On the afternoon of April 25, to promote the implementation of the Announcement on Issues Pertaining to the Implementation of the Newly Revised Provisions for the Supervision and Administration of Drug Production, the Provisions on the Supervision and Administration of the Fulfillment of Medicinal Product Quality and Safety Responsibilities by Holders of Authorization for Medicinal Products, and the Announcement on Enhancing the Supervision and Management of Contract Manufacturing for Drug Authorization Holders, and to further understand the situation of contract manufacturing carried out by Anhui Medical Products Administration, NMPA visited Huayi (as the C-license contract manufacturer) for research (discussion) on the specific situation.
Hu Zengyao (Director) and Sun Qiang from the Division of Supervision II, the Drug Regulation Department of the NMPA, Wang Yuxiang (Director) from the Drug Production Regulation Department of the Anhui Medical Products Administration, and Wang Cheng (Director) from the First Branch visited Huayi for research (discussion), understand the specific situation of contract manufacturing and experiences for contract manufacturing from foreign markets subject to strict regulations.
As the start of the meeting, Gao Yu, Chairman of Huayi, gave a detailed introduction to the overall situation of the contract manufacturing, technology transfer and contract manufacturing management in Huayi and further discussions is made on “technical thresholds on which aspects to be properly raised, to promote the improvement of C-license quality and the intensive and high-quality development of contract manufacturing.” Subsequently, in-depth and comprehensive exchanges and discussions were made between two parties on domestic and foreign policies and regulations, production management, quality management, technical levels, and how to effectively connect the quality systems of B-license and C-license etc.
Finally, the NMPA experts gave overall recognition to Huayi’s CDMO business and provided valuable suggestions. The experts stated that the MAH system is a good system established through legal means but requires strengthened management and guidance from both B-license and C-license to ensure the high-quality development of the industry. Regarding the management of C-license enterprises, the country will also issue further detailed regulations based on relevant research. The experts further pointed out that the intensive and high-quality development of CDMO can bring specialization and scale in pharmaceutical manufacturing, and they also hope that relevant enterprises will become bigger and stronger following the principles of regulatory compliance, professionalism, and intensification.
In the future, Huayi will continue to adhere to the corporate value of “create value and benefit for the world” and the corporate spirit of “keep pragmatic and innovative in pursuit of excellence” and contribute to the high-quality development of the pharmaceutical manufacturing industry.