The Study Of Radioactive Drugs Registration Management System In China

Currently radiopharmaceutical is special drug management by China government. Relevant regulations have been set up and improved to resolve the raising issues during radiopharmaceutical products registration, but we still have certain gaps compared to international advanced level. The management models of US and EU have been well-established and recognized globally. This paper is to adopt literature method, questionnaire survey method and comparison method, to analysis how to perfect the radiopharmaceutical product registration management system from the aspects of the legislation system, the organization establishment, the registration and approval procedures, the registration documentation etc.US has certain revision mechanism of regulations and well-established registration regulation management system especially on technical guideline for industry. There is a specific evaluation department in CDER of FDA, and RDRC has been set up for the evaluation of basic research trails. The evaluation procedure of US is much simple than China since no need to get approval for clinical trial. FDA also issued a unique approval procedure and related cGMP requirement for PET products in recent years to encourage PET development. In terms of registration documents, FDA adopts CTD model and the content requirement is more specific than China.There is some specific requirements for radiopharmaceutical in EU basic drug registration regulation (2001/83/EC). The technical guidelines for radiopharmaceutical are also comparable complete. EU will revise their regulations and laws bases on the requirement of its member countries. In terms of registration organization of EU, it is same as China, no specific evaluation department for radiopharmaceutical since the technical evaluation is based on products categories. However, the registration procedure of EU like US, is worthy for our learning:it only requires Ethics Committee’s review for clinical study and no need to get EMA’s approval, that means only once submission and approval for production. That is the reason why the approval procedure is simpler than china, and the approval timeline is shortening than us as well. Again, EU developed some guideline for radiopharmaceutical, so the registration documents requirements are comprehensive. Compared to US, the common requirement and principle of guidelines for radiopharmaceutical between US and EU are basic consistent except of some details. The relevant specific regulations for PET are under preparation by EU.In a word, we can learn from US and EU regarding to radiopharmaceutical registration management from the perspectives of the legislation system, the organization establishment, the registration and approval procedures, the registration documentation etc.Through the comparison and analysis of radiopharmaceutical registration management system in China, US and EU, it point out the major issues currently existing in Chinese radiopharmaceutical registration management system:lack of the clear definition and scope of radiopharmaceutical, the revision mechanism for the upper law is not perfect; no independent evaluations office for radiopharmaceutical, no specific registration procedure for radiopharmaceutical, registration documents requirement is not clear as EU and US since China don’t have technical guideline for radiopharmaceutical especially for PET products.To solve above problems, combining Chinese radiopharmaceutical registration management current situation, refer to EU and US’s successful experience, this paper puts forward proposals on perfecting the radiopharmaceutical registration management:should explicit the definition and scope for radiopharmaceutical, revise current relevant regulations and develop comprehensive industry guideline; in the aspect of management department setup, we should set up a special office to approve radiopharmaceutical; in the aspect of registration management procedure, our country should set up the specified approval procedure and requirement for radiopharmaceutical especially for PET product; in the requirement of registration documents, we should refer to adopt international format.The suggestions put forward involve full consideration of actual conditions in China and establish a certain foundation for the further study for the revision of radiopharmaceutical registration regulations and policies so that we can be better in line with the international advanced level.