Before the sponsor submits the IND application, the sponsor can request a Pre-IND meeting FDA with the review leader. The main purpose of the meeting is to evaluate and reach consensus on the design of animal research needed to support the first human trial, which can speed up the development of new drugs, effectively shorten the time for new drug approval, and save development costs.
The research and development of new drugs is a systematic and complex science, including drug discovery, drug preclinical research, clinical research, marketing approval, and post-marketing research and evaluation stages. With the deepening of research and development at each stage of new drug research and development, people’s understanding and understanding of new drugs gradually goes from shallow to deep. The main link of the new drug IND application is that the subjective department of the drug scientifically evaluates the safety, effectiveness, and quality controllability of the new drug based on the research data and information submitted by the applicant, so as to determine its next step of research or approval for marketing. This determines that the IND application and approval can only be post-evaluation, and reviewers can only understand and evaluate new drugs through the materials submitted by the applicant. The pre-IND submission meeting has played a pivotal role in shortening the time for new drug development and approval and promoting early listing. Medicilon’s clinical registration (IND) application service platform has an in-depth understanding of the regulatory and policy environment of China and the United States and its technical requirements for chemical drugs. It can provide domestic customers with CFDA IND application and USFDA IND/ANDA application services; it can provide foreign customers Provide CFDA IND/ANDA declaration service
(1) Whether the drug has a certain degree of safety that can be used in the human body. Such as the safety of excipients;
(2) Whether the chemical verification test or animal model is fully effective for the target disease is worthy of commercial development investment. When the product is confirmed as a viable drug candidate, the sponsor will focus on the research to prove the effectiveness of the drug and collect safety data and dosage information, which can indicate that the drug is used in a limited, early stage The human body clinical research will not cause unreasonable risks to the human body.
(1) At the Pre-IND meeting, there may be an opportunity to discuss the scope and design of phase 1 clinical trials, such as sample size, study design, clinical endpoints, and statistics;
(2) The plan of drug research in pediatric population, the format of data and the best way of presentation in the IND application materials;
(3) The meeting can also discuss whether the existing CMC information is sufficient to support the clinical trial plan (the production process and control process of drug materials and drugs, drug trials and specifications, the chemical compatibility of excipients, and the planned clinical trials to ensure drugs Necessary data for stability), and different regulatory plans (breakthrough therapy, fast track application, orphan drug application).
Moreover, there is no charge for holding a Pre-IND meeting, and the sponsor can request the FDA to give feedback on the drug development plan in the form of written feedback, reducing travel expenses and other expenses. These advantages of Pre-IND conferences all attract sponsors to apply for pre-IND conferences that are beneficial to them. FDA encourages but does not force sponsors to hold Pre-IND meetings. Although the time from submitting a meeting application to receiving feedback information may be as long as several months, in the long run, this measure can speed up the market of drugs and help formulate drug research and development strategies.
Not all sponsors who submit an IND need to hold a Pre-IND meeting. Simpler clinical trials do not need to hold a Pre-IND meeting. However, a Pre-IND meeting is required when the drug being developed is in the following situations:
(1) New chemical entity drugs;
(2) Class 1 drugs;
(3) New mechanism of action or applicable symptoms;
(4) Existing guiding principles are covered situations;
(5) Fast-track approved drugs and orphan drugs;
(6) Regulatory mechanism, such as 505(b)(2);
(7) Problematic pharmacological and toxicological signals;
(8) Serious or life-threatening target diseases;
(9) The new sponsor or sponsor is unfamiliar with the field of drug development;
(10) Major sponsor issues.
In order to convene a Pre-IND meeting, the initiator must formulate and submit a written request to the FDA. The written request should include the product name, application number, chemical name and structure of the drug, expected indications or product development environment, and the type of meeting requested (I.e. Pre-IND meeting), brief statement of the purpose and objectives of the meeting, meeting agenda, list of questions classified by subject, list of participants, appropriate time for the meeting, method of holding the meeting, summary documents) date.
The most important content in the written request of the meeting is a list of questions classified according to disciplines. The sponsor should strictly ask each question and explain the background and purpose of each question.
The FDA requires sponsors to electronically submit the conference information package in the format of a common technical document (e-CTD), which includes: a detailed description of the drug and its characteristics, recommended clinical trials, API, raw materials, ingredients, grades and release standards, etc. Production process review including description, flow chart and pollutant control, pre-clinical data review, human application experience summary, etc.
After submitting a written request, FDA will designate a regulatory plan manager for the sponsor to be responsible for the negotiation and communication between the sponsor and FDA; FDA will send a notice of consent or rejection within 21 days after receiving the written request The form responds to the initiator. Generally speaking, the FDA will approve most of the Pre-IND meeting applications, and an IND application can only apply for one Pre-IND meeting.
After passing the Pre-IND meeting application, the sponsor must submit a brief document to the FDA at least one month before the expected meeting date (or the expected date when written feedback is received). The summary file should provide the CMC summary information of the product, any supplementary information required, and add the data list as appropriate to help FDA solve the problems raised by the sponsor or the problems found by the FDA in the process of reviewing the written request submitted by the sponsor.
The FDA recommends that sponsors who have passed the meeting application conduct a rehearsal of the meeting before the meeting. The initiator does not need to give a formal speech at the meeting, but all meeting participants, especially those who will speak at the meeting, must memorize and understand all the information in the profile and the data to be discussed. The sponsor can organize an FDA simulation team and request other team members to play the role of FDA, so that participants can cope with the meeting freely.
About two to three days before the expected meeting, FDA will send a preliminary meeting feedback to the sponsor. After receiving the brief document, FDA will hold an internal meeting to discuss the content of the brief document and find solutions to the problems submitted by the sponsor. And reached a preliminary agreement on the solution, and finally formed a preliminary meeting feedback. If the initial meeting feedback is easy to understand and the sponsor wishes to cancel the meeting, FDA should respect the sponsor’s decision to cancel the meeting, and the initial meeting feedback will be sent to the sponsor as the final meeting application feedback.
The last step is to hold a meeting. First, FDA members introduced and summarized the meeting agenda. After that, the meeting will focus on the issues that the sponsor wants to discuss. Usually, the preliminary meeting feedback is very detailed. The initiator can solve most problems through the preliminary meeting feedback. Therefore, the initiator can use the meeting time to discuss one or two issues that have not yet been resolved. The main points discussed by the FDA include the pharmaceutical information of chemical drugs or biological drugs, pharmacology and toxicology, clinical microbiology, clinical aspects and pediatric research plans, quality of life assessment, etc.
Before the end of the meeting, the FDA, sponsors, and participants should summarize the discussion points, recommendations, decisions, and upcoming actions of the meeting. FDA can ensure the preservation of meeting information for future use by allowing its staff to record in real time and present the records on the projection screen. Within 30 days of the end of the meeting, the FDA will send the official and final minutes of the meeting to the sponsor.
Literature:
[1] FDA’s experience in establishing a meeting system for communicating with applicants has enlightenment on my country’s new drug approval[J].
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