Regulations of Shanghai Municipality on the Administration of Drugs and Medical Devices

(Adopted at the 18th Session of the Standing Committee of the 16th Shanghai Municipal People's Congress on December 31, 2024)

Chapter I General Provisions

Article 1

With a view to strengthening the administration of drugs and medical devices, ensuring the qualities of drugs and medical devices, promoting the innovation and development of drugs and medical devices, and safeguarding the public health and safety, these Regulations are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Traditional Chinese Medicine Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices, the other laws and administrative rules, and in the light of the actual circumstances of this Municipality.

Article 2

These Regulations apply to the research, production, distribution, use and supervision of the drugs and medical devices within the administrative areas of this Municipality.

Article 3

The administration of drugs and medical devices in this Municipality shall be centered on the public health, adhere to the principles of risk management, full-process control, scientific supervision, social co-governance, encouragement of innovation and service development, ensuring the safety, efficacy and accessibility of the drugs and medical devices.

Article 4

The municipal and district people's governments shall be responsible for the administration of the drugs and medical devices within their respective administrative areas. They shall provide unified leadership, organization and coordination for the administration of the drugs and medical devices, and shall respond to the emergencies, establish and improve management mechanisms and information-sharing systems, incorporate the drug and medical device administration into the state economic and social development plans, strengthen regulatory capacity construction, and provide guarantees for the safety of the drugs and medical devices.

Article 5

The Food and Drug Safety Committees established by the municipal and district people's governments shall specifically undertake the work of research, arrangement and overall planning of the safety of drugs and medical devices, urging the implementation of the safety management responsibilities, coordinating the handling of the major drug and medical device safety incidents, major law violations and the other duties granted by the municipal and district people's governments.

Article 6

The municipal drug regulatory departments and the departments responsible for the drug regulations of the district people's governments (hereinafter collectively referred to as the drug regulatory departments) shall be responsible for the supervision and administration of the drugs and medical devices within their respective administrative areas.

The health, medical security, science and technology, commerce, market regulation, intellectual property, ecology and environment, agriculture and rural affairs departments shall jointly perform the relevant management duties according to their respective responsibilities.

Article 7

Those engaged in the research, production, distribution and use of drugs and medical devices shall comply with the relevant laws and administrative rules, meet the requirements for non-clinical research, clinical trials, clinical evaluation, registration (filing), production management, distribution and use management and biological safety.

Article 8

The drug marketing license holders, medical device registrants or filers shall establish quality management, risk prevention and control and safety incident handling systems, and shall be responsible for the safety, efficacy and quality control of the drugs and medical devices according to law.

Article 9

The industry organizations related to drugs and medical devices shall provide information, training and technical services to their members, establish and improve the industry standards, strengthen the industry self-discipline and integrity construction, guide their members to carry out the drug and medical device-related activities in accordance with the laws, and promote the healthy development of the industry.

Article 10

This Municipality shall establish communication and cooperation mechanisms with the relevant provinces and cities in the Yangtze River Delta region for the administration of drugs and medical devices, strengthen cooperation in the fields of review and approval, regulatory enforcement, credit management, risk prevention and control and emergency response, and promote the construction of a regulatory system of unified standards, data exchange, mutual recognition of results, and joint operation and coordination for the drugs and medical devices in the Yangtze River Delta region.

This Municipality shall support the exchanges, cooperation and coordinated development with the other domestic regions in the field of drugs and medical devices.

This Municipality shall strengthen the international exchanges and cooperation of drugs and medical devices, promoting the research and development innovation and industrial internalization.

Chapter II Research, Development and Innovation

Article 11

This Municipality shall encourage the research and innovation of drugs and medical devices, support the basic and applied research to promote original innovation.

Enterprises, research institutions, medical and health institutions, and institutions of higher education shall be encouraged to carry out the clinical value-oriented innovative research, integrate and share resources, and promote the transformation, promotion and application of new technologies.

Article 12

The clinical trial sponsors and clinical trial institutions conducting drug and medical device clinical trials shall comply with the procedures and requirements prescribed by the State, ensure that data and results are scientific, truthful, and reliable, and protect the rights and safety of the subjects.

The municipal drug regulatory departments shall conduct quality monitoring of the clinical trials, issue warnings for the potential safety issues or the other risks, conduct risk assessments, and handle them according to law.

