Ex-post Evaluation

1. Outline of the Project

Country:

China

Project title:

Tianjin Pharmaceutical Inspection Center Project

Issue/Sector:

Health/Medical Care

Cooperation Scheme:

Project-type Technical Cooperation

Division in Charge:

Medical Cooperation Department, First Medical Cooperation Division

Total Cost:

Period of Cooperation

6 November 1993 – 5 November 1998

Partner Country’s Implementing Organization:

China Pharmaceutical Supervisory Management Division, Tianjin City Pharmaceutical Supervisory Management Division, Tianjin Pharmaceutical Inspection Center

Supporting Organization in Japan:

Ministry of Health, Labour and Welfare

Related Cooperation:

1-1 Background of the Project

Tianjin City is one of the important bases in China for manufacturing pharmaceuticals. Many domestic and foreign pharmaceuticals sold in China enter the market via the Tianjin port every year. The Tianjin Pharmaceutical Inspection Center (Hereinafter referred to as the “Tianjin Inspection Center”) implemented quality control and inspection of statutory pharmaceuticals under jurisdiction of the Tianjin City Pharmaceutical Supervisory Management Division, and is responsible for control of imported pharmaceuticals. Although the Chinese government strived to strengthen pharmaceuticals quality control under the seventh and eighth five-year plans (1986-1990, 1991-1995) for smooth enforcement of the Drug Administration Law, the quality at that time was below international standards. Under the circumstances, the Chinese government requested that Japan implement a Project-type Technical Cooperation project in order to ensure the safety and effectiveness of pharmaceutical products through strengthening of quality control and inspection management.

1-2 Project Overview

(1) Overall Goal
The effectiveness and safety of pharmaceutical products distributed in China is guaranteed through quality control activities.

(2) Project Purpose
Level of pharmaceutical quality management at the Tianjin Inspection Center and work technology standards are improved.

(3) Outputs
1) GLP (Good Laboratory Practice; Standard of non-clinical trials on safety of pharmaceuticals) is understood and implemented.
2) Analysis method validation (evaluation on a method of analysis) is understood and disseminated.
3) Pharmaceutical inspection technology is improved
4) Inspection facilities are set up and expanded.
5) Technicians involved in pharmaceutical inspection are trained.
6) Joint research of pharmaceutical quality management is carried out.
7) Technology and research information is exchanged between pharmaceutical inspection centers in other provinces.

(4) Inputs

2. Evaluation Team

Members of Evaluation Team

Team Leader/Generalization: Kazuhiro Yoshida (Office of Evaluation and Post-project Monitoring, Planning and Evaluation Department, JICA Head Office)
Analysis of post-project evaluation: Tsuyoshi Ito (IC Net Ltd. )
Analysis of post-project evaluation: Li Wei (Beijing Manyo Consultants Co., Ltd.) (local consultant)
Interpretation and study assistance: Liu Ran (JICA China Office)

Period of Evaluation

24 February 2002 – 9 March 2002

Type of Evaluation:

Ex-post Evaluation By Overseas Office

3. Results of Evaluation

3-1 Summary of Evaluation Results

(1) Impact
The China Pharmaceutical Codex was revised to comply with international standards. In the revision process, some staff members from the Tianjin Inspection Center served on the pharmaceutical codex revision committee and were in charge of establishing the standards for 80 pharmaceutical and quality measurement methods. Consequently, with regard to the overall goal of "the effectiveness and safety of pharmaceutical products distributed in China are guaranteed," it appears that "a guarantee of the effectiveness" is ensured. On the other hand, regarding " a guarantee of the safety," currently GLP has not been adopted and there has been no impact. Although there was no impact as regards improved safety, since it was not in keeping with the project’s focus, it can be concluded that the lack of an impact is not a significant problem, but that the inclusion of “a guarantee of the safety” to the overall goal itself was a problem.

In addition, impact not anticipated at the project completion were seen as follows:
1) The Tianjin Inspection Center made technical contributions to the efforts of Chinese capital pharmaceutical manufacturing companies for their new product developments. From 1998 to 2001, there were 400 cases of reference for new medicine approval.
2) The Tianjin Inspection Center holds activities to disseminate its skill and knowledge,in particular, the HPLC (high-performance liquid chromatography) method and the Rapid inspection method for counterfeit medicine to other inspection centers through seminars and training. This counterfeit detection method is recognized as the national standard inspection method, and efforts are being made to develop an inspection kit for dissemination.

