TheNational Medical Products Administrationhas recently released theRequirements for Registration Classification and Application Dossier of Chemical Productsfor the implementation of theProvisions for Drug Registration.The requirements for the registration classification of chemical products took effect on 1 July ...
1.2 Changes of Drug Classification The New Provisions have combined and followed the rules in the previous version of “Provisions for Drug Registration” and “Reform Scheme for Registration Classification of Chemical Drugs” to classify drug registrations as follows: ...
Enterprises that intend to register existing chemical substances within the registration grace period shall individually apply for registration, but in cases of the data for application for registration such as test data for hazards of chemical substances, they shall jointly submit such da...
Q8: Should the applicant organize the chemical API filing documents according to theNotice of Chemical Drugs’ New Registration Classification and Application Document Requirements (Trial)(No. 80 Announcement in 2016)? A8: The applicant should conduct researches according toNMPA...
The current classification is mainly defined based on the marketing status of drugs in China, e.g., for new chemical drugs, Class 1 refers to a new drug that has never been marketed in any country, while Class 3 refers to a new drug that has been marketed outside of China, but not ...
Fig. 1 Number of Applications of Each Application Type from 2016 to 2019 1.3 Overview of Approval The table below (Table 4) shows the number of applications approved under each registration classification of chemical drugs, including Investigational New Drug (IND), New Drug Application (NDA)...
Classification and labelling; Physical and chemical properties; Uses; Hazard characteristics; Safety requirements for storage, use and transportation; Emergency response measures in case of dangerous situations. Registration procedures Our Services Safety Data Sheet and label preparation ...
The current classification is mainly defined based on the marketing status of drugs in China, e.g., for new chemical drugs, Class 1 refers to a new drug that has never been marketed in any country, while Class 3 refers to a new drug that has been marketed outside of China, but not ...
Ingredient characterization through relevant physico-chemical data, purity and profile of impurities or additives ; Source of the ingredient(like synthesis, animal source or plant extract); Data on pesticide residues and other impurities brought in during the extraction process in case of ingredient ...
The detailed classification of TCMs, chemical drugs, biological products and other drugs, as well as the corresponding requirements on application dossiers, shall be formulated by the National Medical Products Administration (hereinafter referred to as “NMPA”) according to the product characteristics...