management of non-first-time imported medicinal materials will be simplified

In order to strengthen the supervision and management of imported medicinal materials and ensure the quality of imported medicinal materials, the State Administration of Market Supervision and Administration recently issued the revised Measures for the Administration of Imported Medical Materials (hereinafter referred to as the Measures). The Measures require that in the management of imported medicinal materials, strict implementation of the "four most stringent" requirements, strict standards for the implementation of medicinal materials, and strengthen traceability management. At the same time, we will implement the reform requirements of "release clothing" and classify the first imported and non-first imported medicinal materials.

Imported medicinal materials are an important part of Chinese medicinal materials resources, and most of the exporting countries are "one belt and one road". In order to encourage the importation of medicinal materials, the measures abolished the restrictions on "allowing the import of medicinal materials at frontier ports and importing medicinal materials from neighboring countries or regions", and implementing the "one belt and one road" initiative, reflecting the spirit of interconnection.

Deepen the reform of "release control clothing" and implement classified management. The examination and approval of the first imported medicinal materials is entrusted to the provincial drug supervision and administration department where the applicant is located. Sample inspection originally undertaken by China Food and Drug Verification Research Institute is adjusted to the provincial drug inspection agency accordingly. It is worth noting that according to the risk level, the import management of non-first-time imported medicines has been simplified. The applicant can go directly to the Department responsible for drug supervision and management at the port or the border port for the record, and handle the customs clearance of imported medicines.