Since the release of the chemical registration classification reform work plan (hereinafter referred to as the program) since March 4, it has received much attention from the industry. Various media and industry insiders have interpreted the program in various ways, and many doubts have been raised. On March 16, the Food and Drug Administration officially interpreted the relevant issues of the program on the official website.

First, the background of the program.

On August 9, 2015, the State Council issued the "Opinions on Reforming the Approval System for Drug Medical Device Evaluation and Approval" to clearly adjust the drug registration classification. On November 4, 2015, the 17th meeting of the Standing Committee of the 12th National People's Congress deliberated and passed the “Decision on Authorizing the State Council to Launch the Pilot System of Drug Listed Subjects in Some Places and Related Issues”, agreeing with the State Council Carry out drug product classification reform. In order to implement the above policy requirements and meet the actual work needs, the General Administration of Food and Drug Administration has issued this plan.

Second, the scope of application of the program.

This program has only been adjusted for chemical drug registration classification, and is applicable to newly accepted chemical drug registration applications (including clinical, production, and import registration applications) after the implementation of the program.

3. What is the meaning of the new drug in the new registration classification?

The new drugs refer to drugs that are not listed in China and abroad, and are classified into innovative drugs and improved new drugs.

The new registration category 1 is an innovative drug that emphasizes the inclusion of new, well-defined, pharmacologically active compounds; the newly registered classification 2 is a modified new drug that is optimized on the basis of known active ingredients, emphasizing a clear clinical advantage.

4. What does the innovative drug specifically include?

An innovative drug is a drug that contains a new, well-defined, pharmacologically active compound and has clinical value, and does not include a Class 2.1 drug in a modified new drug.

5. What is the meaning of generic drugs in the new registration classification?

Generic drugs refer to the imitation of drugs that have been listed on the original research drugs. They are divided into two categories. One is the imitation of overseas unlisted original drugs in the territory, and the other is the imitation of the original drugs that have been listed in the territory. The generic drug requirements are consistent with the quality and efficacy of the original drug.

If the original drug of the listed drug cannot be traced or the original drug has been withdrawn, it is recommended not to apply for imitation; if the application for generic drug is insisted, in principle, it cannot be approved by the technical requirements of the generic drug, and relevant research should be carried out in accordance with the requirements of the new drug. .

6. What is the meaning of the fifth category of drugs in the new registration category?

The fifth category of drugs refers to the listing of drugs for overseas listing in China, which are divided into two types: original research drugs and non-original drugs. Corresponds to the category of imported drugs in the original chemical registration classification.

7. What is the new compound preparation containing the unknown active ingredient?

New compound preparations containing new, well-defined, pharmacologically active compounds should be declared in accordance with New Registration Category 1.

8. Does the generic drug require the prescription process, specifications, usage and dosage to be consistent with the original research?

The generic drug requires the same active ingredients, dosage forms, specifications, indications, routes of administration, and usage and dosage as the original drug. The prescription process is not consistent with the original drug, but the imitation drug must be consistent with the quality and efficacy of the original drug.

9. What are the changes in the technical standards under the new registration category?

Implement new technical standards for review of chemical registration applications filed under the new registration classification. Among them, for innovative drugs, the first is to emphasize "innovation", that is, it should have a "global new" material structure, the second is to emphasize the clinical value of drugs; for improved new drugs, the emphasis on "superiority" is that The improved medicine has obvious clinical advantages; for generic drugs, the emphasis is on "consistency", and the generic drugs are the original drugs, and the quality and efficacy should be consistent with the original drugs.

10. How is the monitoring period setting for the new registration classification considered?

Article 34 of the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" stipulates that the drug regulatory department of the State Council may, in accordance with the requirements for the protection of public health, establish a monitoring period of no more than five years for new drug varieties produced by pharmaceutical manufacturers. The first category and the second category in the new registration category belong to the new drug category, so the monitoring period is set. At the same time, with reference to the monitoring period setting of the original chemical drug registration classification in the Drug Registration Management Measures, the corresponding monitoring period is set for the similar or similar situation in the new registration classification.

XI. How to transfer the original registration application that has been accepted after the implementation of the new registration classification?

After the implementation of the scheme, the newly filed chemical registration application (including clinical, production, and import applications) shall be applied, and the registration classification shall be implemented in accordance with the relevant requirements of the new registration classification.

Before the implementation of the scheme, the applications for registration of production of chemical products No. 3 and Category 6 that have not yet completed the review and approval have been accepted. The applicant may choose to continue to review and approve according to the original regulations. If the requirements are met, the registration category shall be registered upon approval. The corresponding original registration classification; applicants may also apply for follow-up declaration, review and approval according to the new registration classification.

For the application for registration for review and approval according to the new registration classification, the drug examination center of the Food and Drug Administration shall prioritize the examination and approval according to the requirements of the new registration classification; if the examination does not meet the requirements, no additional information will be requested, and the information will not be directly Approved.

12. How to implement the “replenishment of related expenses” in the plan?

The “relevant related expenses” mentioned in part (4) of the “II. Relevant registration requirements” refers to the application for registration of chemical drugs that has been accepted before May 27, 2015, and the application for review and approval according to the new registration classification. The relevant registration fees shall be paid in accordance with the "Regulations on the Registration Fees for Pharmaceuticals and Medical Device Products" promulgated in the "Notice on the Registration Fees for the Registration of Pharmaceuticals and Medical Device Products" (No. 53 of 2015); the application will be accepted after May 27, 2015. If the application for registration of a chemical that has been paid in accordance with the above criteria is applied for review and approval in accordance with the new registration classification, no additional fees are required.

13. After the implementation of the new registration classification, what are the detailed work requirements?

After the implementation of the new registration classification, the General Administration of Food and Drug Administration will organize relevant departments to submit the “New Registration Classification Application Items and Requirements”, the “New Registration Classification Acceptance and Inspection Guide”, the “New Registration Classification Verification Checkpoint”, and the “New Registration Classification Technology” as soon as possible. A series of related refinement work requirements, including the Review Guiding Principles, etc., in order to guide applicants to rationally research and develop relevant products and further improve the quality of drugs.

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