The author understands that due to the late start of my country's pharmaceutical excipient industry and the imperfect quality standards, the market is still in the stage of gradual standardization, showing a "small, scattered, chaotic" situation. The frequent occurrence of "drug damage" incidents in recent years has attracted the attention of domestic drug regulatory authorities, and the supervision model and management system of pharmaceutical excipients need to be improved urgently.
In 2006, in order to strengthen the quality management of medicinal excipient production and ensure the quality of medicinal excipients, my country formulated the "Quality Management Standards for Pharmaceutical Excipient Production". Under the fermentation of the "sulfonamide elixir event", the defects in the registration system for pharmaceutical excipients were exposed, prompting my country to reform the management system for pharmaceutical excipients.
In 2008, my country's drug regulatory authorities began to explore the reform of the management model of raw and auxiliary materials for pharmaceutical use.
In 2012, my country issued the "Regulations on Strengthening the Supervision and Administration of Pharmaceutical Excipients", which further clarified the supervision mode of pharmaceutical excipients and urged pharmaceutical preparation manufacturers to strictly control the excipients used in pharmaceutical production.
In May 2017, the "Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices to Accelerate the Review and Approval of New Drugs and Medical Devices" (Draft for Comment) was issued, clearly proposing the formulation of management methods for the filing of pharmaceutical raw materials and packaging materials, and the establishment of raw materials And the packaging material filing information platform, relevant companies submit filing information as required and are responsible for the authenticity of the filing information, further clarifying the main responsibility of pharmaceutical manufacturers for drug quality.
In the past two years, my country has effectively strengthened the daily supervision of pharmaceutical excipient manufacturers, strengthened the extended inspection of pharmaceutical excipients, and ensured the quality of medicines.
Medicinal excipient standard system is constantly improved
With the continuous development of the industry, China has now formed a batch of pharmaceutical excipient enterprises with a certain scale and operating standards, and has strong market competitiveness, but most enterprises are still small in size, single product, and insufficient standardization. Weak competitiveness.
In 2018, with the deepening reform of domestic pharmaceutical policies and regulations, with the promotion of the consistency evaluation of generic drugs and the consistency evaluation of injections, the pharmaceutical excipient industry gradually entered the integration stage, and the concentration has continued to increase. Enterprises are urgently required to improve product quality, R&D and innovation capabilities and Technical level, at the same time need a more complete standard system to support development. In this context, the industry has put forward higher requirements for the quality and regulatory support of pharmaceutical excipients, and the solicitation of opinions on the standards for pharmaceutical excipients is constant.
For example, in April 2018, the National Pharmacopoeia Commission issued a notice to publicly solicit opinions on 12 draft standards for pharmaceutical excipients such as mannitol.
In addition, according to the 2020 edition of the Pharmacopoeia, we will focus on increasing the inclusion of standards for raw materials, Chinese medicinal materials, and pharmaceutical excipients. The draft for solicitation clearly stated that further strengthen and improve the pharmacopoeia standard system of pharmaceutical excipients and packaging materials, increase the collection of commonly used pharmaceutical excipients and pharmaceutical packaging materials standards, and promote the collection of mature new pharmaceutical excipients and pharmaceutical packaging materials standards The focus is on strengthening the formulation of excipients for high-risk preparations (injections, ophthalmic preparations, inhalation preparations, and animal sources); advancing the replacement of pharmaceutical excipients and pharmaceutical packaging materials.
Judging from the continuous publicity of the draft standards revisions this year, the pharmaceutical excipient industry will be developed more scientifically.