In February 2023, Shenyang DASAN Pharmaceutical Technology Co., Ltd. obtained the Pharmaceutical Manufacturing License, marking the company's transformation into a Marketing Authorization Holder (MAH).

In accordance with the requirements of the Marketing Authorization Holder system, Shenyang DASAN restructured its organizational framework, merging the original R&D system documentation with the new MAH system documentation. It re-established the MAH system documents and built a pharmaceutical quality assurance system, taking responsibility for the quality of drugs marketed and sold.

The construction of the MAH system covers all stages of the product lifecycle. The MAH system documentation at least encompasses the following aspects:

1. Management of MAH organizational structure and responsibilities

2. Personnel management

3. Document management

4. Quality control and quality assurance

5. Drug traceability management

6. Pharmacovigilance management

7. Manufacturing supervision management system

8. Annual reporting system

The Marketing Authorization Holder (MAH) system is a regulatory model where non-manufacturing entities such as pharmaceutical research institutions or researchers, or pharmaceutical manufacturing companies, obtain drug-related technologies and become MAHs through drug marketing applications. MAHs can choose to manufacture the drug themselves or entrust other pharmaceutical manufacturers to produce it. The MAH bears the primary responsibility for the entire lifecycle of the drug.

For MAHs that entrust other companies with activities related to drug development, manufacturing, distribution, and pharmacovigilance, their quality assurance system must effectively integrate with the quality assurance system of the entrusted company. They must fulfill the responsibility for drug market release, be accountable for the quality of the drug for which they hold the drug registration certificate, and ensure the drug's safety, efficacy, and quality control throughout its lifecycle.