WANG Lei,CHEN Yu-wen*,HAO Gui-ming

(1.School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;

2.Department of Chemistry,Tianjin Institute for Drug Control,Tianjin 300070,China)

Drug Evaluation Programs in China: Problems and Countermeasures

WANG Lei1,CHEN Yu-wen1*,HAO Gui-ming2

(1.School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;

2.Department of Chemistry,Tianjin Institute for Drug Control,Tianjin 300070,China)

Objective To put forward suggestions for drug evaluation programs in China. Methods Problems of drug evaluation programs were analyzed through literature overview and field research. Results and Conclusion There exist some problems and defects in drug evaluation programs in China. It is suggested that sampling and testing programs can be improved to optimize drug evaluation programs in China.

national drug evaluation program; sampling; testing; drug control

The national evaluation is one of the important parts of China’s drug testing system. It is “the random inspection of the overall level of drug quality for pharmaceutical supervisory and administrative departments[1]”. Through the evaluation,national drug regulatory departments can understand the current level of drug quality in China which in turn help to improve the effectiveness of drug quality management and supervision. What is more,it enables the national drug supervision and management departments to formulate policies to promote the development of pharmaceutical industry and ensure safety use of drugs[2]. In recent years,through continuous exploration and improvement,drug evaluation programs have made great progress,but there are still some problems to be solved. This paper attempts to make some suggestions on improving the national drug evaluation programs after analyzing the problems in the system of drug evaluation.

1 Problems in the national drug evaluation programs

1.1 Problems about the relevant regulation of the sampling

Sampling is the beginning of drug evaluation which is the direction of the whole process. Drug evaluation should be carried out under the guidance of national law,and it determines the quality of drug directly. The related regulations on drug evaluation mainly include “Rules for Drug Quality Sampling” and testing,annual inspection plan and “Notice of National Drug Sampling Procedures (Provisional)”,etc.

1.1.1 The proportion of sampling distribution is bad

National drug sampling plan only specifies the number of sampling group for one product in the process of marketing and application. The sampling basis is too simple,and other factors,such as market share,the choice of sampling areas (urban and rural) are not reflected in the sampling plan. It can not objectively and accurately reflect the overall level of the product quality.

1.1.2 Problems about procedure of sending sample

Although the “National Drug Sampling Procedures (Provisional)” made specific provisions for the sample sent,due to various reasons,there are still problems in some work. In practice,infusion drugs are often found to have the phenomenon of breakage in the process of sending samples. Because of the large sizes and big numbers or the delay of mail system,they all can cause such a problem as batch samples could not arrive at the same time. And some samples which need to be refrigerated to preserve got damaged even if they are in accordance with the provisions that ice pack should be put on the samples[3].

1.2 Problems about related regulations

Specific testing work on samples is the highlight of the national drug evaluation programs,and it should be carried out with great caution. The regulation requires that the total samples should have compulsory inspection which makes it a heavy workload.

Samples for evaluating must be collected from various provinces and cities nationwide which mean a large number of drugs are brought together. As the regulation stipulates that all the samples must be tested according to the drug standard,the task becomes arduous and it requires a lot of manpower,material and financial resources to ensure the smooth progress of the entire work. In addition,the provincial drug control agencies are in charge of drug evaluation,and they also bear the daily work of testing other numerous varieties. It is likely to result in a reduction of work efficiency and low quality.

1.3 Problems about imperfect system of national drug evaluation

After the completion of related drug testing,the government will require the testing departments to dispatch the report to the sampled units and different provincial (autonomous regions and municipalities) drug control institutes. As to the substandard batches,an investigation should be made and the announcement of drug quality will be published. But these follow-up measures cannot fully make good use of the results of national drug evaluation programs,and some other measures should be added to improve the evaluation programs.

1.3.1 The lack of communication and transformation regulation in related national programs

Research work on national drug evaluation will use non-standard methods to explore the quality of medicines. The development of new quality standard,the investigation of the dissolution behavior of solid dosages and the establishment of the quick testing method are 3 important contents of the research work. But there are no related specifications and requirements for improving evaluation programs which are in accordance with national drug standard,generic drug consistency and a fast drug testing platform.

