added: Hebei, Shandong, and Hubei Medical Device Innovation Service Stations are now included in the pre-registration technical consultation process starting August 12, 2024.
2. Consultation Availability: Consultations will be available all day every Thursday, with specific times and schedules provided by each service station.
3. Target Audience: The consultations are aimed at domestic Class III medical device developers and manufacturers, as well as companies registered in China for imported medical devices.

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Notice to PRHs: Revised Categories & Criteria for New/Additional Indication Applications – Pilot Study

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The NPRA is expanding its reliance approach to include new/additional indication applications through a 12-month pilot project starting on August 1, 2024. The project involves revised categories and criteria, as detailed in Appendix I. While NPRA aims to test new processes, they are also managing a high volume of variation applications with the same resources, making applicant cooperation crucial.

Three Important Points:

1. The pilot project will test new categories and criteria for new/additional indication applications over 12 months, starting August 1, 2024.
2. The NPRA is handling both the pilot study and a high volume of variation applications, so applicant cooperation in planning and scheduling is essential.
3. Applicants should consult the respective head of sections for any queries related to the pilot project.

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