Drugdu.com expert's response:

The "Pharmaceutical Administration Law of the People's Republic of China" plays a crucial role in ensuring the quality and safety of drugs. Here are several key aspects of its role in this regard:

Ⅰ. Defining and Classifying Drugs

Article 2 of the Pharmaceutical Administration Law clearly stipulates that the drugs referred to in this Law are substances used for the prevention, treatment, and diagnosis of human diseases, for the purposeful regulation of human physiological functions, and with specified indications or functional indications, usage, and dosage, including traditional Chinese medicines, chemical drugs, and biological products. This definition clarifies the scope and classification of drugs, providing a legal foundation for subsequent regulatory work.

Ⅱ. Establishing Strict Regulations for Drug Research and Development, Production, Operation, and Use

Research and Development: Article 29 of the Pharmaceutical Administration Law stipulates that the research and development of new drugs must be conducted in accordance with the regulations of the drug regulatory authorities under the State Council, with truthful submission of research methods, quality indicators, pharmacological and toxicological test results, and other relevant materials and samples. Clinical trials can only be conducted after approval by the drug regulatory authorities under the State Council. This ensures that new drugs undergo thorough scientific research and safety assessments before being marketed.

Production: The Law requires drug manufacturing enterprises to formulate and implement strict Good Manufacturing Practices (GMP) to ensure quality control and safety during the production process.Meanwhile, medical institutions must also formulate and implement drug storage systems, taking necessary measures such as refrigeration, antifreeze, moisture protection, insect prevention, and rodent control to ensure drug quality (mentioned in Article 20 of the 2015 amended version and Article 28 of the 2023 current version).

Operation: Drug distribution enterprises need to comply with Good Supply Practice (GSP) to ensure the quality and safety of drugs during circulation.

Use: Medical institutions and medical staff must follow drug instructions and diagnostic norms when using drugs to ensure the safety and effectiveness of medication.

III. Strengthening Drug Supervision and Management and Punishment Severity

The Pharmaceutical Administration Law clearly stipulates the responsibilities and powers of drug regulatory authorities, including supervision and inspection, sampling inspection, and quality announcements for drug research and development, production, operation, and use. For violations of the Pharmaceutical Administration Law, administrative penalties will be imposed according to the law, and criminal responsibilities will be pursued for those constituting crimes. This effectively cracks down on illegal activities such as the production and sale of fake and inferior drugs, safeguarding public drug safety.

Ⅳ. Promoting Continuous Improvement in Drug Quality and Safety Levels

The Pharmaceutical Administration Law also encourages and supports drug research and development innovation, promoting continuous improvement in drug quality and safety levels. By continuously improving the drug evaluation and approval system, strengthening the monitoring and reporting system for drug adverse reactions, and other measures, the safety and effectiveness of drugs are continuously enhanced.

In summary, the "Pharmaceutical Administration Law of the People's Republic of China" plays a crucial role in ensuring the quality and safety of drugs. By defining and classifying drugs, establishing strict regulations for drug research and development, production, operation, and use, strengthening drug supervision and management and punishment severity, and promoting continuous improvement in drug quality and safety levels, it effectively safeguards public drug safety and health.