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As China's drug regulatory reform has entered a new stage, in recent years, the State Drug Administration has issued a series of policies and regulations in deepening the reform of drug review and approval, institutionalizing, long-term and standardizing
the reform measures.
Recently, at the "14th China International Drug Information Conference and 2022 DIA China Annual Conference", Yang Sheng, Director of the Department of Drug Registration Administration of the State Medical Products Administration, delivered a keynote speech entitled "Deepening the Reform of the Drug Review and Approval System and Promoting the High-quality Development of the Pharmaceutical Industry", and conducted in-depth discussions
on cooperation and innovation, new measures for the reform of drug regulatory policies, and the globalization development path of China's drug research and development.
Take multiple measures to deepen drug regulatory reform
Nurturing new opportunities in crises and opening up new opportunities
in changing situations.
The newly revised Measures for the Administration of Drug Registration (hereinafter referred to as the "Measures") has been officially implemented since July 1, 2020, enriching the content of encouraging drug development and innovation, and laying a solid foundation
for the construction of a drug registration management system in the new era.
Yang Sheng said that in the field of drug registration, with the "Measures for the Administration of Drug Registration" as the core, the drug regulatory authorities have successively issued more than 60 supporting documents and more than 400 technical guiding principles, which together constitute the institutional framework
of the "four beams and eight pillars" of drug registration management.
This year, the revision of the Regulations for the Implementation of the Drug Administration Law is progressing in an orderly manner as planned, and the top-level design
of the drug regulatory system will continue to be strengthened.
As a programmatic document for drug standard management, the Measures for the Administration of Drug Standards are of great
significance for comprehensively strengthening the capacity building of drug supervision, further standardizing the management of drug standards, promoting the upgrading of the pharmaceutical industry in the new era, and developing with high quality.
The Measures for the Administration of Drug Standards are being publicly solicited from the industry, widely listened to, revised and improved and released
to the public according to the procedures.
With the increasing globalization of new drug R&D and innovation, the number of "global new" drugs such as new mechanisms and new targets has gradually increased, and the challenges and pressures of innovative products on the review capacity have become increasingly prominent
.
In 2022, the four "fast tracks" of breakthrough therapy drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures will further accelerate drug R&D and marketing
.
It is worth mentioning that this year, the State Food and Drug Administration has begun to start the revision of the review and approval procedures for conditional approval of marketing applications
.
Yang Sheng believes that the conditional review channel should be strictly standardized, strictly prevent generalization, and use good policies on products that are urgently needed clinically
.
In terms of strengthening the construction of drug registration management informatization, implement the reform requirements of "decentralization, management and service", optimize the business environment, further stimulate the development vitality of market entities, improve the efficiency of drug review and approval, and provide enterprises with more efficient and convenient government services
。 Yang Sheng said that the drug registration management informatization construction plan is divided into three steps: the first step is to issue electronic registration certificates for drugs, and since November 1, 2022, all drug registration certificates issued by all state bureaus have been implemented electronically; In the second step, from January 1, 2023, all newly received applications for registration at the national Office level, as well as additional information during the evaluation process, will be adjusted to be submitted in electronic form; The third step is to strengthen the construction of internal interconnection, from technical review to verification and inspection, to generic name approval and administrative approval, all drug registration management work will be paperless office and information management
.
In addition, the new measures being carried out by the NMPA include: strengthening international exchanges and cooperation, actively participating in ICH-related work, and actively transforming ICH-related guidelines; Improve the management policy for the re-registration of chemical APIs; Study the opinions on reforming the management of radiopharmaceutical review and approval; Improve and refine the implementation standards of the Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (for Trial Implementation); Strengthen the management of GLP institutions, optimize GLP certification procedures and requirements, etc
.
In the future, the NMPA will focus on the actual needs of scientific supervision of drugs, strive to promote regulatory scientific research and innovation leadership, continuously form high-level new standards, new tools and new methods, and improve the ability and level
of scientific supervision.
In the evaluation of China's vaccine regulatory system by the World Health Organization in 2022, China has been highly praised
by the World Health Organization's expert evaluation team in the fields of marketing authorization and drug clinical trial supervision.
Yang Sheng believes that the State Food and Drug Administration actively participates in international cooperation and exchanges, promotes the coordination and integration of regulatory policies with international standards, realizes the harmonization of China's drug review and approval standards with the standards of regulatory developed countries, improves the scientific and reasonable recognition of China's regulatory processes and regulatory requirements by international organizations such as the World Health Organization, and helps China's new drugs and good drugs go abroad
.
Yang Sheng said that China's continuous promotion of the coordination and transformation of ICH has laid a foundation
for China's standards and norms for new drug research and development and clinical trial research to be in line with international standards.
In 2022, the NMPA will continue to make every effort to review and approve drugs and vaccines under the normalization of epidemic prevention and control
.
In recent years, the State Food and Drug Administration has taken a series of measures to accelerate the marketing and registration of drugs, and a number of new and good drugs have been accelerated to further meet the public's health drug needs
.
Yang Sheng pointed out that in recent years, the number of IND acceptances of innovative drugs has increased year by year, and the number of innovative drugs on the market has continued to increase
.
Imported drugs have fully enjoyed the reform dividend, and the number of applications and approvals for registration of imported drugs has increased
year by year.
Overseas new drug clinical trial applications have increased significantly, and overseas new drug marketing applications have increased
steadily.
With the continuous deepening of the drug review and approval system, domestic pharmaceutical innovation has shown a good situation
of vigorous development.
Adhering to the people-centered orientation of high-quality and high-level pharmaceutical innovation and R&D, the NMPA will continue to improve the drug registration management regulations, continue to promote the revision of the implementation regulations, and continue to improve the supporting documents
of the registration management measures.
Yang Sheng said that to continue to optimize the chain of review and approval, strengthen the connection between acceptance of review and approval, inspection and verification, the State Food and Drug Administration will continue to strengthen the construction of two sub-centers, gradually undertake more tasks, and serve major regional development strategies
.
At the same time, the State Food and Drug Administration will further strengthen international exchanges and cooperation and promote the international exchange
of drug research and development in China.
In the global R&D and innovation link, contribute to China's regulatory strategy and contribute more Chinese new drugs
.
Talking about how the reform of the national drug regulatory policy promotes the research and development of new drug innovation and original new drugs in China, Yang Sheng believes that all pharmaceutical innovation should closely focus on patient-centered, such as children's drugs, elderly drugs, and rare disease drugs
.
Through the guidance of policies, through the linkage of medical treatment, medical insurance, and medicine, and the guidance of the three doctors, we should focus more on the original innovation and more on the innovation with better efficacy than the existing products
.