(2) Sustainability
1) Out of 28 people who received technology transfer in the Project, 23 continue to work at the Tianjin Inspection Center; therefore, transferred technology is practically used. Also, most of the counterparts are given higher responsibility, such as Center Director. From these points, sustainability in human resources is ensured.
2) Tianjin City went through structural reforms in 2000, and the Tianjin Inspection Center fell under the jurisdiction of the city's Pharmaceutical Management and Supervisory Agency. This did not, however, cause any significant organizational changes to the inspection center itself.
3) In financial aspects, out of the Tianjin Inspection Center's annual budget, a maximum of 35 percent represents owned capital, but the figure fluctuates. The center receives financial support of more than 3.5 million yuan per annum from the Tianjin City government. Roughly the same budget can be expected in the future, but concerns remain in terms of the financial sustainability as its fiscal condition is comparatively weak. Equipment maintenance expenses required are around 800thousand to 1.1 million yuan (approximately 20 percent of the budget) and the work level at project completion can be maintained. As the equipment hereafter comes close to the end of its service life, expenses for purchasing spare parts are expected to rise; Thus the issue of financial resources is likely to become more serious.
4) In technical aspects, research activities related to pharmaceutical quality standards have been continuing (out of 589 cases from 1998 to 2001, 311 cases were related to the pharmaceutical codex). As methods of applying the transferred technology, such as a rapid inspection method for detecting counterfeit medicine, have been developed through it’s the Center’s own effort, technical sustainability is high. However, since there is insufficient access to the latest technical information, it is possible that competition with other key inspection centers could become severer, and the technical level of the center could fall behind that of the private pharmaceutical companies in the near future.
5) In sustainability of project effects, conformity of GLP was not achieved at the time of the study. The number of seminars held for other pharmaceutical inspection centers and pharmaceutical inspection technicians, and the number of participants have been falling. Some of the project effects are observed to fade. However, the advanced nature of the HPLC techniques of the Tianjin center is recognized nationwide, and the Tianjin center is responsible for reexamining the standardization of HPLC analytical methods at other inspection centers. In this respect, project effects are maintained and developed.

3-2 Factors that promoted realization of effects

(1) Factors concerning Planning
N/A

(2) Factors concerning the Implementation Process
1) The government's efforts in the quality management of pharmaceutical products became more rigorous due to the structural reforms in pharmaceutical product management in 1998 and accession to the WTO. In 2001, the new drug administration law was executed and it pushed the effort of quality management among the pharmaceutical companies. Similarly, the government has been strongly committed to the countermeasures against counterfeit medicine since 2000; consequently, the target (both the regions and product variety) expanded. In this respect, these favorable environments towards pharmaceutical management brought about the overall impact.
2) As the Tianjin Inspection Center actively carried out technical instruction for the private pharmaceutical manufacturing companies in the Tianjin city vicinity, it made a significant contribution to the quality management techniques of Chinese capital companies and the development of new medicines

3-3 Factors that impeded realization of effects

(1) Factors concerning Planning
Despite the overall goal that "the effectiveness and safety of pharmaceutical products distributed in China are guaranteed," the effects regarding the safety have not been realized. Another project of the National Pharmaceutical Supervisory Management Division is carrying out aims to ensure the safety, and there has been no direct impact through this project. This is caused by positioning "the safety" in the overall goal in parallel with "the effectiveness," even though this project's primary focus is “a guarantee of the effectiveness."

(2) Factors concerning the Implementation Process
N/A

3-4 Conclusion

A foundation for sustainable development has been built up through the independent efforts of the Tianjin Inspection Center during and after the project. However, the increase in inspection demand is higher than anticipated when the project started, and making funds and additional input for technology essential in maintaining sustainability into the future.

3-5 Recommendations (specific measures, proposals and advice for this project)

(1) The primary issue of the Project is maintaining financial and technical sustainability. In preparation for inspection demand, which is expected to increase further, additional input for facilities and equipment and access to the latest information for developing new technologies must be ensured.

(2) To guarantee financial sustainability, the priority of the financial support from the central government should be carefully examined by looking at the role and importance of each inspection center and the public finance abilities of the regional governments together, rather than simply dividing it by regions (the central-west regions, the coastal areas, etc.)

3-6 Lessons Learned (matters which are helpful to identification/creation, implementation and management control of other similar projects)

(1) To make some impacts on "the consumers," the final beneficiaries, it is necessary to clarify that an active approach to private companies will be made in the project.

(2) In some cases, technical progress is swift and it is necessary for the latest information to be available all the time. There is a need to establish some form of constant mechanism for information exchange with Japanese organizations holding the latest information by the end of the project implementation in order to maintain project effects.

(3) When sustainability of project effects is inhibited by changes in the external factors, such as increased demand, it is recommended to search for possibilities of follow-up assistance in order to enhance the institutional capability of the implementing agency that the completed project built up.

3-7 Follow-up Situation

N/A