Registration of new chemical substances

Answers to Frequently Asked Questions about the Environmental Management Measures for New Chemical Substances (Order No.7)

I recommend: For pre-registration projects with large tonnage and short grace period, or small tonnage pre-registration projects that are clearly registered in the future, it is recommended to choose joint registration and join the joint registration IT system agreement this time. For pre-registration projects that are clearly not registered in the future, it is recommended to choose subsequent registration. May I ask you

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Cancellation of GMP certification means stricter supervision of drug production?

The cumbersome process of GMP and GSP certification has made many pharmaceutical manufacturers and distribution companies feel the strict supervision of the pharmaceutical industry. On September 25, 2019, the State Food and Drug Administration issued a notice on the study, publicity and implementation of the the People's Republic of China Drug Administration Law., It is clearly proposed to strengthen dynamic supervision and cancel the drug production quality management practice (GMP) certification and the drug business quality management practice (GSP) certification.

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Dry goods! Common technical questions and answers on new raw materials for cosmetics

On July 8, 2024, the Chinese Academy of Inspection issued a (I) of common technical questions and answers on new raw materials for cosmetics and a (II) of common technical questions and answers on new raw materials for cosmetics.

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The newly revised "Medical Device Management Quality Management Standard" will be implemented on July 1, and these changes need attention.

Announcement No. 153 of the State Drug Administration on December 4, 2023, "Medical Device Business Quality Management Regulations" will come into force on July 1, 2024. The Announcement of the former State Food and Drug Administration on the Implementation of Medical Device Business Quality Management Standards (No. 58 of 2014) shall be abolished at the same time.

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Interpretation! Historical evidence for the safe use of new cosmetic raw materials in China

On May 31, 2024, the Central People's Procuratorate issued a notice on publicly soliciting opinions on the "Guidelines for the Study and Determination of the Safe Use of New Cosmetic Raw Materials (Trial) (Draft for Solicitation of Comments)" (hereinafter referred to as the "Draft for Solicitation of Comments"). On the basis of the "Regulations on the Administration of Registration and Filing Materials of New Cosmetics Raw Materials" (hereinafter referred to as the "Regulations"), the draft for comments further clarifies the details of the relevant data requirements for the safe use of new raw materials. The following is a summary of the contents of the regulations and a sharing of our views for your reference.

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