On January 24th, Southern Daily published an article titled "Guangdong Provincial Drug Administration Deepens Drug Supervision Reform and Innovation, Striving to Promote Modernization of Drug Supervision in Guangdong". Let's take a look!

Striving to promote the modernization of drug supervision in Guangdong

Guangdong Provincial Drug Administration deepens drug regulatory reform and innovation

The land of Lingnan is full of spring tide and vitality.

The domestically produced anti-cancer new drug Ivo Xidan Anti Injection has been approved for market, filling the clinical gap of dual anti drugs in the field of lung cancer; The innovative drugs "Beveramide Citrate Injection" and "Naltrexone Hydrochloride Implant" have been approved for market by the National Medical Products Administration... In 2024, a series of "Guangdong made Good Medicines" have been launched successively, not only showcasing the vigorous vitality of Guangdong's biopharmaceutical industry, but also demonstrating its strong innovation power.

In the past year, the Guangdong Provincial Drug Administration (hereinafter referred to as the "Provincial Drug Administration") has closely focused on the deployment requirements of the Provincial Party Committee, Provincial Government, and National Drug Administration, adhered to the overall goal of "leading the way", focused on preventing and resolving major risks, continuously deepened drug regulatory reform and innovation, and the overall drug safety situation in the province has remained stable. The pace of high-quality industrial development has continued to accelerate, and various work has continuously achieved new results.

Looking ahead to 2025, the Provincial Medical Products Administration will focus on a series of reform deployments in the pharmaceutical field, continuously strengthen the responsibility system, deepen the reform and innovation of drug regulation, continuously strengthen the construction of drug regulation capacity, accelerate the pace of drug regulation reform and innovation, and strive to promote the modernization of drug regulation in Guangdong.

Build a strong safety line for people's health

In 2024, in the journey of ensuring drug safety and helping to build a higher level of safe Guangdong, the Provincial Medical Products Administration will continue to strengthen the safety defense line for people's health with firm determination and effective measures——

In terms of improving the drug safety responsibility system, the Provincial Medical Products Administration has promoted the inclusion of drug safety assessment in the comprehensive assessment of market supervision throughout the province. Relying on the Office of the Provincial Food and Drug Safety Commission, we will further establish an integrated drug safety discussion and coordination mechanism with three-level linkage and departmental collaboration. In conjunction with the Provincial Administration for Market Regulation, we will issue the "Opinions on Strengthening Cross regional and Cross level Drug Supervision and Coordination Implementation", deploy and carry out the "three major actions" of strengthening the quality of drugs, strict management and improvement of medical devices, and strengthening the quality of cosmetics enterprises, and build a "one game" pattern of drug collaborative supervision with local leadership, drug supervision departments as the main drivers, and other departments performing their respective duties.

The continuous promotion of drug safety consolidation and improvement actions has achieved significant results. As of November 2024, a total of 6540 cases of "two products and one equipment" have been investigated and handled in the province, a year-on-year increase of 2.5%. The value of the involved goods was 311 million yuan, a year-on-year increase of 87.5%. The fine was 205 million yuan, a year-on-year increase of 19.7%, 15 licenses were revoked, and 38 people were punished each time. In addition, the Provincial Drug Administration has successfully investigated and dealt with multiple influential major cases nationwide, maintaining a high-pressure crackdown on drug crimes and effectively maintaining the order of the drug market.

The intensity of drug safety supervision and sampling continues to increase. In 2024, Guangdong drug supervision will conduct random inspections on over 15000 batches, including over 9000 batches in the retail and medical institutions. The coverage rate of national centralized procurement for selected varieties produced within the province will reach 100%, and strict implementation of verification and disposal of unqualified drugs will be carried out; 1795 batches of medical devices and 3952 batches of cosmetics were sampled, and the qualification rates of each category were maintained at a high level. Through strict sampling procedures, the safety of medication, equipment, and makeup for the public has been effectively ensured.

Establishing and improving the risk consultation mechanism is also a crucial aspect. The Provincial Medical Products Administration regularly conducts risk consultations and drug safety situation analysis, establishes a "list system" and "cancellation system" for risk hazards, and ensures closed-loop risk management. In 2024, a total of 23 drug safety risk conferences were held to properly handle prominent risks such as the return of drugs from medical insurance, playing an important role in maintaining social stability and resolving potential drug safety crises at an early stage.

