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At a webinar on the safety management of precursor chemicals held on August 23, 2022, Mr. Guo Shuai, an official from China's National Registration Centre for Chemicals (NRCC), elaborated on national efforts in the management of precursor chemicals and the potential regulatory amendments in the future.
In China, precursor chemicals are regulated under the Regulation on the Administration of Precursor Chemicals (2005)1, an administrative regulation known as Decree No. 445 (hereafter referred to as the Regulation). The Regulation adopts classified management and licensing system for the production, distribution, purchase, transport, import and export of precursor chemicals. The future amendment will add provisions to fix legislative loopholes in warehousing and use of precursor chemicals, according to Mr. Guo.
In addition, China is planning to delegate the power of designating precursor chemicals to various ministries. At present, the addition of precursor chemicals should be jointly proposed by six ministries under the State Council, including the Ministry of Public Security (MPS), the Ministry of Commerce (MOC), the Ministry of Emergency Management (MEM), the National Health Commission, the General Administration of Customs (GACC) and the National Medical Products Administration, and submitted to the State Council for review.It will take great effort and much time in coordinating among ministries and waiting for approval by the State Council, which is the main reason why in the past 17 years only 15 precursor chemicals were added. Considering the fact that new types of drugs appear due to advances in chemical synthesis technology and there is a risk if we do not regulate the raw materials and agents of new drugs as soon as possible, accelerating the designation process for precursor chemicals is necessary. Mr. Guo gave an example that in the future non-drug precursor chemicals that are also classified as hazardous chemicals can be jointly designated by the MPS and the MEM, and there is no need to discuss with the other four ministries.
What’s more, it is planned to adopt a mechanism for the temporary designation of precursor chemicals. The authorities can quickly respond to emerging chemicals and subject them to precursor chemical management for one year (can be extended for another year if needed). They can be designated as precursor chemicals according to the normal process if determined to meet the designation criteria during the temporary management period.
According to Mr. Guo, the drafting work was launched at the end of 2021, following a preliminary investigation that started at the end of 2019. The Regulation will not be overhauled. Instead, the amendments will be published in the form of a separate document. So far, a draft has been drawn up for an internal consultation among the six administrative authorities.
The Measures of the Administration on Manufacturing and Operation license for non-drug precursor chemicals (SAWS Order No.5)2 which was promulgated in 2006 will also be revised to align with the potential amendments of the Regulation.
Introduction of Precursor Chemicals Precursor chemicals are classified into three categories. Category I includes the major materials that can be used for producing drugs. Categories II and III include the chemical agents that can be used for producing drugs. The precursor chemicals in Category I are further classified into drug precursor chemicals and non-drug precursor chemicals. The Catalogue of Classification and Types of Precursor Chemicals3 is an appendix to the Regulation. When it was published in 2005, 23 kinds of precursor chemicals were listed. The catalogue is subject to continuous renewal and should stay current with the trends.
*a: 4 of them are drug precursor chemicals; *b: 5 of them are included in the List of Hazardous Chemicals (2015); *c: 7 of them are included in the List of Hazardous Chemicals (2015). |
