The heavy pharmaceutical policy is about to be implemented

Guide: Two weeks later, on December 30, the 2020 edition of the Chinese Pharmacopoeia will be officially implemented.

The new "Chinese Pharmacopoeia" is published in four parts and contains 5911 varieties, including 319 new varieties and 3177 revised products. The industry generally believes that the promulgation and implementation of the new version of the Pharmacopoeia will have a profound impact on the entire pharmaceutical industry, including boosting the quality of drugs, forcing industrial adjustments, and bringing development opportunities to the pharmaceutical-related industries.

Help improve drug quality 

The new version of "Chinese Pharmacopoeia" has gradually improved the drug standard elimination mechanism, improved the pharmacopoeial standard system, and strengthened the concept of full-process drug quality management, which is conducive to improving the level of drug quality control. Among them, there are product standards and method standards for pharmaceutical excipients and pharmaceutical packaging materials. New regulations have been introduced, and new requirements have been put forward for drug registration and supervision and inspection.

The industry believes that after the new version of the Chinese Pharmacopoeia is promulgated and implemented, relevant regulatory authorities will conduct random inspections on enterprises in accordance with the requirements and standards of the new version of the Pharmacopoeia to conduct random inspections of drugs, which will help further improve the quality of my country’s drugs and better guarantee The safety and effectiveness of medicines protect public health.

Force the adjustment of the pharmaceutical industry structure

The new version of the Pharmacopoeia sets out the concept of drug quality control, the collection of varieties, the formulation and improvement of general technical requirements, the application of inspection technology, inspection items and their limit standards, etc., which will guide pharmaceutical manufacturers to eliminate outdated technology and production capacity and promote The adjustment of industrial structure, promotion of product upgrading and optimization of production technology, etc. will help the high-quality development of my country's pharmaceutical industry.

At the same time, the new edition of the pharmacopoeia benchmarks against international standards, which is also conducive to improving the overall level of my country's drug standards, enhancing the international competitiveness of my country's products, and speeding up the "going out" of pharmaceutical products.

Testing equipment welcomes development space

In addition to ensuring drug quality, maintaining public health and safety, and promoting the high-quality development of the pharmaceutical industry, the implementation of the new version of the Pharmacopoeia will also bring development space to related industries, such as the analysis and testing equipment industry. The new edition of the Pharmacopoeia newly added the "Multi-residue determination method for 33 banned pesticides in medicinal materials and decoction pieces (plants)", formulated control requirements for 33 banned pesticides, and stipulated that "unless otherwise specified, medicinal materials and decoction pieces (plants) are prohibited Pesticides shall not be detected (not to exceed the limit of quantification)", and shall be included in the general rules for the verification of medicinal materials and decoction pieces. With the implementation of the pharmacopoeia, strengthening pesticide residue testing will become a major issue for Chinese medicine companies, and relevant analysis and testing equipment may play a significant role in drug quality control.

It is reported that in order to help Chinese medicine companies to deal with the challenges of testing under the new version of the Pharmacopoeia, many instrument and equipment manufacturers have already gained momentum. For example, a chromatographic instrument manufacturer has launched a comprehensive solution for the prohibition of pesticide residues in traditional Chinese medicine, which can provide professional after-sales technical support to help customers establish an analysis platform more quickly and familiarize themselves with each operation step required. At the same time, it can also provide Chinese medicine component analysis and Chinese medicine. Industry solutions such as formula particles, mycotoxins, and Chinese medicine metabolomics to ensure the quality of Chinese medicine.

Conclusion

Now that the implementation of the new pharmacopoeia is imminent, pharmaceutical companies need to make corresponding preparations. In the context of continuous improvement of the drug standard system and stricter industry supervision, companies can only go further if they produce and operate in compliance.