The clinical trial sponsors shall be encouraged to conduct multi-center clinical trials for drugs and medical devices in different countries or regions; the clinical trial institutions shall be encouraged to participate in the international multi-center clinical trials for drugs and medical devices.

Article 13

This Municipality shall, in accordance with the provisions of the State, support the qualified enterprises, research institutions, medical institutions and institutions of higher education to cooperatively conduct clinical trials for the cell and gene therapy drugs, promote the effective accumulation of the real-world data, improve the quality and applicability of the data, and provide support for product registration.

The insurance companies shall be encouraged to develop insurance products covering the clinical trials for cell and gene therapy drugs; supports shall be provided for purchasing the insurance products suitable for clinical trials of cell and gene therapy drugs.

Article 14

The municipal science and technology departments shall, together with the municipal health departments and the other departments, establish a collaborative research and innovation platform to promote the clinical trial needs by the medical institutions docking the enterprises, improve the quality and efficiency of industry-medical integration, and accelerate the research and development of drugs and medical devices.

Article 15

This Municipality shall promote the establishment of a collaborative ethical review mechanism for the medical institutions, conduct multi-center clinical trial ethical collaborative reviews, and promote the mutual recognition of the ethical review results.

Article 16

The drugs and medical devices shall be registered and filed in accordance with the procedures and requirements prescribed by laws and administrative rules. The municipal drug regulatory departments shall optimize the technical guidance and communication services during the review and approval, inspection and testing processes.

The municipal drug regulatory departments shall strengthen pre-guidance for the registration of the drugs and medical devices with significant clinical values and high innovation, and cooperate in the coordination and guidance of the major biomedical industry projects.

The municipal drug regulatory departments shall, together with the municipal science and technology departments, guide the authority of industrial agglomeration areas to provide consulting and guidance services to the enterprises via the establishment of service stations and online services.

Article 17

This Municipality shall support the construction of the Yangtze River Delta Branch of the State Medical Products Administration's Drug Evaluation and Inspection Center and the Yangtze River Delta Branch of the Medical Device Technical Evaluation and Inspection Center, providing guidance services to the registration and filing applicants to accelerate their product registration and marketing.

Article 18

This Municipality shall strengthen the protection of the intellectual property rights for drugs and medical devices, improve the rapid patent review service mechanism for the innovative drugs and medical devices, and encourage the innovative research and development of drugs and medical devices.

Article 19

The Class II medical devices with significant clinical values and high innovation may be applied to the municipal drug regulatory departments for the innovative product registration procedures.

The Class II medical devices under any of the following circumstances may be applied to the municipal drug regulatory departments for the priority registration procedures:

1. for the diagnosis or treatment of rare diseases;

2. for the diseases specific to or prevalent among the elderly with no effective diagnostic or treatment methods currently available, or specifically for the children with significant clinical advantages;

3. no similar products having been approved for registration domestically and having significant clinical advantages, or few similar products having been approved domestically and unable to meet clinical needs;

4. those being included in the state major science and technology projects, the key research and development plans, or major science and technology projects and scientific and technological innovation action plans of this Municipality; 

5. and the other circumstances where the priority registration procedures may be applied.

During public health emergencies, the municipal drug regulatory departments shall include the Class II medical devices urgently needed for emergency response that have no similar products on the domestic market or whose supply cannot meet the emergency response needs in the emergency registration procedures.

The innovative product registration procedures, priority registration procedures and emergency registration procedures for the Class II medical devices shall be separately formulated by the municipal drug regulatory departments and filed in accordance with the relevant state provisions.

Article 20

This Municipality shall establish a clinical research system, strengthen the cooperation between the medical institutions, institutions of higher education, research institutions and enterprises, promote research on cutting-edge technologies in the fields of drugs and medical devices, and facilitate the transformation and application of the research results.

It is encouraged to construct research hospitals and research wards in this Municipality which shall be equipped with research teams suitable for clinical research. Clinical research management systems and evaluation incentive mechanisms shall be improved to enhance research capabilities and levels.

This Municipality shall encourage the clinical research to be conducted in accordance with the quality management standards for drug and medical device clinical trials, promoting the connection between the clinical research and clinical trial data to provide support for the product registration. Where the If the State has other provisions on the quality management requirements of clinical research, such provisions shall prevail

The municipal health departments shall strengthen the monitoring, evaluation and analysis of the clinical research and implement supervision and management.

