Heavy: CDE has focused on clinical trials of improved new drugs for children's chemicals

On April 13, 2021, the official website of the Center for Drug Evaluation of the National Medical Products Administration issued the " Technical Guidelines for Clinical Trials of Modified New Drugs for Children's Chemicals (Draft for Comment)", and the deadline is May 12, 2021
.
This guideline is to encourage the development of new and improved chemicals for children based on the characteristics of children's growth and development and the needs of pediatric clinical practice based on the clinical needs of pediatrics in China

1.
Regulatory definitions related to improved new drugs

Formulation improvement is one of the important ways for new drug research and development.
After the implementation of the "Administrative Measures for Drug Registration" that China implemented on July 1, 2020, the registration of chemical drugs is classified into 5 categories, namely, innovative drugs that have not been marketed at home or abroad, and domestically unlisted innovative drugs.
Improved new drugs that have not been listed abroad, drugs that domestic applicants imitate overseas but not domestically marketed original research drugs, domestic applicants imitate drugs that have been listed domestically, and drugs that have been listed overseas apply for listing in China; according to the "Chemical Drugs" "Registration Classification and Application Information Requirements", the improved new drugs that have not been marketed at home or abroad belong to the second category of new drugs (subdivided into four categories 2.
1, 2.
2, 2.
3, and 2.
4), which means that their structure is based on the known active ingredients.
Drugs with obvious clinical advantages through optimization of dosage form, prescription process, route of administration, indications, etc.
; improved drugs marketed overseas belong to category 5.
1, regardless of category 2 or 5.
1, improved drugs are required to have obvious clinical Advantage is the key condition.
The definition is excerpted as follows:

♦ Class 2.
1, containing optical isomers of known active ingredients prepared by resolution or synthesis, or forming esters with known active ingredients, or forming salts with known active ingredients (including hydrogen bonds or coordination Bond salt), or change the acid radical, base or metal element of the active ingredient of known salt, or form other non-covalent bond derivatives (such as complex, chelate or clathrate), and have obvious clinical Advantage of medicine
.

♦ Class 2.
2, new dosage form (including new drug delivery system), new prescription technology, new route of administration with known active ingredients, and drugs with obvious clinical advantages
.

♦ Class 2.
3, a new compound preparation with known active ingredients, and has obvious clinical advantages
.

♦ Category 2.
4, drugs with new indications containing known active ingredients
.

♦ In category 5.
1, original research drugs and modified drugs that are listed overseas apply for listing in China
.
Improved drugs should have obvious clinical advantages

       2.
Common improvements and cases of improved new drugs for children

       To provide children with safe, effective, controllable quality and suitable for children of different ages is the goal of children's drug development
.
Optimizing improved new drugs with obvious clinical advantages for children on the basis of known active ingredient drugs is a common choice for expanding children's applications.

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       references

       [1] http://       About the author: Drip Sinan, male, senior engineer in biomedicine, based on the quality management of the biomedical industry, focusing on the biomedical industry