The State Drug Administration ("SDA") has recently distributed the Circular on Maintaining Effective Drug Regulation During the Institutional Reform (the "Circular").
The Circular expressly states that before adjustments to functions of the institution are fully completed, matters in relation to drugs, such as the administrative licensing, supervision and inspection, testing, inspecting enforcement, complaints and tip-offs, and information disclosure, shall still be handled under the existing rules, until new rules and systems are launched. Current applicable formalities for filing applications for administrative licensing for drugs, and accepting, examining and approving such applications, the format of administrative licenses and relevant documents, and business seals will remain unchanged temporarily, so as to ensure the continuity of routine work. In addition, the Circular calls for tightening routine oversight of drugs and severely combatting various forms of violations and illegalities, such as adding impurities to traditional Chinese medicine decoction pieces and illegally dealing in drugs online. Furthermore, the Circular calls for efforts to constantly deepen reform of systems applicable to the evaluation and approval of drugs and medical devices and advance the practical implementation of various major reform tasks, including the creation of archives for varieties of drugs and medical devices and the consistency evaluation of quality and efficacy of generic drugs.