In recent years, with the vigorous development of the pharmaceutical industry, the pharmaceutical packaging industry in its downstream industries has also ushered in a period of rapid development. The development of the industry is inseparable from the norms of the opening standards. Looking at the development history of the pharmaceutical packaging industry, it is actually the history of perfection of the industry's regulatory policies.
Compared with developed countries, my country's pharmaceutical packaging industry started late, but the speed of development is amazing. In 1978, the former State Administration of Pharmaceutical Administration was established, which opened a new phase of unified management and standardized development of my country's pharmaceutical field. So far, the supervision of my country's pharmaceutical packaging industry has gone through three stages, from enterprise production licenses, product registration approvals, to the review and approval of drug preparation registration applications.
"Administrative Measures for Drug Packaging (Trial)", "Production License for Pharmaceutical Packaging Materials and Containers", "Administrative Measures on Packaging Materials and Containers Directly Contacting Drugs", "Opinions of the State Council on Reforming the Review and Approval System of Drugs and Medical Devices", Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices, "Announcement of the General Administration on Adjusting the Review and Approval Items of APIs, Excipients and Packaging Materials"... After more than 40 years of deepening reforms, the National Pharmaceutical The Drug Evaluation Center of the Supervision Bureau has established a registration information platform for APIs, pharmaceutical excipients and pharmaceutical packaging materials. Relevant enterprises or units can submit the registration data of APIs, pharmaceutical excipients and pharmaceutical packaging materials through the registration platform, and after obtaining the registration numbers of APIs, pharmaceutical excipients and pharmaceutical packaging materials, they can be reviewed together with the registration application for pharmaceutical preparations.
In addition, comprehensive market trends such as volume procurement, drug consistency evaluation, and various policies for the healthy development of the industry have greatly promoted the high-quality development of the pharmaceutical packaging industry. As the country continues to increase investment in the medical industry, the pharmaceutical packaging industry's own regulatory policies continue to improve, and the pharmaceutical packaging industry will usher in long-term development.
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