Article 21

The municipal commerce departments shall, together with the municipal drug regulatory, ecology and environment, agriculture and rural affairs and science and technology departments, establish a joint promotion mechanism for the import of the items used in biomedical research and testing, optimizing the customs clearance processes for the biomedical research units, drug and medical device enterprises importing the raw materials, compounds and the other items used in the biomedical research that have not been approved for marketing as drugs domestically or abroad, as well as for the testing and monitoring institutions importing trace amounts of testing standard substances, so as to promote customs clearance facilitation.

The municipal science and technology departments shall, together with the relevant departments, implement joint supervision on the import and export of the special biomedical items in accordance with the provisions of the State and this Municipality, conduct comprehensive assessments, and optimize the customs clearance processes based on the assessment opinions to facilitate customs clearance.

Chapter III Production Management

Article 22

The municipal drug regulatory departments shall guide the qualified drug registration applicants to complete the pharmaceutical and pharmacological toxicology research to support the drug marketing registration, determine the quality standards, complete the commercial-scale production process validation, and submit applications for drug production licenses or additional production scope based on confirmed clinical trial data indicating safety and effectiveness.

Article 23

The medical device registration applicants applying for the transfer of medical devices with imported or domestic medical device product registration certificates to production within this Municipality shall complete the product registration and production licensing in accordance with the provisions.

The municipal drug regulatory departments shall optimize the declaration of production materials and on-site production inspection procedures to improve their review efficiency in accordance with their statutory duties.

Article 24

For the commissioned production of drugs and medical devices, the drug marketing licence holders, medical device registrants or filers shall sign quality agreements and commissioned production agreements with the commissioned production enterprises, strictly fulfilling the obligations stipulated in the agreements.

The drug marketing licence holders, medical device registrants or filers shall do a good job in the product release and management change upon post-marketing, regularly organize production quality risk assessments, and propose corrective and preventive measures to ensure that the production processes comply with the legal and quality control requirements.

The commissioned production enterprises shall organize production in accordance with the laws and rules, production quality management standards, mandatory standards, product technical requirements and commissioned agreements, and shall not sub-commission the production.

The drug marketing licence holders, medical device registrants or filers, and the commissioned production enterprises shall strengthen the effective connections in material acceptance upon arrival at the factory, production inspection, deviation and change control, and release review and so on.

Article 25

This Municipality shall, in accordance with the state provisions, explore the segmented commissioned production for the innovative drugs that have special requirements for production processes, facilities and equipment, for the clinically urgently needed drugs or the drugs urgently needed for public health emergency response.

For the implementation of the segmented commissioned production of drugs, the drug marketing licence holders shall establish a quality management system covering the entire process from research and development, production, inspection, to post-marketing monitoring and evaluation, implement unified management of the commissioned production activities at each segmented production site, so as to ensure that the production processes comply with the legal and quality control requirements.

Article 26

For the production of the cell therapy drugs conducted in accordance with the state provisions, the drug marketing licence holders and commissioned production enterprises shall establish a quality management system and a digital traceability system covering the entire process from material acceptance, production, inspection to the finished product release, storage, transportation and handover, and establish a risk assessment system to effectively identify the risk factors affecting the cell therapy drugs.

Article 27

This Municipality shall, in accordance with the state provisions, explore the marketing of the commercial-scale batch drugs that meet the criteria.

After passing the pre-marketing compliance inspection of the drug production quality management standards and obtaining the drug registration certificates, the drug marketing licence holders with drug production licenses may market the commercial-scale batch drugs in accordance with the state provisions. The drug marketing licence holders shall ensure that the aforementioned drugs meet the release requirements and shall strengthen the risk control.

For the import of the commercial-scale batches of the drugs already marketed abroad and meet the state provisions, the municipal drug regulatory departments shall issue drug import clearance documents in accordance with the law.

The municipal drug regulatory departments shall strengthen the supervision and management of the marketing of the commercial-scale batch drugs.

Article 28

The qualified medical device production enterprises sharing inspection and testing, process water, and gas facilities and equipment shall establish a unified production quality management system and maintain its effective operation, strengthen the daily management and quality control to ensure that the production and testing processes comply with the legal and standard requirements.

