Shanghai has introduced new measures designed to accelerate the temporary import of urgently needed medicines and medical devices, aiming to better address residents' clinical needs.

Outlined in the "Shanghai Guiding Work Plan (Trial Implementation) for Temporary Import Services of Clinically Urgently Needed Drugs and Medical Devices", the measures seek to establish a service system driven by clinical demand, coordinated by medical institutions, and supported by related government agencies.

Under the plan, qualified medical facilities within Shanghai can submit requests for temporary imports of vital drugs to the Shanghai Medical Products Administration and the Shanghai Municipal Health Commission. Requests for medical devices are submitted directly to the Shanghai Medical Products Administration.

Both the Shanghai Medical Products Administration and the Shanghai Municipal Health Commission are responsible for guiding the medical institutions on preparing the necessary application materials.

For medicines, the Shanghai Municipal Health Commission will organize evaluations by experts to assess the applicant institution's capabilities, the urgency of the drug's need, and the rationale for the requested amount. The commission then reports the written assessment to the National Health Commission, which provides guidance for the evaluation.

For medical devices, the Shanghai Medical Products Administration conducts initial assessments, offering guidance on the institution's competence, the urgency of the need, and the required quantity, under the guidance of the National Medical Products Administration.

A key feature of the plan is the simplification of evaluations for recurrent import requests. In situations where a medical institution is seeking to re-import a drug without any changes to the product, the initial evaluation can be reused, requiring only a reassessment of quantity.

A similar principle is applied to medical devices, permitting the reuse of the original joint assessment, with an emphasis on the required quantity.

The guidelines also aim to improve the efficiency of customs clearance. Medical institutions, after securing approval from the National Medical Products Administration to import the drugs, can request an "Import Drug Clearance Form" from the Shanghai Medical Products Administration in batches based on clinical demands, which the administration will issue within one working day. These imports are exempt from customs inspection.

For medical devices procured through medical device distributors, Shanghai Customs will expedite clearance procedures upon presentation of the National Medical Products Administration's approval.

The Shanghai Medical Products Administration will work with the Shanghai Municipal Health Commission to monitor adverse drug reactions and incidents involving medical devices, while Shanghai Customs will oversee inspection and supervision during the import process.

Medical facilities and businesses are responsible for the safety of the temporarily imported drugs and devices. This includes establishing clinical guidelines, safety protocols, quality management systems, and informed consent procedures.

They must also report any adverse reactions or safety concerns to the Shanghai Medical Products Administration, the Shanghai Municipal Health Commission, and Shanghai Customs.

Source: shanghai.gov.cn