Asymchem recently developed “Tianjin Drug Administration Training Base” jointly with Tianjin Medical Products Administration (TMPA). The training base will promote communication and information sharing between the two sides. TMPA will be privy to Asymchem’s demand & development and able to promote the new drug administration model. At the same time, TMPA will provide Asymchem with a deeper understanding of laws, regulations and future information regarding drug administration related issues. This collaboration aims to boost the innovation and development of Chinese pharmaceutical companies.
“Tianjin Drug Administration Training Base” Opening Ceremony
On the afternoon of May 21, 2020, the opening ceremony of “Tianjin Drug Administration Training Base” was carried out at Asymchem. Xudong Wang (Director of TMPA), Zhihong Mei (Vice director of TEDA- Tianjin Economic Technological Development Area), Rui Yang (COO of Asymchem), and many other senior executives of Asymchem were present. With Shengxi Zhang (Vice director of TMPA) hosting the ceremony, Xudong Wang and Rui Yang signed the agreement and unveiled the nameplate to two representatives of the government and Asymchem, respectively.
Xudong Wang said, “TMPA insists on improving the quality management system of drug supervision, and enhancing the level of drug regulation comprehensively as a main line focus of work. We are accelerating the growth of a professional team of drug inspectors and promoting the full implementation of capability improvements, risk control and regulatory responsibilities. We will also further upgrade the level of government services, actively carry out "Policy + Technology" supporting activities to help enterprises develop sustainably. Regarding the joint construction of the training base, both TMPA and Asymchem should fully implement the spirit of the new law; make progress with strengthening regulative strategies, enterprise R&D (Research & Development) and production.” Zhihong Mei pointed out, “Thanks to TMPA for supporting the development of TEDA’s enterprises, and TEDA will also provide a variety of necessary services and support for the training base, making sure its smooth & efficient operation. TEDA is expecting the biopharmaceutical enterprises represented by Asymchem to further expand and strengthen, and to boost the further development of the biopharmaceutical industry cluster in TEDA.” Rui Yang also commented, “Asymchem is one of the second batch of training base enterprises cooperating with TMPA, this is a high recognition for Asymchem and also a pioneering initiative in the CDMO industry. In the future, Asymchem is going to bring together domestic & overseas senior pharmaceutical experts and to provide on-site guidance, which should benefit the regulation and management levels of drug supervisors. Meanwhile, we will put efforts into improving the GMP practical ability and talent compliance awareness of the enterprises. I believe that TMPA and Asymchem will work together to build strength for the future of the pharmaceutical industry.”
After the ceremony, Xudong Wang and other guests visited the Centers for Excellence of Process Science and Analysis & Testing, the AD Labs, and the Formulation Workshop. All of them commended and acknowledged the international & standardized operation patterns of Asymchem. Guests had thorough discussions afterward, mainly about the training plans of the base and ideas for innovative medical administration.
Local government collaborates with Asymchem to promote new drug administration mode
On July 1, the new “Provisions for Supervision and Administration of Pharmaceutical Production” will be put into effect, which refines the implementation path based on the “Drug Administration Law”. It provides the rules, procedures and requirements to be directly followed, systematically answers the questions about what and how to regulate under the new institutional mechanism. At the same time, higher and stricter requirements have been put forward on how enterprises can respond to changes in the legal system and strengthen the implementation of subjective responsibilities. In this context, “Tianjin Drug Administration Training Base” relies on an innovative “Government & Company” model of collaboration. The collaboration aims to discover the scientific method of drug regulation, fulfill the demand for high-quality expansion of pharmaceutical industries, speed up the improvement of Chinese medical products’ R&D and production levels, and to create a top model training base in China.
In the discussion, Xudong Wang expressed his expectation towards the training base-"Based in Tianjin, facing the country, introducing an international vision and aiming at the win-win result." The training base is a pioneering project for both the government and Asymchem. It will rely on the strength of both sides to promote joint development and realize sufficient resource sharing and collaboration. TMPA will use its advantages on a thorough understanding of laws & regulations and its enriched practical experience of regulations to provide companies with expert guidance about “Provisions for Drug Registration”, “Provisions for Drug Production Regulation”, “Quality Consistency Evaluation for Generic Drugs” and other related areas. In addition to those policies and laws, all-staff standard training is included. These trainings will largely improve the compliance capability of all industries. TMPA will also survey and learn more about companies, listen to their suggestions and questions, and come up with specific solutions that boost the R&D and production success. Asymchem is a world-leading one-stop CDMO service provider serving R&D and the production of pharmaceutical drugs. Asymchem has forefronted R&D skills, R&D production experience, and talented personnel. Therefore, Asymchem will leverage its profession and resources of domestic & international specialists to carry out trainings in drug R&D, advanced techniques, production processes and other related areas for drug supervisors. This will allow both sides to discover a more scientific model of drug regulation.
With the opening of “Tianjin Drug Administration Training Base”, Asymchem and the government will cooperate closely in the future to attract domestic specialists to interpret policies and communicate on this great platform. We are confident the level of Chinese drug regulation, R&D, and production can develop continuously, and bring the level of drug regulation onto a brand new peak in the near future!