The Measures for the Supervision and Administration of Drug Production have recently been updated in China, with a focus on ensuring the quality and safety of pharmaceutical products. The new regulations emphasize the need for continuous compliance throughout the entire production process, from the raw materials to the finished products. The measures also highlight the importance of adhering to quality management standards and pharmaceutical standards.
Under the new regulations, pharmaceutical companies are responsible for ensuring that their production processes comply with all legal requirements. This includes the responsibility for releasing drugs for sale and for monitoring the quality of products that have already been sold. The new regulations also establish a risk-based approach to monitoring, with a focus on high-risk drugs that require increased scrutiny.
To implement these regulations, the government will establish a new system of professional inspectors who are trained to spot potential problems and take appropriate action. In addition, a risk-based approach to inspections will be implemented, with a focus on high-risk drugs and the potential consequences of their use.
To ensure that pharmaceutical companies comply with these new regulations, strong penalties will be imposed for non-compliance. Companies that are found to be in violation of the regulations may face penalties such as suspension of production, sales, use, or importation of drugs, as well as other penalties in proportion to the severity of their violations.
Overall, the new regulations represent a significant step forward in ensuring the quality and safety of pharmaceutical products in China. By implementing these measures, the government hopes to enhance public health and promote the development of a thriving pharmaceutical industry in China.