浅析药品审评审批制度改革中“两证合一”对制药企业的影响

Analysis on the Impact of “Two Certificates in One” on Pharmaceutical Enterprises in the Reform of Drug Review and Approval

关键词:  制药企业  两证合一  药品  改革

Key words:  pharmaceutical enterprises  two certificates in one  medicines  reform

摘要:

目的 通过探讨实现"药品生产许可证和药品生产质量管理规范（Good Manufacturing Practices，GMP）证书合一"（以下简称"两证合一"）对制药企业的影响，提高监管效率，推动整个药品制造行业向高标准、严要求方向发展。方法 从我国药品GMP认证制度的现状出发，分析制药企业"两证合一"的优劣，进一步了解和掌握在药品GMP认证过程中存在的问题。结果 "两证合一"的有利影响是可以减轻企业负担、使企业能按GMP持续合规生产、加大药品检查力度、提高药品监管效率、强化监管人员队伍、完善企业自检管理体系及有利于中小企业兼并重组；不利影响是企业可能会放松对GMP的学习和管理、被收回药品GMP证书的风险增大、不能根据新的法律法规及时修订和更新企业工艺规程和操作规程。总体上是有利影响多于不利影响。结论 实现"两证合一"利大于弊。

Abstract:

OBJECTIVE To promote the development of the whole pharmaceutical manufacturing industry towards high standards and strict requirements, by discussing the impact of the realization of "two certificates in one"[combining Manufacturing Authorization Certificate and the Good Manufacturing Practices(GMP) Certificate] on pharmaceutical companies. METHODS Based on the current status of China's GMP certification system, analyzed the advantages and disadvantages of the "two certificates in one" of pharmaceutical companies, to understand the problem in the process of GMP certification. RESULTS The "two certificates in one" was beneficial to reduce the burden of enterprises, enable enterprises to continuously comply with GMP production, increase the intensity of drug inspection and improve the efficiency of supervision, strengthen the team of supervisors, improve the self-inspection management system of enterprises and facilitate the merger and reorganization of small and medium-sized enterprises. The disadvantage was that enterprises may relax their learning of GMP, study and management, risk of withdrawal of GMP certificate of pharmaceutical products increased, laws and regulations could not be revised and updated in time, but there were more advantages than disadvantages. CONCLUSION "Two certificates in one" is more advantageous than disadvantageous.