1.
Q: Please ask the teachers, can we handle one approval for two specifications of drugs for one import batch?
A: Two specifications require 2 batches
2.
Q: How long is the registration site inspection?
A：
3.
Q: Teachers, if the new class 1 drug is increased during clinical trials, do I need to resubmit the IND application?
A: For ordinary oral preparations produced by conventional prescription processes in the early clinical stage, the new specifications designed according to the proportion of changes in the original specifications and prescriptions, such as no obvious changes in the performance, safety-related indicators and stability of the preparation, can be regarded as general changes, otherwise they should be regarded as major changes; but for special preparations such as liposomes, aerosols, transdermal patches, and sustained release preparations, the impact of the specification changes on the preparations is higher and should generally be regarded as major changes.
Q: Is the general change reflected in the annual report?
A: Yes, what a dosage form
Q: Tablets thank you~
4.
Q: Hello everyone, please ask you a question about the USP dissolution standard In the monograph, NLT Q in XXmin is written, and the actual judgment criterion is based on 711, that is, S1 single pieces must not be less than Q+5. Why not write the final value of Q+5 directly in the monograph?
A: It is based on q, and there are three criteria for judging
Q: You have an epiphany when you explain it
5.
Q: Hello teachers, I would like to ask a question, for the new adaptability, applied for drug registration, so after getting the registration certificate of the National Bureau, how long does the enterprise need to switch the packaging materials? Does this regulation have a time limit? What is the general corporate approach? Thank you!
A: 6 months, look at the latest change guidelines and change declaration information guidelines, there are specific requirements. The general operation is to control the number of packaging materials in the old version, do not do too much, and use the new version as soon as possible after the change is completed
6.
Q: Please advise, if you use a newly registered company name to apply for an IND, the CDE applicant window of the newly registered company has a main account and a sub-account, so if you need to upload electronic information in the future, can the sub-account receive information?
A: Add this product to the sub-account
7.
Q: Please advise everyone, last week to listen to the registration verification of the interim measures, is it from January 1, 2022 to follow the risk, before the inspection must be checked ah ~ ~
A: Before, it was basically based on risk
8.
Q: Teachers, what does dynamic production refer to?
A1: We are referring to the case of conventional production, if not required, some places will stop production during inspection
A2: Dynamic production is the time of registration verification, in accordance with the declared process site production.
9.
Q: Please advise you, does the need to re-evaluate the consistency of the domestic API supplier A?
A1: In accordance with the requirements for the change of listed chemicals, if the registered status of the changed API is A, it will be declared according to the medium change
10.
Q: Please ask the teachers a question, we have a listed preparation to add a supplier of APIs, the current status of the API is I, can we buy it now to do a good job of process verification and stability inspection, wait until they transfer A and then submit the research data to the provincial bureau for the record? Or do you have to wait until their state changes to A before you can start doing supply enhancement studies?
A1: The risk you need to take in advance is that during this period, the batch of APIs you bought did not change from when it was finally converted to A.
Disclaimer: All Q&A is from the Registration Circle Community and is for reference only. If the answer is inappropriate, everyone is welcome to actively correct it.