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Notice on Publicly Soliciting Opinions on the "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)"

 Last Update: 2021-08-10
 Source: Internet
 Author: User

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In recent years, the research and development and application of biosimilar drugs has increased
.

Clinical pharmacology research is an important content in the comparison of biosimilar drugs, and it is very important to support the similarity evaluation of the effectiveness and safety of biosimilar drugs and reference drugs

We sincerely welcome valuable comments and suggestions from all walks of life on the solicitation draft, and timely feedback to us for follow-up improvement
.

The time limit for soliciting opinions is 1 month from the date of publication

Please send your feedback to the mailbox of the following contact:

Contact: Wang Yuzhu; Li Jian

Contact: wangyzh@cde.

Thank you for your participation and great support

Drug Evaluation Center of the State Drug Administration

July 8, 2021

attachment1 :	"Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)". pdf
Annex 2:	Drafting Instructions for "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Comment)". pdf
Annex 3 :	"Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)" feedback form. docx

attachment1 : "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)".
pdf Annex 2: Drafting Instructions for "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)".
pdf Annex 3: "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)" feedback form.
docx Annex 1: "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)".
pdf Annex 1: "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)".
pdf "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)".
pdf Annex 2: Drafting Instructions for "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)".
pdf Annex 2: Drafting Instructions for "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Comment)".
pdf Drafting Instructions for "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)".
pdf Annex 3: "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Comment)" feedback form.
docx Annex 3: "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)" feedback form.
docx "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Solicitation of Comments)" feedback form.
docx

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