Shanghai rolls out measures to boost pharma, medtech

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Shanghai has introduced a comprehensive policy that aims to strengthen its pharmaceutical and medical device sectors.

These measures aim to streamline regulatory processes, foster innovation, and promote the swift integration of new products into clinical practice.

Here is a breakdown of some key measures:

Accelerating application of innovative products

• Optimize listing services for newly launched drugs to make Shanghai the dominant location for new drug listings.

• Expand the scope of medical services and consumables covered by medical insurance to include more innovative products.

• Provide early guidance and pre-review for companies applying for pricing codes for innovative products.

• Ensure that newly listed drugs and medical devices are procured and put to use within one month after being added to the national medical insurance and the catalog of "innovative and excellent" products.

• Develop efficient mechanisms to connect research and usage of "innovative and excellent" drugs and devices, reducing hospital admission processes for critical new drugs from 30 to 15 working days.

• Accelerate the inclusion of eligible "innovative and excellent" products in medical insurance and encourage commercial health insurers to expand coverage for these products.

• Explore simultaneous settlement of medical and commercial insurance in pilot medical institutions to expand payment pathways.

• Formulate guidelines for the temporary import of urgently needed clinical drugs and devices.

• Explore early import channels of unregistered rare disease drugs and devices for specific medical institutions.

Promoting reforms in pharmaceutical sector

• Support reducing clinical trial review and approval times for eligible innovative drugs to 30 working days, advancing successful pilot experiences.

• Utilize a big data supervision platform for drug clinical trials to enhance trial quality and efficiency.

• Reform the review and approval process for supplementary applications for chemical drugs and provide pre-service support for major drug change declarations, shortening approval times to 60 working days.

• Accelerate the listing of first generic drugs and support pilot projects for supplementary applications for overseas-manufactured drugs and for generic drug dossier reviews.

• Improve processes and guidelines for changes to already listed drugs, combining site change inspections with registration reviews and compliance checks.

• Select eligible products for phased production trials of biological products and facilitate cross-border phased production trials for major foreign investment projects, offering facilitation for customs clearance.

• Explore continuous manufacturing pilot projects for pharmaceuticals.

Note: The above content is for reference only. In case of any discrepancies, the Chinese version shall prevail.