Review of major pharmaceutical policies in 2021

2021 is the first year of the "14th Five-Year Plan".

Figure 1.

Source: Collation of public information

From the perspective of the policy issuing department, the State Food and Drug Administration (including the Drug Evaluation Center) issued the largest number of policies, followed by the Health and Health Commission and the Medical Insurance Bureau

Figure 2.

Source: Collation of public information

I.

On March 12, the "14th Five-Year Plan for National Economic and Social Development of the People's Republic of China and the Outline of the Vision for 2035" was authoritatively released, which clarified the country's policy requirements for the "14th Five-Year Plan" period and the economic and social development in the next 15 years.

Table 1.

Source: Collation of public information

2.

In terms of drug registration: On January 13, the State Food and Drug Administration issued the "Administrative Measures for Post-marketing Changes of Drugs (Trial)" to standardize the post-marketing changes of drugs by drug marketing authorization holders.

Drug research and development: On November 19, the State Food and Drug Administration issued the "Guidelines for Clinical Research and Development of Anti-tumor Drugs Oriented to Clinical Value", which established the technical principles of clinical value-oriented drug research and development in the field of anti-tumor drugs , establishing a patient-centered research and development concept, which not only guides the research and development of anti-tumor drugs, but also has a profound impact on the establishment of all innovative drugs in the future.

In terms of drug supply: On January 28, the General Office of the State Council issued the "Opinions on Encouraging the Normalization of the Centralized and Volume-Based Procurement of Medicines", proposing specific measures to promote the normalized and institutionalized development of the centralized and volume-based procurement of medicines; November 4 On July 1, the State Food and Drug Administration issued the "Notice on Using the Information Collection Template for Production Supply and Discontinuation Reports of Shortaged Drugs"

In terms of drug use: On September 3, the National Health and Health Commission issued the "Notice on Printing and Distributing the Work Procedures for the Adjustment of the National Key Monitoring and Rational Drug Catalogue".

Others: This year, China's first patent linkage system, "Implementation Measures for the Early Resolution Mechanism of Drug Disputes (Trial)" was issued to encourage innovation of generic drugs while protecting drug patents from infringement; The pilot work of formula granules was completed at the beginning of the year, and the formal record management was carried out; the "Notice on Several Policies and Measures to Accelerate the Development and Development of Traditional Chinese Medicine Characteristics" was issued, and 28 measures were put forward from the aspects of talents, industry, capital, development environment, etc.

Table 2.

Source: Compiled by Aleigh

3.

On August 13, the State Council issued the "Regulations for the Management of Long-Term Prescriptions (Trial)" to standardize the management of long-term prescriptions and meet the long-term medication needs of patients with chronic diseases; Plan", the plan proposes to explore the formation of replicable and scalable medical service price reform experience through 3 to 5 years of pilot projects

Table 3.
Summary of key medical policies in 2021

Source: Compiled by Aleigh

4.
Medical insurance policies

On December 3, the National Medical Insurance Bureau issued the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue (2021)".
This catalogue was adjusted directly to 7 (all Western medicines) and negotiated 67 (including 3 traditional Chinese medicines), call out 11
.
Compared with the 20th edition of the medical insurance catalog, the number of transfers this time has decreased, but the proportion of negotiated inclusion has increased, from 80.
67% in the 20th edition to 90.
54%, an increase of nearly 10%
.
It can be seen that negotiated inclusion has become the mainstream way to include medical insurance
.
In addition to the adjustment of the medical insurance catalogue, which is the most concerned, significant progress has been made in medical insurance payment standards, reform of medical insurance payment methods, employee medical insurance outpatient financial security, and medical insurance information standardization
.

Table 4.
Summary of key medical insurance policies in 2021

Source: Compiled by Aleigh

5.
Supervision

On April 27, the National Health and Medical Commission issued the "Key Points of Correcting Unhealthy Practices in the Field of Pharmaceutical Purchase and Sales and Medical Services in 2021"
.
It mainly mentioned many aspects such as cracking down on the illegal use of medical insurance funds, cracking down on illegal acts in key areas, strengthening industry supervision and internal governance
.
On May 10, the General Office of the State Council issued the "Implementation Opinions on Comprehensively Strengthening Drug Regulatory Capacity Building"
.
It is proposed to improve drug review capabilities, improve emergency management, implement information-based follow-up of drugs, and strengthen law enforcement
.
In addition, relevant provisions have been made on deepening the reform of "delegating power, delegating power, regulating services", drug price and credit supervision of procurement, bidding regulations, etc.
, and the supervision of medical and health care has been strengthened as a whole
.

Table 5.
Summary of key regulatory policies in 2021

Source: Compiled by Aleigh

2021 has passed, and the pharmaceutical industry has been forging ahead under repeated epidemics.
Entering 2022, the main theme of the pharmaceutical field is high-quality development, with the development trend of encouraging innovation, emphasizing credit, and focusing on cost control.
We look forward to more heavyweights The release of the policy has led the pharmaceutical industry to a new journey
.