Legal Analysis: Article 1 These rules are formulated in order to standardize drug pricing behavior and improve the scientific nature and transparency of drug pricing.
Article 2: These rules apply to government-priced and government-guided price drugs (referring to pharmaceutical preparations).
Article 3 These rules classify government-priced and government-guided price drugs according to the needs of price management.
For Western medicines subject to government pricing or government-guided prices, pharmaceutical preparations with the same chemical composition expressed in the Chinese common name or English International Nonproprietary Name (INN) are classified as the same type of medicine (chemical composition The same, if the base, acid radical and solvent in the naming are different, they are classified as the same medicine);
For Chinese patent medicines subject to government pricing or government-guided prices, the first part of the dosage form in the official name stipulated by national standards Pharmaceutical preparations with the same name and the same prescription specified by national standards are classified as the same kind of drugs (those with the same prescription and different official product names are classified as the same kind of drugs).
Article 4 The definitions of dosage forms, specifications and medicinal packaging materials referred to in these rules are based on the relevant regulations of the State Food and Drug Administration.
Legal basis: "Standardization Law of the People's Republic of China" Article 2 The standards (including standard samples) mentioned in this law refer to the need for unification in the fields of agriculture, industry, service industry, social undertakings, etc. technical requirements.
Standards include national standards, industry standards, local standards, group standards, and enterprise standards. National standards are divided into mandatory standards and recommended standards, while industry standards and local standards are recommended standards.
Mandatory standards must be implemented. The state encourages the adoption of recommended standards.