Regulatory New Regulations for Pharmaceutical Excipients Concerned by the Industry

On August 2, the “Regulations on Strengthening the Supervision and Administration of Pharmaceutical Excipients” issued by the State Food and Drug Administration (hereinafter referred to as the “Regulations”) received extensive attention from all walks of life, especially the industry.

Zhang Shide, vice president of the China Pharmaceutical Packaging Association, commented that the "Regulations" are the most detailed, comprehensive, specific, and systematic documents issued by the State Bureau in the supervision of pharmaceutical excipients in recent years. They are aimed at ensuring the safety of pharmaceutical excipients. Strong and operational. "I believe that the promulgation of the "Regulations" will play an important role in purifying the market environment, safeguarding the order of the market economy, and ensuring people's drug safety. I am looking forward to this," said Zhang Shide.

Professor Tu Jiasheng, professor of the China Pharmaceutical University and deputy chairman of the Pharmaceutical Compounds and Pharmaceutical Packaging Materials Committee of the China Pharmacopoeia Committee, believes that the “Regulations” categorize management of medicinal excipients, which is in line with the actual situation of the current excipient industry in China (the credibility is not high, Enterprises are numerous, small, scattered, and chaotic. They are also in line with international practices. They are major measures that comply with the requirements for the production and management of pharmaceuticals and will certainly promote the production, use, and management of pharmaceutical excipients in China in line with international standards.

Zhang Shide analyzed that compared with the past, the "Regulations" strengthened supervision from the following aspects. First of all, the “Regulations” clarified the main body of responsibility. The formulation enterprises that use medicinal excipients must be controlled from the source and require the responsible entities to establish a quality management system, and sign quality assurance agreements with suppliers of pharmaceutical excipients to regularly audit suppliers. , strict "import" clearance.

Secondly, the “Regulations” put forward a clear requirement for pharmaceutical excipients manufacturers that pharmaceutical excipients manufacturers must regularly audit their upstream suppliers in order to ensure their own product quality and responsibility.

Finally, the “Regulations” also put forward requirements for food and drug regulatory authorities at all levels, that is, to supervise the use of pharmaceutical excipients in accordance with the principle of classification and supervision.

Then, what is the impact of the "Regulations" on the pharmaceutical excipients industry? Tu Jiasheng believes that the "Regulations" require pharmaceutical excipient manufacturers must organize production in accordance with the provisions of GMP, food and drug regulatory authorities must also comply with the relevant requirements of GMP inspection of pharmaceutical excipients production companies, which will inevitably force some non-standard medicinal The auxiliary material production enterprises withdrew from the market, thereby purifying the market environment and further enhancing industrial concentration. At the same time, after the implementation of the “Regulations”, it will significantly increase the volume and standard level of pharmaceutical excipients in the Chinese Pharmacopoeia. This is a good opportunity and a great challenge for manufacturers of pharmaceutical excipients, and competitive companies will surely come to the fore. Helps companies grow bigger and stronger. The "Regulations" emphasizes that pharmaceutical manufacturers must use pharmaceutical excipients that meet the requirements for the production of pharmaceuticals, and impose stricter requirements on pharmaceutical manufacturers to select and change excipient suppliers. This will facilitate the establishment of a more stable supply and sales relationship between drug manufacturers and pharmaceutical excipient manufacturers, and fully mobilize the enthusiasm of pharmaceutical excipient manufacturers to improve product quality.

Zhang Shide believes that after the "Regulations" are implemented, the business behavior of the pharmaceutical excipients industry has a legal basis, which helps to clarify the relationship between the pharmaceutical excipients industry and the pharmaceutical industry. The pharmaceutical excipients industry will pay more attention to the dynamics of its upstream suppliers, and will consciously go for a good "import." In short, the implementation of the "Regulations" will have a positive effect on the self-regulation, quality, and sense of responsibility of the pharmaceutical excipient industry.

Zhang Shide also proposed that the supervision of medicinal excipients is a long-term and complicated process that cannot be completed overnight. "I believe that we can select mature varieties of small categories to promote the implementation of pharmaceutical excipients GMP, the State Pharmacopoeia can also be included in the standards of pharmaceutical excipients for the safety of drugs and drugs, which is to promote the progress and development of the pharmaceutical excipient industry to It's important."

As a representative of pharmaceutical excipient manufacturers, Yin Zhenglong, chairman and general manager of Anhui Sanhe Pharmaceutical Excipient Co., Ltd., said in an interview on August 3 that pharmaceutical excipient manufacturers expressed their support and welcoming of the “Regulations”. .

Yin Zhenglong said that the promulgation of the "Regulations" has clarified the responsibility of pharmaceutical excipient manufacturers, and through the crackdown on illegal and irregular enterprises, it can create a good market environment for fair competition among enterprises.

China's pharmaceutical industry is in a critical period of industrial transformation and upgrading. Pharmaceutical excipient manufacturers should strive to improve product quality, develop new products, and seek greater development.

Yin Zhenglong believes that at this stage, accelerating the standardization process of pharmaceutical excipients and improving the organization of industry associations will be more conducive to the healthy and orderly development of the pharmaceutical excipients production industry.