NMPA Issued the Announcement on Issues Pertaining to the Current Administration on Drug Distribution
On April 3, 2020, NMPA issued the Announcement on Issues Pertaining to the Current Administration on Drug Distribution, which contains the following contents:
The newly revised Drug Administration Law of the People's Republic of China (hereinafter referred to as Drug Administration Law) came into force as of December 1, 2019, and the formulation of relevant supporting departmental rules and regulations is ongoing. To implement the relevant requirements of the Drug Administration Law and further clarify and standardize the supervision and management of drug distribution, the relevant matters are hereby announced:
1. As form the implementation of the newly revised Drug Administration Law, unless the promulgation of relevant supportive departmental regulations stated otherwise, the Regulations on Drug Distribution License (Former CFDA Order No. 6) and the Provisions for Supervision of Drug Distribution (Formerly CFDA Order No. 26) remains valid and, where their provisions are inconsistent with the Drug Administration Law, the latter shall prevail.
2. Where a newly establishing drug distributor applies for the issuance of a Drug Distribution License, the drug administration departments may combine the examination & approval procedures for establishment preparation and acceptance, and organize inspection over the applicant pursuant to the relevant requirements of the Good Supply Practice for Pharmaceutical Products (GSP) and on-site inspection guidelines. A Drug Distribution License shall be issued if requirements are met.
3. Where a drug distributor applies for renewal of a drug distribution license, the drug administration departments shall conduct a review in accordance with the procedures for renewal of licenses and relevant requirements for establishment. The license shall be renewed if the conditions comply with the GSP and the renewal requirements (or conditions met after rectification). Where the requirements are still not met after rectification, the license shall not be renewed.
During the prevention & control of the COVID-19 epidemic, relatively flexible regulatory measures can be taken, where necessary, for registration items of renewals and alterations. Where the enterprise cannot complete the application dossiers and on-site inspection preparations on time due to the epidemic situation, the validity period of its Drug Distribution License may be extended up to 90 days after the local epidemic prevention and control emergency response is lifted. Where the application for alterations of Drug Distribution License requires on-site inspection, the method of Informing & Pledging may be adopted. After the applicant submitted the application for alteration and commitment for GSP compliance, drug regulatory department shall handle the relevant licensing matters as a first step, and then complete the on-site inspection within 90 days after the local emergency response for epidemic prevention & control is lifted.
4. Where a drug distribution enterprise is subject to operation suspension since its GSP Certificate are cancelled or withdrawn due to GSP violations prior to December 1, 2019, it shall rectify the violations within the time limit required by the previous administrative measures. After the rectifications are in place, the enterprise can apply for resumption of operation, and resume business activities where conditions are met after review by drug administration departments; if rectifications failed to be made within the time limit, Article 126 of the Drug Administration Law shall apply.
5. Drug Marketing Authorization Holders shall abide by the provisions of Article 34 of the Drug Administration Law while selling their drugs that have obtained drug registration certificates. Pursuant to the Reply on Issues Pertaining to Drug Production and Circulation in the Pilot of Drug Marketing Authorization Holders System (NMPA Department of Drug Supervision Letter No. 25 ), for consignment sales contract signed by MAH (Marketing Authorization Holder) and entrusted drug manufacturer prior to December 1, 2019, the entrusted manufacturer may sustain drug sales within the contract period but not beyond (in principle, the MAH-entrusted drug manufacturer's sales shall Not exceed December 31, 2022). As per the Drug Administration Law, after December 1, 2019, drug MAH shall not sign consignment sales contracts with entrusted drug manufacturers, and shall be ordered to make corrections within a time limit if they do so; if the MAH fails to correct the breach within a prescribed period of time, Article 115 of the Drug Administration Law shall apply.
6. Drug MAHs, manufacturers, distributors and user units should follow the NMPA Guiding Opinions on the Construction of Drug Information Traceability System (NMPA Department of Drug Supervision (2018) No. 35) and the NMPA-formulated unified standards and specifications, actively carry out the construction of drug information traceability system, and implement whole-process traceability by categories and stages in accordance with the subsequent work deployment of the NMPA.