[Xingyan] Review of major pharmaceutical policies in 2021

2021 is the first year of the "14th Five-Year Plan".
Looking back on this year, policies for the pharmaceutical industry were introduced intensively.
More than 500 policies related to the pharmaceutical industry were released at the national level throughout the year, of which there were about 200 key policies, and the number of policies was relatively high.
There was a substantial growth last year, and a number of policies will have a significant impact on the development of the pharmaceutical field in the next few years
.

From the perspective of key policy categories, pharmaceutical policies have been issued the most, accounting for about 58%, mainly involving various policies such as drug registration and approval, APIs, drug patents, pharmacovigilance, and development of traditional Chinese medicine and formula granules; followed by medical policies accounting for about 58%.
18%, including long-term prescription, public hospital reform, hierarchical diagnosis and treatment, medical and health service reform and promotion of Sanming City’s experience in medical reform; medical insurance policies account for about 19%, mainly including medical insurance catalog adjustment and negotiation, DRG/DIP payment methods, urban and rural residents medical insurance etc.

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Figure 1.

The proportion of the classification of pharmaceutical policies in 2021 Source: Collation of public information

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

Figure 2.
Proportion of key policies released by various departments Source: Collation of public information

1: Programmatic policies

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.
The long-term goal of social development points out the key development direction of the pharmaceutical industry in the future
.

It is proposed to comprehensively promote the construction of a healthy China, accelerate the construction of a hierarchical diagnosis and treatment system, and actively develop a medical consortium

"The 14th Five-Year Plan for the National Economic and Social Development of the People's Republic of China and the Outline of the Vision for 2035"

On June 17, the State Council issued the "Notice on Key Tasks for Deepening the Reform of the Medical and Health System in 2021" , proposing to vigorously promote the experience of medical reform in Sanming City; promote the centralized procurement of pharmaceutical consumables; and accelerate the reform of medical care, medical insurance, and pharmaceutical linkages
.

"Notice on the key tasks of deepening the reform of the medical and health system in 2021"

On December 30, the State Food and Drug Administration and other 8 departments jointly issued the "14th Five-Year Plan for National Drug Safety and Promotion of High-quality Development" , clarifying the guiding ideology of drug safety and promoting high-quality development during China's "14th Five-Year Plan" period.
Five general principles and main development goals of "adherence" are put forward, and 10 main tasks are formulated to ensure drug safety during the "14th Five-Year Plan" period, promote high-quality development of drugs, promote the modernization of the drug regulatory system and regulatory capacity, and protect and Promote public health
.

"14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development"

Table 1.
Other series of policies in the 14th Five-Year Plan

Source: Collation of public information

Two: key policies for pharmaceuticals

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.
The normative documents were subsequently issued; the "Guidelines for the Acceptance and Review of Chemical Drug Changes (Trial)", "Guidelines for the Acceptance and Review of Changes in Traditional Chinese Medicines (Trial)" and "Guidelines for the Acceptance and Review of Biological Products Changes (Trial)" were successively issued to standardize the acceptance and review requirements for drug changes in all aspects.
; On December 20th, the "Working Procedures for Drug Registration Verification (Trial)" was released, which put forward clear requirements for drug registration review and application for listing
.

With the start of the drug registration verification and inspection work, the domestic new drug registration approval may be more standardized

For drug registration:

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.
Principles", which mainly focuses on issues related to premarket clinical pharmacology research of innovative drugs
.

In addition, throughout the year, guidelines and technical requirements for multiple types of drugs in various fields such as biosimilars, chemical drugs, improved new drugs, gene therapy, cell therapy, intravenous anesthesia, COVID-19 chemical drugs, and COVID-19 neutralizing antibodies were issued.

For drug research and development:

In terms of drug production: On November 9, the National Development and Reform Commission and the Ministry of Industry and Information Technology issued the "Notice on the Implementation Plan for Promoting the High-Quality Development of the API Industry", making corresponding arrangements for the development and supervision of APIs
.

In the next five years, the API industry will vigorously develop characteristic APIs and innovative APIs, and increase the proportion of new products and high value-added products

For pharmaceutical production:

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 supply:

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".
The key monitoring drug list is facing adjustment and expansion, and the plan is to be adjusted from the previous 20 to 30.
The final list has not yet been announced; on November 15, the National Health and Health Commission publicly solicited opinions on the "Administrative Measures for the National Essential Medicines List (Revised Draft)", and the draft added The list of children's drugs has been established, and drugs that are clearly included in the national key monitoring and rational drug use list are no longer included in the selection scope of the national essential drug list
.

In addition, the National Health and Health Commission issued the "Notice on Standardizing the Comprehensive Evaluation of Drugs" on July 2, and issued the "Notice on Printing and Distributing the Guidelines for the Clinical Application of New Antitumor Drugs (2021 Edition)" on December 27; On November 15, the bureau publicly solicited the "Measures for the Supervision and Administration of Drug Distribution and Use Quality (Draft for Comment)"

Use of medicines:

Others: This year, China's first patent link system, "Implementation Measures for Early Resolution Mechanisms for Drug Disputes (Trial)" was introduced 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.
The development of quality characteristics is escorted; the "Pharmacovigilance Quality Management Practice" is issued to regulate and guide the pharmacovigilance activities of drug marketing authorization holders and drug registration applicants
.

other:

Table 2.
Summary of key pharmaceutical policies in 2021

Source: Compiled by Aleigh

Three: medical policy

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
.

By 2025, the experience of deepening the pilot reform of medical service price reform will be promoted nationwide

On October 14, the National Health Commission and the State Administration of Traditional Chinese Medicine jointly issued the "Promotion Action for High-Quality Development of Public Hospitals (2021-2025)", which clarified 8 specific items for the high-quality development of public hospitals during the "14th Five-Year Plan" period.
action
.

On November 22, the National Health and Medical Commission issued the "Notice on Promoting the Experience of Hierarchical Diagnosis and Treatment and Medical Consortium Construction in Sanming City", proposing the key tasks of promoting the construction of hierarchical diagnosis and treatment and medical consortium.
Improving the hierarchical diagnosis and treatment system plays an important guiding role
.

Table 3.
Summary of key medical policies in 2021

Source: Compiled by Aleigh

Four: medical insurance policy

On December 3, the National Medical Insurance Bureau issued the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2021)".
This list 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.

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

Five: 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
.