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Compared with the ups and downs of the general environment, the drug regulatory policies in 2022 are generally stable
.
From the perspective of guiding principles, regulators pay more and more attention to the benefits of clinical research patients, encourage the research and development of new drugs for special groups, and track and guide the development of new pharmaceutical technologies, among which the concept of focusing on clinical needs is constantly emphasized
.
Last year, the Center for Drug Evaluation (CDE) of the State Medical Products Administration officially issued a total of 60 guiding principles and 73 draft guiding principles
.
Compared with 2021, the number of guiding principles issued throughout the year decreased significantly, mainly due to the significant decline in the number of guiding principles related to generic drugs and consistency evaluation, while the number and proportion of guiding principles related to new drug research and development continued to show an upward trend
.
This article divides the Guiding Principles into nine categories according to their focus, and the number and changes of the different categories are shown
in the following chart.
CDE guidelines focus on distribution (Quantitative statistics will be added to the 2022 official release guidelines and draft for comments)
CDE guidelines focus on distribution (Quantitative statistics will be added to the 2022 official release guidelines and draft for comments)Promote patients to become active participants in new drug development
Promote patients to become active participants in new drug developmentThe most significant increase in the number of guidelines issued in 2022 related to clinical research compared to the previous year, and in this part of the guidelines, "patient" is a high-frequency word
.
These include the Guiding Principles for the Application of Patient-Reported Outcomes in Drug Clinical R&D (Trial), the General Considerations for Organizing Patients to Participate in Drug R&D (Trial), the Patient-Centered Clinical Trial Benefits - Technical Guidelines for Risk Assessment (Draft for Comments), the Technical Guidelines for Patient-Centered Clinical Trial Design (Draft for Comments), and the Technical Guidelines for Patient-Centered Clinical Trial Implementation (Draft for Comments
).
These guidelines all mention that the experience, needs, perspectives, preferences, etc.
of the patient side (including the patient's family, guardians, caregivers, and patient organizations) are considered into the scope of new drug development goals and clinical trial data collection, and the guidelines provide practical methods
for sponsors to obtain corresponding information.
As early as 2021, the "Guidelines for Clinical R&D of Clinical Value-oriented Antitumor Drugs" began to mention that the research and development of new drugs should be patient-centric, pay attention to the clinical value of products, and provide patients with better treatment options
.
It's just that at that time, the guiding principle was more interpreted by the industry as a response to the research and development of new drugs with the same target in the field of
tumors.
Looking back after a year, it is more like a prelude to the implementation of the "patient-centered" new drug research and development concept, and the release of more relevant guidelines and consultation drafts in 2022 is a further refinement
of the "patient-centered" drug development concept in practice.
In recent years, due to technological advances and the coronavirus pandemic, decentralized clinical trial methods have been adopted in clinical studies of more and more products, which itself is a move towards patient-centered research, and wearables used in research have begun to be used more to collect patient experience information
.
Some insiders mentioned that, for example, clinical studies of atopic dermatitis products will have subjects wear sleep monitoring bracelets to collect the impact
of treatment products on the inhibition of nighttime itching and the improvement of patients' sleep.
Based on industry trends, the new guidelines reflect the increasing importance of regulatory authorities on patients' participation in new drug research and development, emphasizing from the regulatory level that new drug research and development should transform patients from passive users of products to active participants, and recognize the positive role
of patients in new drug research and development.
The guiding principles clarify the scope of
compliance for R&D companies to communicate with patients and collect patient data during the research process.
Previously, some domestic companies had learned about patient distribution and other information in advance in order to make subject recruitment smoother before starting the research center, but they were worried about the compliance risks
of doing so.
The "Guidelines for General Considerations for Organizing Patients to Participate in Drug R&D (Trial)" clarifies the compliance of this practice, that is, if necessary, the applicant can organize the collection of patient opinions that have not participated in clinical trials for refining and optimizing clinical trial protocols, including analyzing problems related to recruitment difficulties or unanticipated problems before clinical trials are
conducted.
At the same time, the guiding principles also suggest that regulatory agencies may have next steps, especially with the release of the "Guidelines for the Application of Patient-Reported Outcomes in Clinical R&D of Drugs (Trial)" and "Patient-Centered Clinical Trial Benefits - Technical Guidelines for Risk Assessment (Draft for Comments)", it is speculated that in addition to focusing on the objective indicators of disease improvement of therapeutic products, the future review and approval of new drugs may also pay more attention to subjective indicators such as patients' experience and quality of life improvement after medication, and R&D enterprises may need to lay out in advance
。
Provide convenient ways for the research and development of new drugs for special populations
Provide convenient ways for the research and development of new drugs for special populationsIn addition to the "patient-centered" philosophy, the guidelines issued in 2022 signal that regulators continue to focus on and address access to medication for two specific groups: children and rare patients
.
The corresponding number of guidelines issued also continued to increase
compared to 2021.
In terms of children's drugs, a total of 2 formal guidelines and 5 draft for comments were issued in 2022, paying all-round attention to
the problems faced by the research and development of children's drugs.
This includes providing technical guidance for the research and development of new drugs for pediatric diseases with urgent clinical needs, proposing specific methods for developing children's drugs with reference to adult patient research data, and clarifying the precautions
for children's drug research and development according to the psychophysiological characteristics of children.
Most of these guidelines aim to lower the barrier to participation
for child drug developers.
It is worth mentioning that the "Working Procedures for the Application and Management of Children's Drug Communication and Exchange (Draft for Comments)" issued in 2022 indicates that the regulatory authorities will also provide special support
for children's drugs in terms of drug review and approval.