Article 29

This Municipality shall support the Chinese herbal medicine slices production enterprises to establish their planting and breeding bases in the genuine producing areas and main producing areas of the traditional Chinese medicinal materials, promote the standardized planting and breeding of the traditional Chinese medicinal materials, strengthen the quality monitoring, and ensure that the source quality of the Chinese herbal medicine slices.

The Chinese herbal medicine slices production enterprises shall establish a technical management system suitable for the characteristics of the Chinese herbal medicine slices, produce the Chinese herbal medicine slices in accordance with national drug standards and local processing specifications, make full-process records for the production, inspection, storage, and transportation of the Chinese herbal medicine slices to ensure the traceability of the information.

This Municipality shall encourage the intensive production of the Chinese herbal medicine slices, support the Chinese herbal medicine slices production enterprises to strengthen the research, development and application of related technology and, equipment, promote the informatization and intelligent upgrading of the production equipment, and improve the standardization level of the Chinese herbal medicine slices production processes.

Article 30

The Chinese herbal medicine slices production enterprises may, in accordance with the state provisions, purchase the fresh-cut Chinese medicinal materials from the production areas for the production of the Chinese herbal medicine slices.

The Chinese herbal medicine slices production enterprises shall extend the quality management system to the planting, harvesting and processing of the Chinese medicinal materials, ensure that the processing enterprises at the production areas produce the medicinal materials in accordance with the drug production quality management standards, and shall not directly package or repackage the purchased fresh-cut Chinese medicinal materials for sale.

Article 31

For the import of the medical devices in the China (Shanghai) Pilot Free Trade Zone and the Lin-gang Special Area, the domestic agents that meet the state provisions may, under the effective control of the medical device quality management system, affix the Chinese labels and place the Chinese instructions on their own or entrust the others to do so before sales or supply within the customs special supervision area, and they shall report to the municipal drug regulatory departments, accepting the supervision and inspection by the district-level drug regulatory departments where they are located.

The municipal drug regulatory departments shall strengthen cooperation with the relevant departments and share information.

Chapter IV Sale and Use

Article 32

The drug retail enterprises in this Municipality that sell the prescription drugs and Class A over-the-counter drugs shall, in accordance with the provisions of the State and this Municipality, staff licensed pharmacists, provide prescription review and rational drug use guidance, and also strengthen professional training for the licensed pharmacists. The headquarters of the drug retail chain enterprises may supplement pharmaceutical services for their retail enterprises through remote prescription review by the licensed pharmacists.

The licensed pharmacists shall be encouraged to join the community drug safety digital service platforms to provide public welfare pharmaceutical services to the public.

Article 33

The medical institutions shall carry out external prescription dispensing in accordance with the provisions of the State and this Municipality. The drug retail enterprises shall strengthen the review and management of the external dispensing prescriptions and retain them to ensure the traceability of the drug flow.

The municipal medical security and health departments shall promote the medical security designated medical institutions to carry out external prescription dispensing through the unified medical insurance information platform of the State, standardize the circulation of the electronic prescriptions to the drug retail enterprises, and strengthen their supervision.

Article 34

Those engaged in medical device financial leasing activities shall, in accordance with the provisions of the State, obtain medical device business licenses, establish a business quality management system suitable for their business scope and scale, so as to achieve product information traceability management, and ensure their quality and safety.

Article 35

The drug marketing licence holders, medical device registrants or filers, and the drug or medical device production and operation enterprises shall conduct training and assessment on drug and medical device quality safety and the relevant laws and rules for the relevant key personnel. The drug regulatory departments shall conduct random inspections on the implementation of the quality safety responsibilities by the relevant key personnel.

Article 36

The drug wholesale enterprises and medical device selling enterprises conducting multi-warehouse collaboration shall establish a unified quality assurance system, ensure the interconnection of the information systems, and collaboratively carry out the storage and distribution of the drugs and medical devices.

Article 37

The medical institutions that urgently need to import small quantities of drugs and Class II and III medical devices for clinical use may, in accordance with the provisions of the, import and use them for specific medical purposes within the designated medical institutions after approval. The medical institutions shall analyze the clinical data of the used drugs and medical devices, conduct safety and efficacy evaluations of their clinical use, and report to the municipal health and drug regulatory departments annually.

