NMPA") issued the "Action Plan for Accelerating Drug Smart Supervision (GUO YAO JIAN ZONG 2019, No.26)"..." /> China to accelerate the development of "Smart Supervision System" for drug and medical devices - bio-talk.law

China to accelerate the development of “Smart Supervision System” for drug and medical devices

Healthcare 5 min
June 20, 2019

On 23 May 2019, the National Medical Products Administration (“NMPA“) issued the “Action Plan for Accelerating Drug Smart Supervision (GUO YAO JIAN ZONG 2019, No.26)(“Drug Smart Supervision Plan“), aiming to deepen the development of a drug supervision system embracing modern information technologies such as cloud computing, big data, and “Internet+” technologies.

Even before the Drug Smart Supervision Plan was issued, some provincial drug administrations had taken steps to digitise information. [1] For example, Jiangsu drug administration implemented their “Food and Drug Safety Smart Supervision and Big Data Project” in 2017 ,  establishing a local food and drug supervision database covering food, dietary supplements, drugs, medical devices, cosmetics and information on administrative approvals, inspections, reviews, certifications, testing and administrative penalties.

The Drug Smart Supervision Plan sets even bigger goals. The key points include:

  1. Establishing drug supervision cloud platforms. The goal is to build up national level and provincial level drug supervision cloud platforms by upgrading the existing infrastructure and integrating existing hardware, to achieve interconnection and information sharing between the national and provincial drug supervision systems.
  2. Constructing e-government internal and external networks. The NMPA external network will be connected with the state e-government external network to enable interconnection with other central government authorities and regional supervision departments. The China Customs has had, since March 2019 access to the Drug Import/Export Permits and Imported Drug Customs Clearance Forms issued by the NMPA to assist in their Customs clearance process.
  3. Improving drug regulatory information standard system.The Drug Smart Supervision Plan encourages China’s involvement in international standard setting to ensure national drug supervision information standards are aligned with the international standards.
  4. Establishing data management system and drug supervision data sharing platform. While many provinces have existing drug supervision databases, information contained in these databases are not accessible by other local drug administration authorities, often impeding the speedy recall of unsafe drugs.The Drug Smart Supervision Plan’s aim is to develop the relevant data collection, analysis, processing and access mechanisms to form a comprehensive database which can be accessedin real- time by state and provincial drug supervision authorities.
  5. Establishing a product life-cycle management system covering drugs, medical devices and cosmetic products.This will be implemented by compiling and linking the same product information managed by different departments of the relevant authorities to form product portfolios for each variety and each manufacturer.
  6. Strengthening data application and cooperation. The drug supervision authorities at all levels are encouraged to cooperate with other government authorities, universities, research institutions, other market players, etc., to expand data resources.
  7. Constructing the state drug regulatory application platform. The platform will incorporate a consolidated portal user management system that covers the management of information regarding administrative approval, supervision, testing, inspection and risk analysis for drugs, medical devices and cosmetics.
  8. Constructing the “Internet + government service” platform. The aim is to develop a “one-stop service” by integrating the online and offline government services.The online services will allow the public to have easy access to the relevant information via the government authorities’ websites, users’ mobile phones etc., which will further increase transparency of regulatory information and facilitate the online processing of drug management matters.
  9. Constructing the drug traceability resources sharing service and supervision system. The NMPA will establish a drug traceability resources sharing platform, providing general information of drug manufacturers and drug products, recordal and management of drug traceability codes as well as the websites of different drug traceability systems. The NMPA will also set up a state drug traceability supervision system to track down and monitor the supply, distribution, urgent recalls and allocations of drugs.
  10. Constructing the national drug supervision electronic certificates database. NMPA will improve the supervision and management of electronic certificates and build up a system to manage and verify electronic certificates.
  11. Developing a comprehensive confidentiality review system to protect national secrets, commercial secrets, and personal data.
  12. Constructing a trustworthy supervision system, including application of multiple authentication means such as E-identification and smart ID authentication.
  13. Constructing a mobile application management platform to provide companies and individuals with convenient service channels.

After one year of preparation, on 5 May 2019, NMPA launched a pilot scheme named “Medical Device Manufacturers Administration Information Platform”. The platform initially covers 17 provinces and is scheduled to be fully operational nationwide by Q4 2019.  Under this platform, data relating to medical devices regulations will be accessible and among other features, the system will be able to automatically generate inspection plans matching the inspection requirements for the corresponding medical devices products of the manufacturers and setting a timetable for the inspection. The system also allows random selection of inspectors.  In April and May 2019, we have also seen the release of regulatory standards such as the Guidelines for Drug Traceability Information System Construction“, “Drug Traceability Coding Requirements“. and Basic Dataset for Vaccine Traceability (Draft for Comments).

China has been actively developing a drug supervision mechanism with “big system, big platform and big data”, and we look forward to see more details of the implementation of the action plan in the future.

[1] In 2015, the Yangzhou drug administration required local medical device manufacturers to install a remote supervision system in their major production workshops to enable real-time cleanliness data to be uploaded to the relevant database. If the uploaded data did not meet the required standards, an alert would be sent to the Yangzhou drug administration officer’s mobile phones, so that the authorities could take further action. Further information at this link here.

Written by
Alison Wong
Alison Wong
As a partner in our Intellectual Property Group in Hong Kong and head of our Life Sciences & Healthcare Sector Group in Asia, I have 20 years' experience in advising clients in the life sciences, healthcare, food & beverage and retail & consumer sectors.
Yang Li
Yang Li
As a legal manager in our Intellectual Property team at Bird & Bird in Hong Kong, I regularly advise clients on a wide range of contentious and non-contentious intellectual property matters.

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