17 measures to improve drug administration in Shanghai
On March 12, the Shanghai Municipal Drug Administration unveiled 17 measures aimed at fostering a premier business environment within the pharmaceutical sector. Below is an overview of these measures.
Enhance registration services
The administration is committed to refining the review and approval processes for drugs, medical devices, and cosmetics to bolster the industrialization of innovative research and development outcomes.
1. Expedite the registration of drugs and medical devices to facilitate quicker market access.
2. Optimize registration guidance for innovative medical devices.
3. Enhance early guidance services for cosmetic innovation.
4. Provide comprehensive service packages for key enterprises to augment the success rate of registrations.
5. Utilize workstations to provide specialized registration guidance.
6. Enhance support for clinical trials, thereby accelerating the market introduction of innovative drugs and medical devices.
7. Explore policies to supply international cruise ships with drugs and medical devices during their stay at Shanghai ports.
Facilitate cost reduction
Aiming to lessen the operational costs for enterprises, the administration is implementing pilot reform initiatives effectively.
8. Advance segmented production strategies for biological products, targeting those with established production methodologies that are in urgent clinical demand, as well as innovative biological products necessitating unique processes or specialized equipment.
9. Advance the industrial application of continuous manufacturing technology for drugs.
10. Streamline supplemental new drug applications to reduce processing times for chemical drugs.
11. Optimize the registration processes for Class II medical devices and drug re-registrations.
By the end of 2024, Shanghai aims to reduce the average technical review duration for the initial registration of Class II medical devices to 55 working days, ensuring that the entire process from submission to approval does not exceed 7 months.
Moreover, the administration advocates for the local manufacturing of medical devices that have received import approval, offering guidance to facilitate a more efficient registration and review process for products manufactured within the city.
12. Improve the intelligence of government services through smart technologies like OCR and AI for faster processing of administrative licenses.
Improve supervision
To foster a more collaborative and effective supervisory environment, the administration introduces the following measures:
13. Deepen cross-departmental supervision of retail pharmacies to ensure comprehensive oversight.
14. Strengthen supervision collaboration within the Yangtze River Delta, promoting data, resource and information sharing, and mutual recognition of regulatory outcomes for drugs, medical devices, and cosmetics.
15. Implement credit-based categorized supervision, with exemptions and reduced inspection frequencies for high-credit entities.
For drug manufacturers classified as low-risk and holding an A-level credit rating, routine inspections will be waived, necessitating only a single routine inspection every three years. Additionally, these manufacturers are required to undergo just one GMP compliance inspection within five years.
16. Enhance guidance on regulatory compliance, bolstering pre-event risk warnings, and improving the quality of supervisory inspections by combining traditional on-site checks with innovative remote smart supervision techniques.
17. Improve in-process and post-event supervision, introducing leniency for first-time minor violations and promoting a more forgiving approach for minor infractions in the pharmaceutical sector.
Source: yjj.sh.gov.cn