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Common problems

Classification of chemicals

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  1. Drugs not marketed at home and abroad:

  (1) API and its preparations obtained by synthetic or semi-synthetic methods;

  (2) new effective monomers and their preparations extracted from natural substances or extracted by fermentation;

  (3) optical isomers and their preparations in known drugs obtained by the method of separation or synthesis;

  (4) preparation of a smaller number of drugs from a plurality of drugs sold on the market;

  (5) new compound preparations.

  2. Change the way of drug delivery and have not been marketed at home and abroad.

  3. Drugs that have been marketed abroad but have not been marketed in China:

  (1) the API and its preparations that have been marketed abroad;

  (2) compound preparations that have been marketed abroad;

  (3) drugs that have changed the way they are administered and have been marketed abroad.

  4. Change the acid root, base (or metal element) of saline-type drugs that have been sold on the market, without changing the pharmacological action of the API and its preparations.

  5. Change the dosage forms of drugs that have been sold on the market in China, but do not change the way of drug delivery.

  6. There is already a national drug standard API or preparation.

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