Research On Legal Protection Of Drug Test Data In China

The measurement of drug test data is an important criterion for drug safety and efficacy. It also involves huge economic benefits. The legal system for the protection of pharmaceutical test data gradually formed in nearly half a century, and becoming an important part of the TRIPS Agreement, bilateral agreements and national legislation. The TRIPS Agreement has played the role of the minimum standards of protection.What’s more; many of the concepts are still controversial. Protection standards of pharmaceutical test data differ from one country to another. After joining the WTO, China has initially established the legal system of protection. However, the key elements are still not clearly defined and lack of implementation details of conditions still exists. In order to deal with the pharmaceutical data protection issues in the future, and to improve the legal system, we are in great need to compensate for the vulnerability on the substantive law and procedural law.