The Draft mentions that for Class II meetings on children's drugs that fall under four types of communication and exchange situations, enterprises will apply to adjust the type of meetings, and eligible Class II meetings will be adjusted to Class I meetings, and the time limit for convening will be shortened from 60 days to 30
Day
.
Class II meetings are mostly held at key nodes of new drug R&D and marketing, and shortening the communication time will effectively accelerate the process of
children's drug innovation and R&D.
So far, the National Health Commission has issued three batches of the List of Children's Drugs Encouraged to be Declared by R&D, and the above guidelines have been issued to strongly echo
this.
In 2022, the research and development of rare disease drugs ushered in the release of key guiding principles "Technical Guidelines for Clinical R&D of Rare Disease Drugs" and "Guidelines for Statistics of Clinical Research of Rare Disease Drugs (Trial)", both of which were published at the end of 2021 and officially announced
in early and mid-2022.
Due to the extremely low incidence and prevalence of rare diseases, the variety of disease types, complex phenotypes, and diversified clinical manifestations, clinicians' understanding of diseases is generally insufficient
.
Carrying out the clinical development of new drugs for rare diseases faces many difficulties
in addition to the common problems of clinical research.
The guidelines suggest that more flexible designs can be adopted to leverage limited patient data to support regulatory decision-making
, based on ensuring rigorous science.
The guiding principles address this point, addressing key challenges
in the clinical development of rare disease drugs.
Sinopharm International imported mitotan
for the first rare disease drug for adrenal cortex carcinoma.
(Photo courtesy of Sinopharm China National Pharmaceutical Foreign Trade Co.
, Ltd.
)
Children and rare patients are often overlooked in
the development of new drugs.
Many people may have encountered the embarrassment that fever-reducing drugs could not be bought last month, and children's antipyretic drugs such as ibuprofen suspension were even more scarce
.
All parties have been calling for accelerating the research and development of pediatric and rare disease drugs for a long time
.
With the attention of regulators and the encouragement of new policies, can such embarrassment be successfully resolved? Once regarded by enterprises as the research and development of children's drugs and rare disease drugs with high risks and low profits, will they become the sweet potato of enterprises due to policy adjustments? At present, the market reaction is still waiting for time to test, and according to the current trend, it is expected that the policy will continue to exert force
in the future.
Fast tracking guides the development of new therapeutic products
Fast tracking guides the development of new therapeutic productsThe 2022 Guiding Principles also reflect the regulator's close tracking of the development of new therapeutics and their openness to new and more innovative products
.
The difference between drug research and development in recent years and the past is clearly reflected in the rapid emergence
of new therapeutic methods.
Cell therapy, gene editing, RNA interference, tumor vaccines, oncolytic viruses, bispecific antibodies, antibody conjugates (ADCs) and other therapies have emerged
one after another.
Chinese R&D companies are no longer just followers of new drug research and development, and many Chinese companies have been able to keep pace with global technology leaders in the design and development of new therapeutic products that have become hot
spots.
According to the statistics of Southwest Securities, as of the end of 2021, the global total
400 ADC drugs are under development, including 144 ADC drugs under development by Chinese enterprises
, the second
largest in the world.
In terms of product launch, only 8 bispecific antibody drugs have been approved for marketing in the world, and in 2022, China will also usher in the first self-developed bispecific antibody marketing approval
.
In the face of the rapid momentum of research and development, from the perspective of the issuance of guiding principles, regulators have chosen to take the initiative, intending to let the policy run ahead of the enterprise
.
Guidelines and exposure drafts related to novel therapeutic products have exceeded double digits for two consecutive years, and the number of releases reached 11 in 2022
.
Among them, the "Technical Guidelines for Clinical R&D of Bispecific Antibody Antitumor Drugs", "Technical Guidelines for Clinical R&D of Anti-tumor Antibody Conjugate Drugs (Draft for Comments)" and "Technical Guidelines for Clinical Trials of Oncology Therapeutic Vaccines (Draft for Comments)" are the first clinical development guidelines in the field of corresponding product development, and most of the product research and development in these fields is still in the early stage
.
In writing such guidelines, regulators have taken an attitude
of joint exploration with the industry.
For example, in the "Technical Guidelines for Clinical R&D of Anti-tumor Antibody Conjugate Drugs (Draft for Comments)", it is mentioned at a large length that ADC products should carry out extensive exploratory research in the early stage of research and development, and analyze the limited failures or successful cases that ADCs have produced, reminding developers of the precautions for early stage research, but it does not require enterprises to follow specific operation routes
in research and development.
In addition, other newly issued guidelines in 2022 also support the development of new therapeutic products
.
For example, the "Technical Guidelines for Applicability of Single-arm Clinical Trials to Support the Marketing Application of Antitumor Drugs (Draft for Comments)" provides guidance and basis for accelerating the approval of breakthrough drug research and development, and the guiding principles propose that if the exploratory research data of the early experimental drug indicates outstanding clinical efficacy, conditional approval
can be given based on the results of single-arm research.
The development of new therapeutic products is usually aimed at breaking through existing therapies, such as CAR-T cell therapy, which can achieve complete remission
of a large proportion of treated patients.
Industry insiders mentioned in the interview that these guidelines show that regulators are guiding the development of new therapeutic products, from focusing on speed to focusing on quality, and the guiding principles help new technologies smoothly through the early stages of growth, rather than wild growth
.
Extensive exploratory research can help developers learn more about product risks and unknown information in the early stage, and will also pay more attention to clinical needs in research and exploration, instead of clustering in the development
of individual targets and varieties.
Looking at the guidelines issued in 2022, on the whole, patient needs will be a more inescapable topic in the future of new drug development, and regulators will pay more attention
to this in the future.
