Popular science of raw material medicine: what is raw material medicine and the difference between raw material medicine and intermediate

1. What is raw material medicine?

Raw material drug refers to the raw material drug used in the production of various preparations. It is the active ingredient in the preparation and cannot be directly taken by patients.
The complete definition of API in ICHQ7A: any substance or mixture of substances intended to be used in the manufacture of pharmaceuticals, and when used in pharmaceuticals, becomes an active ingredient of pharmaceuticals. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, alleviation of symptoms, treatment or prevention of diseases, or can affect the function or structure of the body.

2. What is the difference between APIs and intermediates?
1. Different definitions
(1) Intermediate: Intermediate: A material that is produced in the process steps of APIs and must undergo further molecular changes or refining to become APIs. Intermediates may or may not be isolated.
(2) API: Active Pharmaceutical Ingredient (API) (or Drug Substance) – Active Pharmaceutical Ingredient: Any substance or mixture of substances intended for use in the manufacture of pharmaceuticals, and when used in pharmaceuticals, becomes an active ingredient. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment or prevention of diseases, or can affect the function and structure of the body.
It can be seen from the definition that the intermediate is the key product of the previous process of making the raw material drug, which has a different structure from the raw material drug. In addition, there are detection methods for raw materials in the Pharmacopoeia, but not for intermediates.
2. Differences in certification
(1) Intermediates (FDA) At present, FDA requires intermediates to be registered, while CEP does not, but CTD documents must have detailed process descriptions of intermediates. In China, there is no GMP mandatory requirement for intermediates.
(2) The raw material drug (API) is submitted by the API company. If the API synthesis route is very simple, such as only one-step reaction, the FDA believes that the risk control is insufficient, and it is very likely to extend the inspection of the intermediate. Intermediate management is generally in accordance with ISO or combined with Q7a, and quality system management is sufficient.
3. From the perspective of new drug development
(1) API is a compound that can be safely used in human body for therapeutic diagnosis after sufficient pharmaceutical research.
(2) Intermediates are compounds in the process of synthesizing raw materials, which do not necessarily have therapeutic effects or toxicity. Note that what is said here is not necessarily the case. Some intermediates in the synthesis of APIs are also APIs.
4. From the perspective of pharmaceutical management
(1) APIs should apply for registration to the drug regulatory authority (the State Food and Drug Administration in China, the FDA in the United States, and the EMA in Europe) according to the law. Synthesized in a GMP-compliant factory.
(2) Intermediates are only intermediate products in the process of synthesizing raw materials, and do not need to obtain a document number. It should be noted that the compound that is the same as the API is not an API if it has not obtained a document number or is not produced in a GMP plant.

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