The construction of the pharmaceutical industry highland in the Greater Bay Area continues to accelerate

The pharmaceutical industry in the Greater Bay Area is rapidly developing and becoming an important force in promoting regional economic growth and improving people's well-being. On this vibrant land, a series of measures are helping to accelerate the construction of the pharmaceutical industry highland in the Greater Bay Area.

Regulatory innovation lays a solid foundation for the introduction of drugs and equipment.

The Provincial Medical Products Administration actively cooperates with the Provincial People's Congress to formulate and issue the "Regulations on the Administration of Imported Drugs and Medical Devices from Hong Kong and Macao in Nine Mainland Cities of the Guangdong Hong Kong Macao Greater Bay Area", providing solid guarantees for the implementation of the "Hong Kong Macao Drug and Medical Device Connect" policy through legislation. At present, the "Hong Kong Macau Medical Device Connect" has announced 45 designated medical institutions, achieving full coverage in 9 cities in the Greater Bay Area, introducing 92 varieties, and benefiting nearly 10000 residents in the area. Not only does it provide patients with more treatment options, but it also promotes deep cooperation and exchanges between Hong Kong, Macao, and mainland China in the field of medicine.

Reform of review and approval to accelerate the implementation of pharmaceutical innovation achievements.

In the reform of major drug and equipment review and approval in the country, Guangdong actively promotes linkage and carries out pilot projects for supplementary applications for major drug changes. It undertakes pre service services such as on-site inspection, registration inspection, and filing review, greatly accelerating the process of drug post market change review and approval.

At the same time, the Provincial Food and Drug Administration efficiently undertook the delegated approval matters entrusted by the State Food and Drug Administration, and simplified the registration of traditional traditional Chinese patent medicines and simple preparations for external use that has been listed in Hong Kong and Macao and listed in the mainland, with 15 varieties approved.

The optimization of the review and approval process has achieved significant results, with a 50% speed increase in the registration review of Class II medical device products, an average registration cycle of 4.5 months, and a speed increase of over 60% in the one-time import review and approval of drugs, reducing the statutory 30 working days to 10 working days... This has enabled innovative drugs and devices to enter the market faster and benefit patients.

Promote industrial development and assist the high-quality takeoff of the pharmaceutical industry.

Last year, Guangdong issued the "Action Plan for Further Promoting the High Quality Development of Guangdong's Biopharmaceutical Industry". The Provincial Medical Products Administration focused on the key areas of review and approval reform, capacity and service platform construction, and major strategic reform deployment, providing comprehensive support for the high-quality development of the pharmaceutical industry. At present, a total of 7 Class 1 innovative drugs, 2 new traditional Chinese medicine drugs, 10 Class 2 improved innovative drugs, and 14 innovative devices have been approved in the province, ranking among the top in the country.

Strengthening the construction of drug regulatory capacity from multiple dimensions

Over the past year, Guangdong has focused on key issues in drug regulation, adhered to problem and goal orientation, conducted 11 special investigations, analyzed prominent problems in improving regulatory, safety, and development institutional mechanisms, proposed reform measures, and provided decision-making basis for subsequent work.

In terms of implementing reform tasks, we will vigorously implement the 28 reform measures of the Provincial Drug Administration in implementing the decisions of the Third Plenary Session of the 20th Central Committee of the Communist Party of China, clarify responsibilities, strengthen supervision, promote major reforms, resolve institutional and structural contradictions, and lay the foundation for modernization of supervision.

In addition, Guangdong is focusing on supporting and addressing weaknesses, and strengthening the construction of drug regulatory capabilities from multiple dimensions.

In terms of intelligent supervision, the Provincial Medical Products Administration undertakes the demonstration project of cross provincial collaborative supervision of drug production commissioned by the National Medical Products Administration, coordinates the completion of shared and collaborative construction in five provinces, and contributes to the "Guangdong wisdom"; Jointly promote the integration of market supervision and regulation in Guangdong Province, achieve the linkage of "two products, one equipment" four level cross level supervision, and create an efficient integrated supervision model.

Last year, significant achievements were made in the construction of Guangdong's drug regulatory technical support capacity: 3551 drugs and 213 medical device standard inspection expansion projects were completed, the coverage rate of routine inspection parameters for drugs and cosmetics reached 100%, and the province achieved full coverage of batch issuance of blood products and vaccine varieties. The medical device inspection capacity ranked among the top in the country.

In terms of strengthening team building, Guangdong has expanded its three teams of drug non clinical trial inspectors, drug device clinical trial inspectors, and drug vigilance inspectors. The province now has 3325 professional drug inspectors, covering all aspects of the "two products and one device" category.