Draft Administrative Order "Rules and Regulations on the Issuance of Authorization for Registration Applications of Drug Products and Drug Substances by the Food and Drug Administration"

Other (TBT)

Health care technology (ICS code(s): 11); Food technology (ICS code(s): 67); Chemical technology (ICS code(s): 71)

Link to ePing

11 - Health care technology; 67 - Food technology; 71 - Chemical technology

A. This Administrative Order is issued to provide the guidelines including the rules and regulations on registration applications for the issuance of FDA authorizations and other certifications for drug products and drug substances._x000D_ B. Specifically, this AO shall provide the regulatory guidelines for the following:_x000D_ 1. Identification of registrable drug products and drug substances;_x000D_ 2. Types of registration applications for drug authorization;_x000D_ 3. Regulatory review implemented by the FDA on the applications and the applicable evaluation routes; and_x000D_ 4. Regulatory decisions on the applications.

1:File here 2:File here 3:File here 4:File here 5:File here 6:File here

EN:File here

FR:File here

ES:File here

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