The drug and medical device enterprises shall be encouraged to strengthen cooperation with the medical institutions to conduct real-world data application research on the imported drugs in small quantities and medical devices urgently needed in clinic, and explore the use of the clinical real-world data for the drug and medical device registration.

For the rare disease drugs that require port inspection, the port drug inspection institutions shall optimize the sample quantities for inspection in accordance with the provisions of the State.

Article 38

The domestic agents designated by the overseas medical device registrants or filers in this Municipality shall assist the overseas medical device registrants or filers in fulfilling their obligations in accordance with the law.

The domestic agents of medical devices in this Municipality shall establish import medical device product ledgers and retain their files for future reference, and submit the self-inspection reports on the operation of the quality management system of the overseas medical device registrants or filers for the previous year to the municipal drug regulatory departments in the first quarter of each year.

Article 39

This Municipality shall support the medical institutions in preparing and using the traditional Chinese medicine preparations according to the clinical needs. For the varieties of traditional Chinese medicine preparations prepared by medical institutions, the medical institutions shall obtain their preparation approval documents or complete the filing in accordance with the law.

The medical institutions shall collect the human empirical data on the traditional Chinese medicine preparations and conduct evaluations, and submit the evaluation reports to the municipal drug regulatory departments annually.

The municipal science and technology, health, and drug regulatory departments shall support the transformation of the traditional Chinese medicine preparation varieties with definite efficacy, distinctive advantages and few adverse reactions into new drugs.

Article 40

The enterprises engaged in the sale of the cell therapy drugs shall establish specialized management systems for the quality management and information traceability.

The medical institutions using the cell therapy drugs shall set up the facilities and equipment that meet the requirements for the handover and acceptance of the cell therapy drugs, establish a sound handover and acceptance system, and maintain the process records for future reference.

The drug marketing licence holders shall conduct quality assessments of the medical institutions mentioned in the preceding paragraph. If clinical usage risks are identified, they shall promptly require the medical institutions to take corrective and preventive measures.

Article 41

The municipal medical security departments shall optimize the online transaction process for the innovative drugs and medical consumables on the centralized procurement platform.

The designated medical institutions under medical security shall promptly provide and use the corresponding innovative drugs and medical devices based on the clinical needs after the state medical insurance drug catalog and the catalog of new and high-quality biomedical products are updated and released.

Article 42

The medical institutions that entrust the relevant units to provide decocting services shall sign quality agreements with the entrusted units and strengthen the entire process management and quality control of the key links such as prescription review, formulation, decoction and dispensing of the Chinese herbal medicine slices.

The entrusted units shall comply with the quality agreements, provide decocting services in accordance with the service standards for the Chinese herbal medicine slices, and establish a full-process recording system and a quality tracking, tracing and monitoring system.

The municipal traditional Chinese medicine administration departments shall, together with the municipal drug regulatory departments and the other relevant departments, formulate the service standards for the decoction of Chinese herbal medicine slices. The municipal traditional Chinese medicine administration departments shall strengthen the supervision and management of the decocting services in the medical institutions, urging them to enhance their quality control during the entrusted decocting process. The drug regulatory departments shall strengthen the quality supervision and management of the Chinese herbal medicine slices used for decoction.

Article 43

The operators of online trading platforms for drugs and medical devices (hereinafter referred to as the platform operators) shall comply with the relevant provisions of the State and this Municipality on e-commerce, establish and improve a quality and safety system for the online transactions, and standardize the online trading activities of drugs and medical devices on the platform.

The platform operators shall establish inspection systems for the online sales activities of drugs and medical devices, conduct regular inspections and keep records on a timely manner, manage the information display, prescription review, sales and distribution acts of the drug and medical device online sales enterprises on the platform, and urge them to strictly fulfill their legal obligations. Where the platform operators discover illegal activities, they shall take necessary measures in accordance with the law and report to the drug regulatory departments.

The drug regulatory departments shall, in accordance with their duties, conduct supervision and management over the platform operators and drug and medical device online sales enterprises on the platform, carry out online sales monitoring, and strengthen the investigation and handling of the illegal activities.

The platform operators shall be encouraged to collaborate with the municipal drug regulatory departments through open data interfaces and the other forms to achieve automated information reporting, data sharing and coordinated governance.

