On Nov 24th, China’s State Council published its decision to cancel or streamline 58 items previously requiring administrative approval or licensing, 67 professional qualification licensing or grading items and 19 evaluation and commendation items. The State Council also adjusted 82 other items previously subject to premarket registration approval to post market approval. Since last May, China has been instituting large-scale administrative reforms of the Government and almost 600 such schemes have been annulled or streamlined.
Some of the items are listed as follows:
Chemical
Serial number | Item | Competent authority | Reference document | Decision |
I-25 | Issuance of inland waterway shipment pollution / damage liability insurance certificate or financial guarantee | Ministry of Transport | State Council Decree 591 | Cancelled |
I-32 | Approval for manufacturing Class I drug precursor chemicals | CFDA | State Council Decree 445 | Decentralized the power to provincial FDAs |
II-15 | Safety assessment personnel qualification | SAWS | SAWS Notice 108 of 2005 | Cancelled |
IV-8 | Hazardous waste business licensing | Provincial EPAs | Solid Waste Prevention and Control Law, State Council Decree 408, State Council General Office Notice 44 of 2013 | Pre-business registration approval adjusted to post-approval |
IV-18 & 19 | Refined oil products business licensing (wholesale & retail) | MOFCOM / Provincial departments of commerce | State Council Decree 412, State Council General Office Notice 72 of 2001 | Pre-business registration approval adjusted to post-approval |
IV-72 | Hygiene license of disinfectant manufacturers (except one-off medical products) | Provincial departments of health | State Council Decree 412 | Pre-business registration approval adjusted to post-approval |
IV-78 | Approval for manufacturing or operating Class I non-drug precursor chemicals | Provincial administrations of work safety | State Council Decree 445 | Pre-business registration approval adjusted to post-approval |
Pharmaceuticals and medical devices
Serial number | Item | Competent authority | Reference document | Decision |
IV-40 | Approval for online pharmaceutical trading service companies | CFDA and provincial FDAs | State Council Decree 412 | Pre-business registration approval adjusted to post-approval |
IV-41 | Approval for internet information services of pharmaceuticals and medical devices | Provincial FDAs | State Council Decree 292 | Pre-business registration approval adjusted to post-approval |
This September, Premier Li Keqiang spoke at the summer’s Davos Forum opening ceremony where he clarified the boundaries of responsibilities and powers of the Chinese government into 3 lists which he termed the “Power Liist”, "Negative List" and "Duty List". The "Power List" defines what the government can do and the areas where the government shall not intervene. The “Negative List” specifies what enterprises shouldn’t do and areas where industry behaviors should remain self-regulated. The “Duty List” indicates how the government should regulate the market and how it will implement its regulatory control. The cancellation of the administrative approval requirements and simplification of many market entry procedures will bring great benefit and convenience to many industries and sectors.
