The newly revised Pharmaceutical Administration Law, implemented on 1 December 2019, establishes the marketing authorization holder (MAH) system, which is internationally used in the pharmaceutical industry as a basic system for the administration of pharmaceuticals in China. Article 30 of the law specifies that the scope of responsibility of an MAH covers the entire process for the administration of pharmaceuticals, from pre-marketing to post-marketing.
While bestowing rights on and offering conveniences to the MAH, the law also stipulates the obligations and responsibilities that the MAH is required to perform, the most important being the responsibility of quality management. Article 6 of the law provides for the quality management responsibilities of the legal representative of the MAH, i.e., “responsibility, in accordance with the law, for the safety, effectiveness and quality controllability of the entire process, including research and development, production, distribution, and use of the pharmaceuticals”.
Chapter 3 of the law provides for the quality management responsibilities of the MAH and states that the MAH’s performance of its quality management obligations is a condition and the basis to entitle its rights, e.g., the MAH is required to conduct regular reviews of the quality management system of a pharmaceutical manufacturing enterprise commissioned to do so.
In order to assist with implementation of the law, a series of supporting measures and regulations have been successively issued, of which the newly revised Measures for the Administration of Drug Registration (MADR) and the Measures for the Supervision and Administration of Drug Production (MSADP) both entered into effect on 1 July 2020, further refining and clarifying the quality management responsibilities of the MAH. Pursuant to the above-mentioned laws and regulations, the MAH’s quality management responsibilities include establishing a quality assurance system, marketing clearance system, and pharmaceutical recall system.
Quality assurance system
Article 31 of the law provides as follows: “A pharmaceutical marketing authorization holder shall establish a pharmaceutical quality assurance system and assign dedicated personnel to be independently responsible for pharmaceutical quality management. A pharmaceutical marketing authorization holder shall conduct regular reviews of the quality management system of the commissioned pharmaceutical manufacturing enterprises and pharmaceutical distribution enterprises, and supervise their continuing process capabilities for quality assurance and control.”
On this basis, the pharmaceutical quality assurance system requires the MAH to assume full responsibility for the quality of its pharmaceuticals, and strictly perform such responsibilities as assigning dedicated personnel, reviewing quality management systems, and supervising quality assurance and control capabilities.
The law requires the MAH to have a person in charge of quality management (as specified in articles 6 and 28 of the MSADP), who is mainly responsible for pharmaceutical quality management and supervision of the implementation of quality management regulations. Furthermore, pursuant to article 15 of the MSADP, the person in charge of production, the person in charge of quality, and the qualified person are to be indicated on the drug production licence, together with the name and domicile (place of business) of the enterprise and the legal representative or person in charge of the enterprise as registered matters. If the MAH violates the law, or supporting measures or regulation, the legal liability can be accurately laid at the feet of the person in charge of quality management.
Additionally, the law requires the MAH to perform its regular reviewing and supervision responsibilities. The purpose of this provision is to further clarify that although a pharmaceutical manufacturing enterprise or distribution enterprise in pharmaceuticals is responsible for their acts of pharmaceutical production or distribution, the MAH bears the responsibilities of reviewing and supervising the manufacturing and distribution enterprises, and the MAH’s responsibilities do not transfer to the manufacturing enterprises or distribution enterprises.
Marketing clearance system
Article 33 of the law and article 37 of the MSADP specify the marketing clearance rules that the MAH is required to establish, and require the conduct of a review of the pharmaceutical manufacturing enterprise’s delivery clearances of pharmaceuticals, with their release only permitted after the signature of the qualified person. Those pharmaceuticals that do not meet state pharmaceutical standards may not be released.
If the MAH and pharmaceutical manufacturing enterprise are the same entity, the delivery clearances and marketing clearance procedures may be combined into a single clearance procedure. If, however, the MAH and pharmaceutical manufacturing enterprise are different entities, both the delivery and marketing clearance procedures and requirements are required to be carried out.
As the entity that is responsible during the full life cycle of pharmaceuticals, the MAH has a better understanding of the characteristics and properties of the pharmaceuticals, from research and development to manufacturing, and all stages in between, and is thus more appropriate as the gatekeeper for marketing clearance. For the MAH, the attribute of responsibility in marketing clearance is far greater than the attribute of rights.
Pursuant to article 28 of the MSADP, the MAH is required to have a dedicated qualified person to independently perform pharmaceutical marketing responsibilities. Similarly, the dedicated qualified person will be recorded on the drug production licence, and likewise bear legal liability under the law.
Having good quality management capabilities is one of the bases for the MAH to enjoy its rights under the MAH system, and is also the main responsibility and obligation it bears under the law. Quality management capabilities are not limited to the quality assurance system and marketing clearance system, but also include the pharmaceutical recall system, management of commissioned production, and distribution.
Taking a panoramic view of the entire quality assurance system, it is not difficult to see that the system is based on the principle of the MAH system, i.e., the MAH is responsible for pharmaceutical quality management throughout the life of a pharmaceutical. That is because pharmaceutical quality is the lifeblood of a pharmaceutical enterprise, and the cornerstone of its development.
Zhong Yueping is a partner at Merits & Tree Law Offices. Chen Yibo, a paralegal at the firm, also contributed to this article
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