Chapter V Supervision and Administration

Article 44

When carrying out supervision and administration, the drug regulatory departments shall comprehensively consider the product risks, the operation of the enterprise's quality management system and credit status, optimize their supervision methods, and improve their supervision efficiency.

Article 45

The drug regulatory departments shall coordinate and standardize the inspection and supervision of the drugs and medical devices, formulate the inspection procedures for the same inspection targets, integrate the supervision and inspection items, and reasonably determine their inspection frequency.

The municipal drug regulatory departments shall, together with the relevant departments, establish a coordinated supervision mechanism for the drugs and medical devices, and conduct joint supervision and inspection on the matters included in this Municipality's cross-departmental comprehensive supervision.

Article 46

Relying on the Government Online-Offline Shanghai platform for government services and the All-in-one Online Management platform for urban operation, this Municipality shall establish a digital supervision platform for the drugs and medical devices, strengthen the collection, sharing, analysis and utilization of the supervision information, enhance the informatization level of the whole-process supervision, risk warning and credit management, and achieve the intelligent supervision of the drugs and medical devices.

Article 47

The Municipality shall support the scientific research in the drug and medical device supervision. The municipal drug regulatory departments shall focus on the new technologies, models and formats in the drugs and medical devices, organize the universities, research institutions, medical and health institutions and enterprises to research on and apply new tools, standards, rules and methods for review, approval and post-market supervision, promote the research and development of the new products, and enhance the scientific supervision and service innovation capabilities.

Article 48

The drug regulatory departments shall, in accordance with the requirements of the State and this Municipality, establish a professional and specialized team of drug and medical device inspectors to inspect the implementation of the quality management standards in the research, production, distribution and use of the drugs and medical devices, providing technical supports for the administrative law enforcement.

The municipal drug regulatory departments shall strengthen professional training for the inspectors and may collaborate with the universities and research institutions to cultivate the inspectors capable of participating in the international drug and medical device regulatory affairs.

Article 49

The drug regulatory departments may conduct the quality evaluation sampling and production quality management system assessments for the specific categories and innovative drugs and medical devices on their own or by entrusting the professional technical institutions. Based on the sampling and assessment results, they shall conduct comprehensive analysis, and take corresponding management measures.

The drug regulatory departments shall inform the sampled or assessed units of the results of the quality evaluation sampling and production quality management system assessments.

Article 50

The municipal drug regulatory departments shall establish and improve a monitoring network for the adverse drug reactions and medical device adverse events, improve the working system, and handle the adverse reactions and adverse events in accordance with the law.

The marketing licence holders of the drugs, the registrants or filers of the medical devices, as well as the drug or medical device manufacturers, operating enterprises and medical institutions, shall perform their obligations to monitor the adverse reactions and adverse events in accordance with the law and report the monitoring information in a timely manner.

The municipal drug regulatory departments shall, together with the municipal health departments, designate the medical institutions and operating enterprises as the monitoring sentinels for the innovative drugs and medical devices and the other key monitoring products. The monitoring sentinels shall actively collect the information on the adverse drug reactions and medical device adverse events and report to the drug regulatory departments.

Article 51

The drug regulatory departments shall establish the regular and special consultation mechanisms for the drug and medical device safety risks at the municipal and district levels, focusing on the key enterprises, products and links, collecting and identifying the risk information, comprehensively assessing the risk levels, and promptly taking targeted preventive and control measures. When necessary, the drug regulatory departments shall conduct risk consultations with the relevant departments.

Chapter VI Legal Liability

Article 52

For the acts that violate the provisions of these Regulations, where laws and administrative rules already provide for handling, such provisions shall prevail.

Article 53

Where a medical institution violates the provisions of Paragraph 2 of Article 40 of these Regulations by failing to set up the facilities and equipment that meet the requirements, or by failing to establish a handover and acceptance system or keep the process records, the drug regulatory departments shall order it to make corrections within a prescribed time limit; if it fails to make corrections within the time limit or the circumstances are serious, a fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed upon it; if serious consequences are caused, a fine of not less than 50,000 yuan but not more than 200,000 yuan shall be imposed upon it.

Chapter VII Supplementary Provision

Article 54

These Regulations shall be effective as of March 1, 2025.