The pharmaceutical product R&D, examination and approval in China will be affected by the concept and approach brought by the global cooperation and development. For example, in order to accelerate pharmaceutical product approval, the U.S. introduced the act that the pharmaceutical product registration shall be paid by users and has introduced the act for charging the generic drugs recently. In addition, the clinical trial flow is optimized via the third party organization, and the "Reform Act for the 21st Century" is carried out to study how to accelerate R&D and drive international administration and cooperation. The Europe is also quite experienced in, such as, conditional approval and experimental approval.
China also makes practices and exploration in fields relevant to pharmaceutical product registration, such as the stipulations of special approval and particular approval, the fast channel measure for the new drugs, and the modes of rolling submission of materials and strengthening communication, having adopted some international methods. The accelerated policy guidance and entrustment to partial provincial administrations for examining technology transfer of pharmaceutical products can be taken for the generic drugs urgently needed by the clinic.
Furthermore, registration management of packing materials and excipients will be adjusted: the registration and approval of packing materials and excipients are planned not to be conducted separately in 2015, but associated examination will be conducted during application of pharmaceutical product preparations, to reduce approval and burdens of enterprises. The filing work on packing materials and excipients is currently under study and guidance will be introduced as soon as possible.