1.3.2 The research work can not be used by manufacturers

The exploratory research work will study the whole process of the drug,and it can find out the root of drug quality problems in the production process. At present,there is no regulation provides that manufacturers must apply to the research work. Therefore,the research work becomes a waste of time and money.

2 Suggestions on the improvement of national drug evaluation programs

2.1 Improvement and supplement of drug sampling regulation

2.1.1 To enrich the design factors for sampling distribution proportion

For a specific sampling product,its quality has a great effect on its market share. China is one of the developing countries and the economic development levels between cities and towns are uneven. Due to the limitation of economic condition,the quality of the drugs cannot be guaranteed in the villages and towns. Therefore,in the sampling plan,market share and the proportion of sampling varieties from urban and rural areas should be taken into consideration. In addition,the proportion of production,circulation and use of the sampling drugs should be determined specifically so that it can become more operational. Designing a scientific and reasonable proportion of sampling distribution is an important premise for drug evaluation programs.

2.1.2 To standardize the delivery of sampling products

The government can select a number of professional pharmaceutical logistics companies. A list of these companies is included in the sampling procedures so that each sampled unit can make its choice by using the professional logistics facilities around the country to send the samples to a testing unit. It can ensure the delivery will not be affected and retain the samples in the original state. This can guarantee the quality of sampling products and it is significant for the evaluation programs to obtain accurate results.

2.2 The improvement of testing regulation

2.2.1 To change the request for total testing and determine the key items scientifically

Some scholars[4]pointed out that the products with unstable quality should be inspected and we can drawlessons from foreign (EU) annual inspection programs. The drug review departments,drug R&D departments and relevant technical personnel of enterprises can work together to put forward the key parameters that affect the quality of the products in combination with different drug risk index,then the inspection items can be determined.

2.2.2 To establish the testing department and introduce the other drug-related agencies

In China,there are many medical universities and research institutions with high technical levels. The authorities should take them as a candidate for drug evaluation programs. They can cooperate with the local provincial departments for drug control or they can finish the whole programs themselves which will improve work efficiency.

Moreover,with the growing number of the third-party inspection agencies,they can get involved in the evaluation programs once they have the relevant qualification,while provincial drug control department can focus on exploratory research work. Even an excellent third-party inspection agency can undertake the whole programs of some varieties.

2.3 Supplementary regulations for results of national drug evaluation programs

2.3.1 To establish an exchange mechanism for exploratory research work and other relevant national departments

China’s drug administration should establish an exchange mechanism for national drug evaluation programs,national drug standard,generic drug consistency evaluation and a fast drug testing platform. Therefore,the results and suggestions involved in drug standards can be directly used for the improvement of drug quality; while the results involved in generic drug consistency evaluation and a rapid drug testing platform can be transformed into reality which greatly improves work efficiency.

2.3.2 To establish the cooperation between the research work and the manufacturer

The results of exploratory research work related to the production process can promote the product quality and a cooperation should be established so that the relevant manufacturers can get the results in time for further use. The testing unit should put improvement suggestions for each manufacturer in the report respectively. After the national audit,the report should be passed to each manufacturer. At the same time,manufacturers should have feedback channels for testing units and national departments so that they can work together to promote drug quality.

3 Conclusions

As mentioned above,there are still some problems in the national drug evaluation programs including the design of sampling distribution,sample delivery,inspection cycle and the use of results. China’s drug regulatory authorities should improve its drug evaluation system and it will have a practical significance in the future.

[1]CFDA notice of drug quality sampling and testing regulations [EB/OL]. http://www.sda.gov.cn/WS01/CL0055/10583.html,2006-07-21.

[2]ZHENG Jie. Problems and suggestions on post marketed drugs for quality assurance system [D]. Shenyang Pharmaceutical University,2011: 22-23.

[3]XUE Jiao,ZHANG Zi-zhi,WANG Xin-yi. Problems and suggestions about the procedure of samples in national drug evaluation programs in 2011 [J]. Northwest Pharmaceutical Journal,2013,28 (1): 93-94.

[4]LI Jing-li,HUANG Zhi-lu. Discussion on optimized design for national drugs sampling and obtaining the maximum benefits [J]. Chinese Pharmaceutical Journal,2012,47 (13): 1094-96.

* Corresponding author: CHEN Yu-wen,professor. Major research area: pharmacy administration. Tel: 15940448000,E-mail: cywwyc@163. com